The results of esophagectomy with simultaneous esophagoplasty within the framework of the RAPOR program. Single-center experience of treating 500 patients

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BACKGROUND

The history of esophagectomy (EE) began in the USA in 1913, when Torek has performed the first EE using the thoracotomy access with simultaneous connection of the esophagostoma and the gastrostoma with the external rubber tube [1]. The next successful EE with the simultaneous formation of the esophagojejunal anastomosis was done by Oshawa in Japan only in 1933 [2]. The development of surgical methods and of the perioperative management (POM) for EE cases was occurring in parallel, out-competing each other in an alternating mode. The development of the artificial pulmonary ventilation and of the myorelaxants has “let loose” the surgeons and has allowed for developing the maximally sophisticated operative approaches. However, in 80’s of the ХХ century, even in the centers with considerable experience, the hospital mortality among the EE patients was still at the level of 6.0–15.4% [3],and at the end of 90’s — 5–10% [4].

The key milestone in the development of surgery in general and esophageal surgery in particular has become the development of the “fast-track surgery” by Henrik Kehlet. His research works on the effects of the stress-response in the organism to the post-operative complications and on the factors decreasing it, contributed to the evolution of the POM [5]. As a result, in 2001, the Enhanced Recovery After Surgery (ERAS) Study Group was founded. In 2005, the first ERAS-protocols for colorectal surgery were published. In 2010, the ERAS society was founded, which has gradually developed the recommendations and the protocols for various fields of surgery [6]. The basis of the ERAS concept contains a team-based multi-disciplinary approach to the patient, aimed at the fastest post-operative recovery and rehabilitation of the patient. However, the EE recommendations were compiled only in 2019 [7].

Nevertheless, the rate of complications after the EE remained high and varied from 17% [8] to 74% [9], However, the analysis of complications has been long time encumbered by the absence of the unified system for the registration of complications. This problem was solved in 2015 by developing the unified register of complications — the Esophagectomy Complications Consensus Group (ECCG) [10].

Based on the ERAS protocols, many specialized surgery centers have compiled their own protocols for perioperative management of the patients. Thus, at the National Medical Research Center of Surgery named after A.V. Vishnevsky (NMRCS) in 2012, the program of rational accelerated perioperative rehabilitation (RAPOR) was implemented for the patients undergoing EE with simultaneous esophagoplasty.

Research Aim: to evaluate the results of treating the patients after esophagectomy with simultaneous esophagoplasty within the framework of the rational accelerated perioperative rehabilitation program.

METHODS

Research design

A single-center non-randomized retrospective research was arranged. It included 500 patients after the scheduled primary EE with simultaneous esophagoplasty. Based on the obtained data, the parameters evaluated were the mortality, the rate and the severity of postoperative complications.

Conformity Criteria

Inclusion criteria. The research sample included all the patients in which a single operating surgeon had conducted the primary EE with simultaneous esophagoplasty within the framework of the program of rationally accelerated perioperative rehabilitation (RAPOR).

Exclusion criteria. The criteria for exclusion were the cases of EE without the reconstructive stage.

Non-inclusion criteria — emergency intervention, switching the operating surgeon.

Research facilities

The research was carried out at the National Medical Research Center of Surgery named after A.V. Vishnevsky (NMRCS).

Research duration

The duration of the retrospection was from 2012 until 2024.

Medical procedure description

The treatment of all the patients was arranged within the framework of the RAPOR program. It included an obligatory examination of the patient at the pre-hospital phase by the interdisciplinary team with evaluating the body mass index (BMI), the Charlson comorbidity index, the degree of anesthetic risk according to the standards set by the American Society of Anesthesiologists (ASA), the risk of cardiac complications according to the Lee scale and the risk of nutritional insufficiency according to the Nutrition Risk Screening 2002 scale (NRS-2002). Based on the obtained data, the extent of the pre-operational examination and preparation was prescribed. If necessary, the first stage included the nutritional therapy and the correction of the concomitant cardiovascular disorders.

After the correction of the somatic status, all the patients underwent the transthoracic (modified by McKeown) or transhiatal sub/total EE with simultaneous esophagoplasty with the gastric tube, with the colonic segment or with the combined gastrojejunal transplant (Fig. 1). Two hours before surgery, the recommendations included receiving the water load with high-hydrocarbonate drinks, while in the intraoperative period, normothermia was maintained along with normovolemia, other procedures included the protective pulmonary ventilation, the prevention of post-operative nausea and vomiting, of the thromboembolic and infectious complications. The installation of the pleural draining tube and the drainage in the subhepatic space was done after the thoracic access. The nasogastric decompression and the draining of the neck wound is omitted from 2017. After the end of the intervention, the patients in the majority of cases were extubated in the operating room and transferred for follow-up to the ICU, where the infusional and the antibacterial therapy along with the prevention of thromboembolic complications were continued. For the provision of the multimodal analgesia, an intraoperative installation of the paravertebral catheter was performed during the thoracotomy along with the epidural catheter/catheters into the sheath of the rectus abdominis muscles.

 

Fig. 1. Schematic representation of the variants of esophagoplasty with using the gastric tube, the colon segment or the combined gastrojejunal transplant.

 

In the morning of the first postoperative day (POD), the patients were transported to the specialized department with removing the urinary catheter and the pleural draining tube in case of aerostasis and in case of producing less than 400 ml of discharge. The subhepatic draining tube was removed on POD 2. When using the classic scheme of managing the patients, the complete parenteral feeding was prescribed until POD 5. Then followed the radiology or the CT control with allowing the oral intake of water. The intake of strained food was possible from POD 7 after the second X-ray control. Early oral feeding was allowed to the patients with the satisfactory quality of the cervical conjunction (positive intraoperative evaluation of the viability of the gastric transplant and of the esophageal stump), with the absence of aspiration or of the anastomosis failure upon the radiology control on POD 1. With the early initiation of food intake on POD 1, oral intake of water was prescribed, from POD 2 — sipping was allowed and from POD 3 after the satisfactory X-ray control findings the intake of strained food was permitted.

Research outcomes

Primary findings: evaluation of the rates, the type and the severity of postoperative complications.

Additional findings: evaluation of the post-operative mortality.

Subgroup analysis

For the evaluation of the additional outcomes, the parameters applied were the same as the ones used for the evaluation of the main outcomes.

Methods for registration of outcomes

For the verification of complications in the patients, the procedures included the routine radiography or CT-examination of the chest cavity organs and of the abdominal cavity with oral contrasting on POD 1 or 5 and on POD 3 or 7. The laboratory evaluation of the patient status was arranged on POD 1, 3–5 and 7–10. In case of worsening in the patient status, for the evaluation of the transplant viability or for ruling out the hemorrhage, CT-scanning was done with intravenous contrasting and with repeating the laboratory tests. Other complications were suspected based on the clinical data with further confirmation by means of the laboratory and the instrumental methods. The post-operative complications were evaluated using the ECCG unified register categories. The severity of post-operative complications was evaluated acc. to the classification by Clavien-Dindo. The isolated hydrothorax related to the early removal of the pleural draining tube on POD 1, was not considered a complication.

Ethical review

The arrangement of the research work was approved by the local ethics committee of the Federal State Budgetary Institution “National Medical Research Center of Surgery named after A.V. Vishnevsky” under the Ministry of Health of the Russian Federation (protocol No. 007-2024 dated 25.10.2024).

Statistical analysis

The statistical data analysis was done using the R software, version 4.3.1., 2023. The descriptive statistics was presented as the absolute rate for the categorical variable and as the median for the quantitative variables.

RESULTS

Research sample (participants)

We have analyzed 500 medical records of the patients receiving the primary EE with simultaneous esophagoplasty. The diseases of the esophagus were more often reported in males (59.8%). The median age was 59 years. With this, 12.8% of the patients were older than 70 years. In 46.4% of the patients, the past medical history has both the endoscopic (multiple courses of bougienage and dilation) and the cavitary interventions in the esophagus or stomach (fundoplication, cardiomyotomy, gastric resection or gastrectomy). In 54% of observations, the surgery was carried out for the reason of having the benign diseases of the esophagus: 25.6% — burn/peptic stricture, 22.8% — achalasia of the cardia grade 4, 1.2% — fistula, 4.4% — other benign diseases of the esophagus (short esophagus grade 2, multiple diverticula, gigantic polyp etc.). In the remaining patients, the indication for EE was the malignant neoplasm in the esophagus and in the esophago-gastric junction (46%). The neo-adjuvant therapy was received by 6% of the patients.

The medial BMI was 23.5 kg/m², but in 5.6% of the patients, it was lower than 17 kg/m². When evaluating using the NRS-2002 scale, 17.6% of the patients had 4 points and higher. The median of ASA grade was 3, while the ASA grade 4 was reported for 8.6% of the patients. The median comorbidity index was 3, but in 34% of observations it was higher than 5 points. Which is why the pre-operative preparation was arranged for 28.8% of the patients. In 21.8%, the correction of the nutritional insufficiency was done (6.2% — parenteral feeding, 3.8% — nasogastric tube, 5.2% — gastrostomy, 3.4% — esophageal bougienage, 0.8% — esophageal stenting, 6.2% — sipping). The invasive diagnostics and the correction of the concomitant cardio-vascular disease was needed in 7% of the patients (5.8% — coronary angiography, 1.6% — transcutaneous coronary intervention, 0.4% — installation of the permanent pacemaker, 0.4% — coronary artery bypass grafting, 0.2% — aortofemoral bypass, 0.2% — transcatheter implantation of the aortic valve, 0.4% — carotid endarterectomy).

All the patients underwent the sub/total EE, while in 2.6% it was combined with gastrectomy or subtotal proximal gastric resection. All the operations were carried out using the open transthoracic (44.6%) or transhiatal (55.4%) accesses with the formation of the manual cervical anastomosis. In 92.6% of the patients, the esophagoplasty was done using the gastric tube. During the esophagogastrectomy and in cases when the stomach was not usable, the esophagoplasty was done using the colon segment (6.2%). In case of the significant deficit in the length of the gastric tube (1.2%), the combined transplant was used. For this, the gastric tube was dissected from the duodenum, and resulting diastasis was replaced with the jejunal segment with the vascular pedicle. The median duration of surgery was 390 min.

From 2017, 97.4% of the patients were extubated in the operating room and transferred to the ICU for further follow-up. The median of stay at the ICU was 0.67 days. The program of early oral feeding included 96 (19.2%) patients. The median duration of the post-operative period was 9 POD.

Primary findings

Post-operative complications were developing in 29.2% of the patients. All the complications classified using the ECCG, are summarized in table 1. The most frequently diagnosed complications were the pulmonary ones (22.4%). Pneumonia was detected in 50 (10%) patients. The second most frequent were the gastro-intestinal (GI) complications in 39 (7.8%) patients. The most life-threatening complication was the subtotal necrosis of the transplant — 11 (2.2%) patients, ending with its extirpation and with the elimination of the esophago- and gastro-/jejunostomas. The apical necrosis of the transplant in 11 (2.2%) patients and the incompetence of the esophageal anastomosis in 11 (2.2%) were treated conservatively (tube feeding, draining of the wound, implantation of the vac-systems). The urological complications, mainly including the acute renal insufficiency, were reported in 35 (7%) patients. The majority of them were managed conservatively, but 10 (2%) patients were requiring the replacement renal therapy. The cardial complications were reported in 31 (6.2%) patients. They were more often manifesting as newly diagnosed atrial fibrillation, which was treated conservatively. Infectious complications were found in 9.6% of the patients, thromboembolic — in 3%, neurological — in 6.6%, wound-related — in 1.4%, other types — in 4.8% of the patients. The postoperative chylothorax was developing in 0.2% of observations.

 

Table 1 The results of EE with simultaneous plasty obtained at the NMRCS and compared to the Irish National Esophageal and Gastric Center, Esophageal Complications Consensus Group and Dutch Upper GI Cancer Audit group

Complication	NMRCS n=500 (%)	INC n=219 (%)	ECCG n=2704 (%)	DUCA n=1617 (%)
Total number of complications	146 (29.2)	118 (54)	1595 (59)	1046 (65)
Gastro-intestinal complications	39 (7.8)	25 (11.4)	606 (22.4)	392 (24.2)
Anastomosis failure/apical necrosis of the transplant	22 (4.4)	12 (5.4)	307 (11.4)	307 (19)
Sub-/total necrosis of the transplant	11 (2.2)	3 (1.3)	34 (1.3)	13 (1)
Intestinal obstruction, requiring intervention	2 (0.4)	1 (0.4)	46 (1.7)	12 (1)
Obstruction of the small intestine	0 (0)	3 (1.3)	12 (0.4)	4 (0.3)
Complications related to the feeding stoma	0 (0)	2 (0.9)	27 (1.0)	55 (3.4)
Complications related to the pylorotomy / pyloroplasty	0 (0)	1 (0.4)	5 (0.2)	6 (0.4)
Clostridium difficile-associated infection	0 (0)	1 (0.4)	23 (0.9)	2 (0.1)
Pancreatitis	5 (1)	2 (0.9)	8 (0.3)	3 (0.2)
Gastro-intestinal hemorrhage	0 (0)	0 (0)	21 (0.8)	1 (0.06)
Impaired functions of the liver	1 (0.2)	4 (1.8)	6 (0.2)	5 (0.3)
Gastrostasis, requiring the nasogastric decompression later than POD 7 or surgical intervention	0 (0)	0 (0)	180 (6.7)	7 (1.7)
Pulmonary complications	112 (22.4)	69 (31.5)	752 (27.8)	529 (32.7)
Pneumonia	50 (10)	40 (18.2)	396 (14.6)	341 (21.1)
Hydrothorax, requiring draining	83 (16.6)	33 (15.0)	267 (9.9)	124 (7.7)
Pneumothorax, requiring draining	27 (5.4)	2 (0.9)	91 (3.4)	68 (4.2)
Atelectasis, requiring the bronchoscopy	33 (6.6)	6 (2.7)	85 (3.1)	18 (1.1)
Respiratory insufficiency, re-intubation	18 (3.6)	22 (10)	189 (7.0)	84 (5.2)
Acute respiratory distress syndrome	5 (1)	6 (2.7)	50 (1.8)	24 (1.5)
Acute aspiration syndrome	7 (1.4)	3 (1.3)	27 (1.0)	25 (1.6)
Injury of the tracheobronchial tree	0 (0)	2 (0.9)	11 (0.4)	11 (0.7)
The pleural drainage persisting for over 10 POD	0 (0)	1 (0.4)	13 (0.5)	11 (0.7)
Cardiac	31 (6.2)	51 (23.3)	455 (16.8)	276 (17.1)
Cardiac arrest (CPR)	2 (0.4)	2 (0.9)	28 (1.0)	9 (0.6)
Myocardial infarction	0 (0)	1 (0.4)	15 (0.6)	5 (0.3)
Atrial arrhythmia, requiring treatment	29 (5.8)	50 (22.8)	393 (14.5)	224 (13.9)
Ventricular arrhythmia, requiring treatment	0 (0)	0 (0)	25 (0.9)	23 (1.4)
Congestive cardiac insufficiency, requiring treatment	2 (0.4)	1 (0.4)	12 (0.4)	17 (1.1)
Pericarditis, requiring treatment	0 (0)	1 (0.4)	2 (0.1)	3 (0.2)
Thromboembolic complications	15 (3)	5 (2.3)	141 (5.1)	45 (2.8)
Deep vein thrombosis	6 (1.2)	2 (0.9)	25 (0.9)	4 (0.2)
Thromboembolism of the pulmonary artery	6 (1.2)	2 (0.9)	33 (1.2)	35 (2.2)
Stroke	3 (0.6)	1 (0.4)	4 (0.1)	1 (0.06)
Thrombophlebitis of the peripheral veins	4 (0.8)	0 (0)	79 (2.9)	4 (0.25)
Urological complications	35 (7)	18 (8.2)	224 (8.3)	66 (4.1)
Acute renal failure	33 (6.6)	11 (5.0)	39 (1.4)	11 (0.7)
Acute renal failure, requiring the renal replacement therapy	10 (2)	6 (2.7)	24 (0.9)	5 (0.3)
Infection of urinary tracts	3 (0.6)	1 (0.4)	68 (2.5)	20 (1.2)
Acute urine retention, requiring the installation of the catheter	3 (0.6)	0 (0)	104 (3.8)	32 (2)
Infectious complications	48 (9.6)	28 (12.8)	383 (14.2)	120 (7.4)
Wound infection, requiring the open-access treatment or antibacterial therapy	5 (1)	9 (4.1)	20 (0.7)	37 (2.3)
Central catheter infection	6 (1.2)	6 (2.7)	55 (2.0)	10 (0.6)
Intrathoracic/abdominal abscess	10 (2)	5 (2.3)	65 (2.4)	37 (2.3)
Sepsis	15 (3)	12 (5)	52 (1.9)	17 (1.1)
Other infection, requiring the antibacterial therapy	20 (4)	6 (2.7)	227 (8.4)	20 (1.2)
Neurological/mental complications	33 (6.6)	28 (12.8)	254 (9.4)	172 (10.6)
Injury of the recurrent laryngeal nerve	19 (3.8)	7 (3.1)	114 (4.2)	70 (4.3)
Acute delirium	15 (3)	11 (5.0)	105 (3.9)	97 (6)
Alcoholic delirium	0 (0)	3 (1.3)	16 (0.6)	2 (0.1)
Other neurological traumas	6 (1.2)	0 (0)	33 (1.2)	10 (0.6)
Wound/diaphragmatic complications	7 (1.4)	3 (1.4)	78 (2.9)	30 (1.9)
Dehiscence of the thoracotomy wound	0 (0)	0 (0)	40 (1.5)	16 (1)
Eventration	7 (1.4)	2 (0.9)	33 (1.2)	7 (0.4)
Acute diaphragmatic herniation	0 (0)	1 (0.4)	8 (0.3)	7 (0.4)
Other complications	24 (4.8)	24 (11.0)	185 (6.8)	138 (8.5)
Chylothorax	1 (0.2)	12 (5.4)	128 (4.7)	139 (8.6)
Repeated surgery for the reasons other than gastro-intestinal hemorrhages, necrosis or conduit failure	18 (3.6)	7 (3.1)	39 (1.4)	17 (1.1)
Polyorgan insufficiency	8 (1.6)	4 (1.8)	27 (1.0)	2 (0.1)
Mortality	7 (1.4)	2 (0.9)	66 (2.4)	27 (1.7)

Note. NMRCS — the results from the National Medical Research Center of Surgery named after A.V. Vishnevsky; INC — the results from the Irish National Esophageal and Gastric Center; ECCG — the results from the Esophageal Complications Consensus Group; DUCA — the results from the Dutch Upper Gastrointestinal Cancer Audit.

 

In 92 (18.4%) patients, the complications were classified as grade I, II and IIIa acc. to the Clavien-Dindo classification. They were managed with medication treatment or with minimal surgical interventions (punction treatment of hydrothorax or pneumothorax). The complications in these groups were minimally affecting the course of the postoperative period. The grade III-b complications and higher were reported in 54 (10.8%) patients.

The fatal outcome was reported in 7 patients (1.4%):

1. The patient aged 23 years with a lengthy burn stricture of the esophagus has deceased on POD 14 after the transhiatal EE with simultaneous plasty using the gastric tube. The autopsy has revealed the acute insufficiency of the cerebral circulation of the ischemic type in the area of the right internal carotid artery.
2. The female patient aged 69 years with grade 4 achalasia of cardia has deceased on day 11 after the transhiatal EE with simultaneous plasty using the gastric tube. The autopsy has revealed the necrosis of the transplant and the thrombosis in the area of the celiac trunk and in the upper mesenteric artery.
3. The patient with esophageal cancer сТ4NxM1 aged 67 years after the transthoracic EE with simultaneous plasty with gastric tube has deceased on POD 3. The cause of death was the hepatic insufficiency with a background of hepatic cirrhosis and the massive intraoperative blood loss resulting from the severe portal hypertension.
4. The patient with esophageal cancer сТ2NxM0 and aged 69 years after the transthoracic EE with simultaneous plasty with gastric tube has deceased on POD 6. Due to the necrosis of the conduit, the acute respiratory distress-syndrome has developed along with the septic shock, leading to the fatal outcome.
5. The patient with esophageal cancer сТ4аNxM0 aged 89 years after the transhiatal EE with simultaneous plasty with gastric tube has deceased on POD 12 due to the aspiration pneumonia and due to the decompensation of cardiac failure.
6. The female patient aged 29 years with a lengthy burn stricture of the esophagus after the transthoracic esophagogastrectomy with simultaneous plasty using the colon segment has deceased on POD 8. The autopsy has revealed the non-occlusive mesenteric ischemia.
7. The patient with esophageal cancer сТ4аN2M0 and aged 85 years after the transhiatal EE with simultaneous plasty with gastric tube. On POD 5 at the specialized department, he had an episode of arrhythmogenic or hypoxic cardiac arrest. Long-term resuscitation activities have resulted in the development of the post-resuscitation disease and the vegetative status. Deceased on POD 55 due to the purulent-septic complications.

Undesirable phenomena

All the complications are summarized in table 1 and described in the sections containing the primary research outcomes.

DISCUSSION

The comparison of the results obtained by the RAPOR program to the findings from the global literature is difficult. All the authors within the ERAS framework were operating only the oncology patients and were mainly using the Lewis surgery from the open or the thoracolaparoscopic access. With this, in the NMRCS, only 46% of the patients had esophageal cancer. The other patients were operated due to the presence of benign diseases. Besides, all the surgeries were carried out using the open access. The results of using the ERAS for EE due to benign diseases of the esophagus were not found in the foreign literature. But, disregard from the ERAS, it was shown that this category of patients had higher rates of post-operative complications and longer duration of the postoperative period [11]. K.R. Shen et al. (2010) [12] have found that EE after the previous anti-reflux surgeries is associated with technical difficulties and higher complication rates (36.9% and 62.5%, respectively). Multiple bougienage of the cicatricially modified esophagus increased the severity of peri-esophagitis, by this encumbering the EE and increasing the risk of complications [13]. In 46.4% of the NMRCS patients, the past medical history had surgeries in the esophagus or stomach.

Despite the fact that ERAS is a strict protocol, all the centers have a various vision of it. It is mainly related to the fact the official ERAS recommendations for esophageal surgery were issued only in 2019 [7]. Thus, Y. Nevo [14] have compared the EE results obtained when using the traditional scheme of managing the patients to the results of the first EE within the framework of the ERAS issued in 2011 and to the results obtained within the framework of the upgraded protocol issued in 2019. The total rate of complications did not significantly differ and equaled 62%, 59% and 52%, respectively. However, the rate of post-operative pneumonia has statistically significantly decreased from 23% and 17% to 7% in 2019. A decrease was also found in the duration of hospitalization — from 10 to 7 POD. But all the variants of the protocol included the long-term use of the nasogastric tube (7, 3 and 2 POD, respectively) and of the pleural draining tube (7 and 6 POD), which did not correspond to the ERAS concept [14].

The rate of complications within the framework of the ERAS varies from 8.6% in the research by L. Chen et al. (2016) and 10.5% in the research by Z. Zhang et al. (2018) to 59.8% in the research by F. Klevebro et al. (2022) [15–17]. However, only the Irish center (INC, 2021) has published a detailed overview of the structure of the complications evaluated using the ECCG [18]. With this, the research works with a low rate of complications included only the somatically healthy patients (ASA I–II), and the pleural draining tube was retained until POD 3 [15, 16]. Also, a detailed review of the treatment results is provided in the multi-center Danish (DUCA — 1617 individuals) [19], in the pan-European (ECCG — 2704 individuals) [20] and in the American (9389 individuals) [21] research works. The rate of ECCG-rated complications was 63%, 59% and 64%, respectively. But the authors did not claim the use of ERAS-principles. There were no national publications found that reflect the treatment results obtained using the large patient samples.

After the EE, the most commonly developing complications are the pulmonary ones — 16.7% [22] – 32% [23] The first place among them belongs to the post-operative pneumonia — 0.77% [24] – 21.2% [25]. The second most often are the atrial rhythm disorders within the structure of the cardiac complications (16.8% [20] — 25% [19]). The most dangerous ones include the specific gastro-intestinal complications — the failure of esophageal anastomosis (2.9% [26] — 19%[19]) and the transplant necrosis (0.5% — 10.4%[27] ). Y. Akiyama et al. (2017) have published the data on the presence of anastomosis failure in the research including 33 patients, however, the patients were discharged on an average of POD 20 [25]. Oftentimes specifically the postoperative pneumonia, the anastomosis failure and the necrosis of the conduit define the duration of the post-operative period (7 [28] – 19.6 [25] POD) and the mortality (0.8% [29] – 4.5% [20]).

From our point of view, the most correct is the comparison of the results obtained at the NMRCS to the INC single-center research, conducted within the framework of the ERAS-protocol. The INC research included only the patients with ASA grade I–III esophageal cancer without the deficit of the body weight. All the patients have intraoperatively underwent the pyloroplasty with forming the jejunostoma for the initiation of enteral feeding from POD 1. The comparison also included the data from the multi-center research works ECCG and DUCA. The classification of the complications in all the research works was done by means of applying the unified ECCG register (see table 1).

What strikes the eye is the fact that the research based on the ERAS concept promotes to the decrease of the rate of anastomosis failure and of the apical necrosis of the conduit (4.4% for NMRCS and 5.4% for INC vs 11.4% for ECCG and 19% for DUCA). The higher rate of transplant necrosis in the NMRCS (2.2% vs 1–1.3% in other research works) is related to the formation of longer conduit for the subtotal esophageal replacement. The types of surgeries conducted at the NMRCS are the reason of the absence of post-operative gastrostasis characteristic for the Lewis surgery (6.7% ECCG). Through the application of the RAPOR program, the rate of post-operative pneumonia at the NMRCS is significantly lower than in the other centers (10% vs 18.2%, 14.6% and 21.1%). Besides, the cervical location of the conjunction, the small rate of anastomosis failure and of pneumonia have facilitated the rarity of atrial arrythmias (5.8% vs 22.8%, 14.5% and 13.9%) in particular and the cardiac complications in general (6.2% vs 23.3%, 16.8% and 17.1%). The relatively low rate of post-operative pneumonia, of rhythm disorders and of the anastomosis failure explains the low rate of acute delirium at the NMRCS (1.6% vs 5%, 3.8% and 6%). The mortality after EE within the framework of the RAPOR program was lower comparing to the one observed in the multi-center research works (1.4% for NMRCS and 0.9% for INC vs 2.4% for ECCG and 1.7% for DUCA).

The implementation of the RAPOR program began in 2012. During the consecutive 12 years, its gradual evolution and modification followed based on the obtained clinical experience and on the new scientific data. Then followed the refusal to perform the draining of the neck wound, to install 2–3 draining tubes into the abdominal cavity, to perform the nasogastric decompression, to arrange the prolonged artificial pulmonary ventilation, to use the polypharmacy or long-term postoperative fasting. The intraoperative infusion therapy from the liberal one first became closer to the restrictive one, and then became the purpose-oriented one. The protocols were formulated for the nutritional therapy within the pre- and the post-operative periods, with implementing the early oral feeding. This affected the results of treating the patients and the absence of fatal outcomes during the period of 2021–24.

Our RAPOR program is based on the individual, the team-based and the interdisciplinary approach to each patient. For every patient, a personal management and preparation program is being compiled based on the patient’s age, on the physical, the somatic, the nutritive and the psychological status. Through this, at the premises of the NMRCS, it became possible to safely treat the aged and the comorbid patients. Among the 500 patients, the Charlson index value higher than 7 was reported for 12.2%, the ASA grade IV physical status was reported for 8.6%, while 12.8% of the patients were older than 70 years. Out of the whole variety of post-operative management elements in the RAPOR program, we select only the ones which are applicable in the clinical situation of the specific patient. The main attention in the program we have paid to the preoperative preparation of the patient and to the correction of all the modifiable risk factors (cardio-vascular diseases, nutritional status etc.). This preparation was required by 27.8% of the patients.

From our point of view, the main principle of the RAPOR program is the priority of the program over the protocol. Despite the fact that the ERAS elements form the basis of the RAPOR program as the POM elements, its main difference is the flexibility and the absence of the protocol-based approach. There are data stating that the implementation of the ERAS-protocol improves the results of treating the patients only in case of its implementation by more than 70%. But the compliance to the protocol significantly decreases among the comorbid patients and in cases of open-access interventions [30]. The prospective research by F. Puccetti et al. (2022) has also revealed that during the first 48 hours of treatment, the compliance to the protocols remains high (82.7%) with its further significant decrease due to the development of complications [28]. The survey research by S. Salvans et al. (2023) has revealed that the percentage of protocol compliance worldwide principally remains low [31]. Developing the omni-purpose protocol for the extremely heterogeneous groups of patients is impossible. This is why it is better to move either towards the personalization of treatment and to the compilation of the flexible POM program, but not to the protocol and to the standardization of the patients. With this, the implementation of the specific anesthesiology, resuscitation and rehabilitation elements takes place in accordance with the protocol for each of the elements, but within the framework of the flexible general program.

Personalized treatment is the second principle of the RAPOR program. The standard POM/ERAS/RAPOR elements (omitting the fasting phase and the preparation of the intestine, normothermia, normovolemia, protective pulmonary ventilation etc.) are applicable when combined in a statically average patient. But in the aged or comorbid patients, they are accompanied by the specialized treatment methods, proceeding from the available risk factors for postoperative complications and from the mortality or from the already developing complications. With this, omitting one or several standard elements does not mean skipping the program compliance.

The third principle of the RAPOR program is compiling an interdisciplinary team, which is involved in managing the patient during the whole perioperative period. The bases of the ERAS-concept bear the compilation of the multidisciplinary team, the main participants of which are surgeons, anesthesiologists, nurses, nutritionists, physiotherapists and specialized physicians. In the extended versions, the team may be supplemented with the social service workers, the clinical pharmacists, the administrators, the statisticians for monitoring the results and the specialists in the fields of information technologies for managing the digital flow [32]. The multidisciplinary team is a large group of people, in which every member provides his own recommendations for the treatment of the patient. The literature contains no research work criticizing this type of the team. But, in the settings of the multidisciplinary approach, each field still remains within its frames, and the specialists operate in parallel and independently from each other in a flow of patients. Upon the interdisciplinary approach, a closer interaction is applicable with lesser number of specialists, along with the profound integration of the professional knowledge between the team members and their active communication with the daily discussion of the patient management plans. The members of the interdisciplinary team (the surgeons, the anesthesiologist, the intensivist and the nurses) operated altogether in a single department. One and the same surgeon and intensivist manage the patient during the pre- and the post-operative periods (including the pre-hospital phase, the Resuscitation and Intensive Care Department and the specialized department), and in the operating room, a single anesthesiologist is working.

The implementation of the RAPOR program has allowed for refusing from the criteria for selecting the patients with moving on to the evaluation of the risks of complications and their correction. Eventually, a decrease was achieved in the number of refuses to perform the surgical intervention due to the age or the severity of the concomitant diseases.

Research limitations

The application of the RAPOR program is only possible in the high-flow specialized department of esophageal and gastric surgery.

CONCLUSION

Esophagectomy with simultaneous esophagoplasty is a surgery that is accompanied by high rates of complications. Omitting the strict protocol in favor of the flexible RAPOR program, developed at the NMRCS, has allowed for successfully operating even the high-risk aged and comorbid patients. With this, the mortality, the rate of complications in general and of the life-threatening complications (pneumonia, necrosis of the conduit, anastomosis failure) in particular are less then the global rates. The individual team-based interdisciplinary approach together with the high-quality surgical aid serve as the basis of managing the high-risk surgeries.

ADDITIONAL INFORMATION

Author contributions: N.B. Kovalerova, treatment of patients, data collection, writing the text of the article; D.V. Ruchkin, the operator of all surgical interventions, management of patient treatment and discussion of the results of the study, O.V. Strunin, V.A. Kozlov search and analytical work, discussion of the results of the study. Thereby, all authors provided approval of the version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Ethics approval: The organization of the study was approved by the local Ethics Committee of the Vishnevsky National Medical Research Center for Surgery of the Ministry of Health of the Russian Federation (Protocol No. 007-2024 dated 2024 Oct 25). All study participants signed an informed consent form before being included in the study.

Funding sources: The study was carried out without attracting external funding.

Disclosure of interests: The authors declare no conflict of interests.

Statement of originality: The authors did not utilize previously published information (text, illustrations, data) in conducting the research and creating this paper.

Data availability statement: The editorial policy regarding data sharing does not apply to this work, data can be published as open access.

Generative AI: Generative AI technologies were not used for this article creation.

About the authors

Dmitry V. Ruchkin

A.V. Vishnevsky National Medical Research Center of Surgery; Russian Medical Academy of Continuous Professional Education

Email: ruchkindmitry@gmail.com
ORCID iD: 0000-0001-9068-3922
SPIN-code: 2587-8568
Scopus Author ID: 7003463000

MD, PhD

Russian Federation, Moscow; Moscow

Natalia B. Kovalerova

A.V. Vishnevsky National Medical Research Center of Surgery

Author for correspondence.
Email: kovalerova.nat@gmail.com
ORCID iD: 0000-0002-6951-1816
SPIN-code: 2525-9338

MD, PhD

Russian Federation, Moscow

Oleg V. Strunin

A.V. Vishnevsky National Medical Research Center of Surgery; Peoples’ Friendship University of Russia

Email: struninov@mail.ru
ORCID iD: 0000-0003-2537-954X
SPIN-code: 4734-0837

MD, PhD

Russian Federation, Moscow; Moscow

Valentin Aleksandrovich Kozlov

A.V. Vishnevsky National Medical Research Center of Surgery

Email: kozipan@mail.ru
ORCID iD: 0000-0002-4926-116X
SPIN-code: 5917-6510

MD, PhD

Russian Federation, Moscow

References

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