Published online Nov 27, 2026. doi: 10.4240/wjgs.124340
Revised: July 15, 2026
Accepted: September 4, 2026
Published online: November 27, 2026
Processing time: 153 Days and 14.1 Hours
Ivor Lewis esophagectomy is the standard surgical approach for middle and distal esophageal cancer. Despite advances in minimally invasive techniques and perioperative care, anastomotic leakage (AL) remains a major cause of posto
To evaluate the feasibility, safety, and preliminary clinical outcomes of a modi
This retrospective single-center study included 31 patients who underwent Ivor Lewis esophagectomy from July 2019 to June 2024. Sixteen patients received prophylactic ModVAC therapy, while fifteen earlier patients served as historical controls. The primary outcome was AL.
Baseline characteristics were comparable between groups. AL occurred in 25% vs 40% of patients (P = 0.37), with all ModVAC leaks managed non-operatively. Hospital stay, morbidity, and mortality were similar. Protocol completion was 81.25% with minimal device-related complications.
Prophylactic ModVAC is a feasible and safe adjunct following Ivor Lewis esophagectomy. Although leak reduction was not statistically significant, the favorable management of leaks suggests potential clinical benefit. Larger prospective randomized studies are warranted.
Core Tip: Anastomotic leakage remains one of the most serious complications after Ivor Lewis esophagectomy. This study presents the first clinical experience with a modified, endoscopy-independent prophylactic vacuum-assisted closure system (ModVAC) that can be placed intraoperatively using standard surgical materials. ModVAC was feasible, safe, and achieved a high protocol completion rate with minimal device-related complications. Although the reduction in anastomotic leakage did not reach statistical significance in this preliminary cohort, all leaks in the ModVAC group were managed non-operatively, supporting further evaluation of this simple, low-cost prophylactic approach in larger prospective studies.
- Citation: Ciciboga K, Uprak TK, Ermerak NO. Prophylactic application of modified vacuum-assisted closure therapy in Ivor Lewis esophagectomy: Preliminary results. World J Gastrointest Surg 2026; 18(11): 124340
- URL: https://www.wjgnet.com/1948-9366/full/v18/i11/124340.htm
- DOI: https://dx.doi.org/10.4240/wjgs.124340
Ivor Lewis esophagectomy remains one of the most widely adopted surgical approaches for mid- and distal esophageal malignancies. Despite advances in minimally invasive and hybrid techniques, enhanced perioperative care, and impro
Endoluminal vacuum therapy (EVT) has recently emerged as an effective minimally invasive treatment for esophageal leaks, offering better closure rates, shorter treatment times, and lower mortality compared to stenting[4]. Continuous negative pressure promotes drainage, reduces edema, and improves tissue perfusion. Building on these benefits, prophylactic EVT has been proposed for high-risk patients to prevent anastomotic leaks, with early studies suggesting improved oxygenation and reduced ischemia at the anastomotic site[5]. However, clinical evidence supporting routine prophylactic use remains limited.
In this study, we evaluated the clinical feasibility and potential efficacy of a modified, endoscopy-independent prophylactic vacuum-assisted closure system (ModVAC) in patients undergoing esophagectomy for malignancy. Unlike conventional EVT systems, ModVAC was developed as a sponge-free adaptation compatible with negative pressure principles, enabling insertion through a nasogastric route without the need for endoscopy. Additionally, the system was constructed using routinely available hospital materials, significantly reducing procedural cost. This study presents the preliminary results on the use of ModVAC in Ivor Lewis esophagectomy, focusing on its impact on anastomotic leak rates and its feasibility in routine clinical practice. Additionally, early observations regarding its role in the management of established anastomotic leaks and its potential to improve postoperative outcomes and reduce associated morbidity are reported.
This retrospective observational study was conducted at the General Surgery Clinic of Marmara University Pendik Training and Research Hospital. We included patients who underwent Ivor Lewis esophagectomy for esophageal cancer from July 2019 to June 2024.
Ethical approval was obtained from the Marmara University Faculty of Medicine Clinical Research Ethics Committee (Approval No. 09.2024.610). All patient data were retrospectively collected and analyzed.
The study included patients who underwent curative Ivor Lewis esophagectomy. Exclusion criteria were loss to follow-up, insufficient postoperative data, palliative or stage IV resections, and contraindications to nasogastric drainage. Patients were excluded if they were lost to follow-up or lacked sufficient postoperative data, if they underwent palliative or stage IV resections, if nasogastric drainage was contraindicated, or if they declined participation in the study.
Data were retrieved retrospectively from hospital electronic medical records and included demographic characteristics such as age, sex, and body mass index, as well as comorbidities and the American Society of Anesthesiologists (ASA) physical status classification. Surgical details encompassed the type of esophagectomy, the anastomotic technique used, and reconstruction method. Postoperative outcomes included morbidity, mortality, length of hospital and intensive care unit stay, and complications, which were categorized according to the Clavien-Dindo classification. Information regarding AL management and patient outcomes was collected.
Intrathoracic esophagogastrostomy was performed in all patients. The anastomosis was routinely reinforced with an omental flap. Standard postoperative management included placement of a right-sided chest tube and a Jackson-Pratt drain adjacent to the anastomosis. In patients with significant preoperative weight loss (> 10%) or evidence of malnutrition, a feeding jejunostomy was established intraoperatively.
Following its introduction in December 2022, prophylactic ModVAC therapy became part of the routine institutional protocol for patients undergoing Ivor Lewis esophagectomy. Consequently, patient allocation was determined by the timing of surgery rather than by patient characteristics, surgical approach, or intraoperative findings.
The ModVAC system was designed to replicate the drainage function of conventional sponge-based vacuum-assisted closure (VAC) systems without requiring endoscopic placement. The overall configuration of ModVAC device is shown in Figure 1. The device consists of a 10-Fr feeding tube inserted through the lumen of an 18-Fr nasogastric tube, with multiple perforations created along the distal 3 cm of the inner tube using an 18-gauge needle to facilitate effective drainage and improved oxygenation at the anastomotic site. The assembly and preparation of the ModVAC system are illustrated in Figure 2.
Immediately following completion of the anastomosis, the ModVAC system was introduced transnasally and carefully positioned so that the perforated distal segment rested at the anastomotic level. The external portion of the device was secured to the nostril to prevent displacement and connected to a vacuum pump delivering continuous negative pressure set at 10.0 kPa (75 mmHg). Postoperative checks were performed at 3 and 12 hours to verify system patency, and in cases of blockage, irrigation with sterile saline was applied to restore function.
During the ModVAC treatment period, patients were maintained nil per os and supported with intravenous fluids and nutritional supplementation as necessary. Patients without a feeding jejunostomy were managed with intravenous fluid therapy during this period and did not receive additional enteral or parenteral nutritional support. The ModVAC system was maintained until postoperative day four. Routine endoscopic evaluation before ModVAC removal was not performed. On the fourth postoperative day, a leak test was performed either by administering methylene blue or via contrast-enhanced thoracoabdominal computed tomography. In the absence of detected leakage, the ModVAC device was removed on postoperative day five, and oral feeding was gradually initiated. Patients without a feeding jejunostomy who developed a confirmed anastomotic leak received parenteral nutritional support until definitive management of the leak permitted enteral feeding.
Postoperative monitoring included daily clinical assessment of vital signs and measurement of inflammatory markers such as C-reactive protein and white blood cell count. Drain output was recorded, noting volume and macroscopic appearance. If clinical suspicion of anastomotic leak arose, based on findings such as fever, tachycardia, elevated inflammatory markers, respiratory deterioration, or abnormal drain output (e.g., saliva or bile), further evaluation with contrast-enhanced computed tomography and endoscopy was performed[1]. Leak management strategies were tailored according to defect size, with small leaks managed conservatively through chest tube drainage, and larger defects treated by stenting or repeat application of ModVAC therapy.
The primary outcome of interest was the incidence of AL following prophylactic ModVAC therapy. Secondary outcomes included overall postoperative morbidity and mortality rates, length of hospital and intensive care stay, as well as the feasibility and safety profile of the ModVAC protocol. Parameters related to device performance, including drainage volume, duration of therapy, and treatment-associated complications, were also recorded and analyzed.
Statistical analyses were performed with Jamovi 2.5.6. Continuous data are presented as the mean ± SD or median (interquartile range) based on normality. Categorical data are shown as n (%). Group comparisons used t-test or Mann-Whitney U for continuous variables and χ2 or Fisher’s exact test for categorical variables. P < 0.05 was considered statistically significant.
From July 2019 to June 2024, a total of 31 patients undergoing Ivor Lewis esophagectomy for esophageal malignancy at Marmara University Pendik Training and Research Hospital were retrospectively analyzed. Patients who underwent McKeown procedures, transhiatal resection, or palliative resections were excluded. Of these, 16 patients received ModVAC therapy routinely from December 2022 onwards, while 15 patients did not. Patient demographics and baseline clinical characteristics are summarized in Table 1. The groups were comparable in terms of age (mean age 61 years vs 57 years; P = 0.80), sex distribution, ASA scores, and comorbidities including diabetes mellitus, coronary artery disease, and chronic obstructive pulmonary disease. No significant differences were observed in pathological diagnoses or receipt of neoadjuvant therapy (P > 0.05).
| Total (n = 31) | ModVAC (n = 16) | No-ModVAC (n = 15) | P value | |
| Sex | ||||
| Male | 19 (64.5) | 10 (62.5) | 10 (66.7) | |
| Female | 11 (35.5) | 6 (37.5) | 5 (33.3) | 0.801 |
| Age (mean) | 59 | 61 | 57 | 0.332 |
| Comorbidities | ||||
| DM | 7 (23.3) | 5 (33.3) | 2 (13.3) | 0.191 |
| CAD | 7 (23.3) | 3 (20) | 4 (26.7) | 0.661 |
| Smoking | 21 (70) | 10 (66.7) | 11 (73.3) | 0.691 |
| ASA score | ||||
| 2 | 26 (83.8) | 14 (87.5) | 12 (80) | |
| 3 | 5 (16.2) | 2 (12.5) | 3 (20) | 0.593 |
| Pathology | ||||
| Adenocarcinoma | 15 (48.4) | 9 (56.3) | 6 (40) | |
| SCC | 14 (45.2) | 6 (37.5) | 8 (53.3) | |
| Benign | 2 (6.5) | 1 (6.3) | 1 (6.7) | 0.651 |
| Tumor location | ||||
| Middle | 2 (6.5) | 0 | 2 (13.3) | |
| Distal | 21 (67.7) | 11 (68.6) | 10 (66.7) | |
| GEJ | 8 (25.8) | 5 (31.3) | 3 (20) | 0.221 |
| Neoadjuvant therapy | ||||
| No | 12 (38.7) | 5 (31.3) | 7 (46.7) | |
| Yes | 19 (61.3) | 11 (68.8) | 8 (53.3) | 0.371 |
The mean duration of ModVAC therapy was 4.3 days (range 2-11), with a mean aspirated fluid volume of 489 mL contai
| Maximum | Minimum | Mean | |
| Aspirated fluid, mL | 1800 | 0 | 489 |
| Duration of application, days | 11 | 2 | 4.3 |
| Length of hospital stay, days | 56 | 7 | 20.4 |
Surgical approaches were categorized into minimally invasive, open, hybrid (laparotomy with video-assisted thoracoscopic surgery or laparoscopy with thoracotomy), and transhiatal resections. Surgical approach, anastomotic techniques, and clinical outcomes are summarized in Table 3. The ModVAC group had a higher proportion of minimally invasive procedures (43.8% vs 6.7%; P = 0.01), while open surgery was more frequent in the non-ModVAC group (66.7% vs 12.5%). Anastomotic techniques included linear stapler, circular stapler, and hand-sewn methods. Circular stapler anastomoses predominated in the ModVAC group (62.5%), whereas hand-sewn anastomoses were more common in the non-ModVAC group (33.3%) (P = 0.02). Jejunostomy placement rates did not differ significantly (P = 0.85).
| Total (n = 31) | ModVAC (n = 16) | No-ModVAC (n = 15) | P value | |
| Operation type | ||||
| Minimally invasive | 8 (25.8) | 7 (43.8) | 1 (6.7) | |
| Open | 13 (41.9) | 3 (18.8) | 10 (66.7) | |
| Hybrid | 10 (32.3) | 6 (37.5) | 4 (26.7) | 0.011 |
| Anastomosis | ||||
| Linear stapler | 12 (38.7) | 6 (37.5) | 6 (40) | |
| Circular stapler | 14 (45.2) | 10 (62.5) | 4 (26.7) | |
| Hand sewn | 5 (16.1) | 0 | 5 (33.3) | 0.021 |
| Jejunostomy | 15 (48.4) | 8 (50) | 7 (46.7) | 0.851 |
| Postoperative length of stay (mean days) | 20.8 | 20.4 | 21.3 | 0.882 |
| Anastomotic leak | ||||
| Absent | 21 (67.7) | 12 (75) | 9 (60) | |
| Present | 10 (32.3) | 4 (25) | 6 (40) | 0.371 |
| Clavien-Dindo | ||||
| Grade I-IIIa | 10 (62.5) | 6 (66.7) | 4 (57.1) | |
| Grade IIIb-IV | 6 (37.5) | 3 (33.3) | 3 (42.9) | 0.691 |
Postoperative clinical outcomes are summarized in Table 3. The average hospital stay was 20.4 days for the ModVAC group and 21.3 days for the non-ModVAC group (P = 0.88). Intensive care unit stay was longer in the ModVAC group (mean 13 days vs 7 days; P = 0.04). No significant difference in overall morbidity classified by Clavien-Dindo grades was observed between groups (P = 0.69). There were no mortalities reported in either group.
Anastomotic leak incidence and management outcomes are summarized in Table 3. Anastomotic leaks occurred in 25% of patients receiving ModVAC and 40% of those without ModVAC, although this difference was not statistically significant (P = 0.37). In the non-ModVAC group (n = 6), one patient required reoperation, while the remaining patients were managed with endoscopic interventions, including endoscopic vacuum therapy combined with stenting, stenting alone, or endoscopic clipping. In contrast, all patients in the ModVAC group (n = 4) were managed non-operatively, using combinations of endoscopic vacuum therapy and stenting, or, in one case, prolonged ModVAC application for up to 10 days. All patients in both groups underwent adequate drainage via chest tube or percutaneous methods, combined with antibiotic therapy.
The present study demonstrates that prophylactic application of a ModVAC is technically feasible and clinically safe in patients undergoing Ivor Lewis esophagectomy for esophageal malignancy. Although the observed reduction in AL rates -25% in the ModVAC group vs 40% in controls did not reach statistical significance, the numerical trend is consistent with the mechanistic rationale underlying negative pressure therapy and aligns with the emerging body of evidence supporting prophylactic endoluminal vacuum strategies in high-risk esophageal anastomoses. Crucially, no anastomotic leak in the ModVAC cohort required operative re-intervention, in contrast to the control group, suggesting that even in cases where leakage occurred, ModVAC may have attenuated the severity of the anastomotic defect and facilitated a more favorable clinical course amenable to non-operative management.
Unlike conventional sponge-based VAC systems, which often require endoscopic placement and are associated with higher costs, the ModVAC system was designed as a simple, sponge-free, prophylactic drainage system using readily available hospital materials[5]. Its tube-in-tube design enabled intraoperative placement via the nasogastric route and removal without additional endoscopic procedures, thereby simplifying the technique and reducing overall cost. Unlike conventional sponge-based EVT, which is primarily intended for the treatment of established anastomotic leaks and may promote greater granulation tissue formation due to its larger contact surface, ModVAC was developed to provide continuous drainage of saliva, refluxed gastrointestinal contents, and secretions around an intact anastomosis during the early postoperative period[5]. Although triple-lumen systems that allow simultaneous negative-pressure drainage and enteral nutrition may represent an attractive alternative, comparative studies are required to determine the optimal prophylactic negative-pressure system.
Drawing upon prior experimental study from Neumann et al[6], we limited the application of ModVAC to four postoperative days. This duration aimed to support healing without delaying oral intake or increasing stricture risk[7]. Unlike conventional EVT used for established anastomotic leaks, ModVAC was applied prophylactically around an intact anastomosis. Therefore, a continuous negative pressure of 10.0 kPa was selected to achieve effective drainage while minimizing mechanical stress on the newly created anastomosis, consistent with both our institutional experience and evidence from the literature on anastomotic leak management. The optimal negative-pressure setting for prophylactic applications remains to be determined in future comparative studies[5].
Treatment adherence was high, with 81.25% of patients completing the full 4-day ModVAC course; non-adherence in the remainder was primarily due to discomfort related to the drainage system or delirium-associated self-removal of drains in intensive care settings. The system effectively aspirated a mean volume of approximately 489 mL of gastric contents, bile, and debris, consistent with Müller et al’s observation[8] that removing such secretions may protect the anastomotic site from autodigestion and decrease the risk of aspiration pneumonia. These findings suggest that ModVAC may reduce mechanical and chemical stress on the anastomosis and mitigate conduit distension secondary to delayed gastric emptying[9]. Overall, ModVAC therapy was feasible to implement in routine clinical practice, with high patient adherence.
While endoscopic assessment of anastomotic healing is commonly performed in VAC therapy before therapy cessation, our protocol relied on clinical leak tests using oral methylene blue or contrast-enhanced computed tomography imaging[8]. Notably, no complications typically associated with EVT, such as bleeding, fistula formation, or air leaks, were observed[10]. Hospital stay durations did not differ significantly between ModVAC and control groups, further supporting the protocol’s safety and tolerability[10].
An unexpected finding of this study was the longer intensive care unit stay observed in the ModVAC group. Given the retrospective design, limited sample size, and historical comparison between study groups, this difference should be interpreted with caution and cannot be attributed directly to prophylactic ModVAC therapy. Differences in perioperative management, intensive care unit discharge practices, or unmeasured confounding factors may have contributed to this finding.
Prophylactic VAC use after esophagectomy is an emerging modality, with limited adoption worldwide. Consistent with Müller et al[8] and Gubler et al[11], our leak rates tended to be lower in the ModVAC group (25%) compared to controls (40%), although statistical significance was not reached, likely due to small sample size. The relatively high anastomotic leak rate observed in our study compared with the literature may be explained by the small sample size and the more frequent use of oral contrast-enhanced computed tomography, which facilitated the detection of clinically silent or minor radiological leaks that might have remained unrecognized in other series. Furthermore, our institution is a tertiary referral center managing complex esophageal cancer cases. Importantly, most detected leaks were not clinically significant, and no leak-related mortality occurred, suggesting that early diagnosis and prompt management reduced the clinical impact of these events[12].
Although anastomotic leaks still occurred despite the use of ModVAC, all cases in this cohort were successfully managed with non-operative strategies, suggesting a more controlled clinical course that could be effectively managed with endoscopic treatment. In contrast, one patient in the non-ModVAC group required reoperation[13].
This observation may indicate that ModVAC facilitates earlier and more controlled management of leaks, potentially by reducing exposure of the anastomotic site to gastric contents, saliva, and bile, thereby limiting progression. Furthermore, in one patient, leak resolution was achieved with prolonged ModVAC therapy alone, supporting its potential role as a standalone treatment modality in selected cases.
Our findings align with emerging evidence indicating that prophylactic EVT, while not completely preventing anastomotic leaks, may attenuate their clinical severity. Studies by Neumann et al[6], Müller et al[8], and Gubler et al[11] similarly suggest that early endoscopic stabilization enhances local healing and may limit leak progression.
Risk stratification in prior studies, such as those by Müller et al[8] and Chon et al[14], influenced patient selection for prophylactic VAC, often targeting those with advanced age, elevated ASA scores, or higher body mass index. Our groups did not differ significantly in these baseline characteristics.
A notable case in our cohort involved a patient with a positive intraoperative leak test after linear stapled anastomosis who underwent suture reinforcement and omental patching, followed by ModVAC therapy, resulting in successful healing without leak development. This case supports the hypothesis that ModVAC promotes angiogenesis and granulation of tissue formation, enhancing anastomotic repair.
This study is limited by its single-center retrospective design and relatively small sample size, restricting generalizability. In addition, long-term outcomes such as anastomotic stricture formation were not assessed, with the focus placed on feasibility and early postoperative results. The non-concurrent control design introduces potential temporal confounding, as patients in the control group were treated before December 2022, whereas the ModVAC group was treated thereafter. Evolving surgical approaches and perioperative care may therefore have influenced outcomes independently of the intervention.
The higher proportion of minimally invasive procedures and circular stapled anastomoses in the ModVAC group likely reflects institutional evolution rather than true comparability. Although advanced statistical methods could mitigate these confounders, their application was limited by sample size. The imbalance in surgical approach between the study groups reflects the chronological implementation of the ModVAC protocol rather than patient selection.
Since ModVAC was introduced as a routine practice in December 2022, most patients who underwent surgery before this date constituted the control group, during which open procedures were more common. This temporal imbalance should be considered when interpreting the results. Accordingly, these findings should be considered exploratory and hypothesis-generating. Larger prospective, ideally randomized studies with longer follow-up are required to validate these preliminary observations and optimize patient selection.
AL continues to represent a challenging complication following esophageal surgery, and optimal preventive strategies remain a subject of ongoing investigation. In this study, we assessed the feasibility of a prophylactic vacuum therapy approach using a modified, low-cost system (ModVAC) that can be applied without endoscopic guidance. The technique was generally well tolerated and was not associated with major adverse events. Although a lower incidence of AL was observed in patients receiving ModVAC compared with controls, these findings should be interpreted cautiously. Nonetheless, the results suggest that prophylactic negative pressure therapy may offer a protective effect at the anastomotic site and could represent a promising adjunctive strategy. Further prospective studies with larger cohorts are warranted to better define its efficacy and role in clinical practice.
The authors would like to express their sincere gratitude to their families for their continuous support. We also thank Professor Tevfik Kıvılcım Uprak and Professor Nezih Onur Ermerak for their valuable guidance in study planning and their contributions to the surgical management of the included cases.
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