Management of Colorectal Anastomotic Leaks With Endoluminal Vacuum Therapy: A Pragmatic Summary of the Evidence and Definition of Clinical Practices for Patient Selection, Technique, and Follow-up.

Background:Endoluminal vacuum therapy has been experimentally used in patients with esophageal, rectal, and Roux-en-Y bypass surgery. Yorkshire pigs are good animal models for studying the safety and efficacy of endoluminal vacuum therapy and prior studies have employed these devices in rectal anastomotic defects, as rescue therapy for early anastomotic leaks, as well as prophylactic therapy as a means of protecting high risk anastomosis.Aim:The objective of this study is to assess the effects of a prophylactic vacuum assist device on bowel tissue surrounding an intact anastomosis at 30 days post device removal.Methods:A total of seven pigs underwent a rectal resection with primary anastomosis: five experimental pigs with a prophylactic endoluminal vacuum device in place for 5 days post-surgery and two control pigs with no device. All animals were euthanized on the 35th post-operative day and subjected to a necropsy with a histopathological evaluation of the rectal anastomosis.Results:No significant difference in inflammation or strictures was observed between the anastomosis of animals with the endoluminal vacuum devices and controls.Conclusion:We, therefore, conclude that endoluminal vacuum therapy is safe for prophylactic use in pigs undergoing low anterior resection and does not cause significant strictures.Relevance for Patients:Anastomotic leak is a feared complication resulting in increased costs, length of stay, and emotional distress. Endoluminal negative pressure vacuum therapy is a new technology that has been used in experimental models in both animals and humans for prevention and treatment of anastomotic leak. In this series we demonstrate endoluminal vacuum therapy is safe in a porcine model and does not result in stricture or increased adhesion formation. We expect endoluminal vacuum therapy to become more widely used in the future in both prevention and treatment of anastomotic leaks.

Background: To investigate the efficacy of primary and rescue endoluminal vacuum (EVAC) therapy in the treatment of esophageal perforations and leaks.Methods: We conducted a retrospective review of a prospectively gathered, Institutional Review Board (IRB) approved database of EVAC therapy patients at our center from July 2013 to September 2016.Results: In all, 13 patients were treated for esophageal perforations or leaks. Etiologies included iatrogenic injury (n = 8), anastomotic leak (n = 2), Boerhaave syndrome (n = 1), and bronchoesophageal fistula (n = 2). In total, 10 patients underwent primary treatment and three were treated with rescue therapy. Mean Perforation Severity Scores (PSSs) in the primary and rescue treatment groups were 7 and 10, respectively. Average defect size was 2.4 (range: 0.5–6) cm. The rescue group had a shorter mean time to defect closure (25 vs. 33 days). In all, 12 of 13 defects healed. One death occurred following the implementation of comfort care. One therapy-specific complication occurred. Hospital length of stay (LOS) was longer in the rescue group (72 vs. 53 days); however, the intensive care unit (ICU) duration was similar between groups. Totally, 10 patients (83%) resumed an oral diet after successful defect closure.Conclusion: Utilized as either a primary or rescue therapy, EVAC therapy appears to be beneficial in the management of esophageal perforations or leaks.

Background Anastomotic leaks and perforations of the upper gastrointestinal (UGI) tract are life-threatening conditions which result in significant rates of morbidity. There is no consensus with respect to how these challenging cases should be optimally managed. Endoluminal vacuum therapy (EVT) is a novel approach for the management of leaks and perforations in the UGI tract. Proponents highlight the benefits of its use particularly in cases where major invasive surgery or re-operation would otherwise usually be required. We present the outcomes from nearly 450 EVT related procedures during the last 5 years. Methods A retrospective analysis of all UGI leaks and perforations managed with EVT between September 2018 and June 2023 was undertaken. This included patients who had undergone cancer resections (oesophagectomy and gastrectomy), bariatric surgery (both within and out with our centre) and those presenting with benign disease (e.g. oesophageal perforation and iatrogenic injury). The setting was a regional tertiary oesophago-gastric and bariatric centre in the North-West of England serving a population of over 3.5 million people. Demographic data, patient and disease factors, nutrition-related data, and outcomes related to EVT were collected. Descriptive and statistical analysis was undertaken. Results 59 patients (43 males; median age 61) underwent 446 EVT related procedures during the study period, of which 52 (88%) were alive at discharge. Median LOS was 43 days. 66% (39/59) cases related to post-operative leak (resection 28, bariatric surgery 11) vs 11/59 spontaneous and 8/59 iatrogenic perforations. Median number of procedures was 6 (IQR 3-11) over a median of 21 days (IQR 11-41). Successful healing was achieved in 86% (51/59) cases. There was no difference in success rate between pathologies (p=0.88), however, iatrogenic perforations required fewer EVT procedures before healing (p=0.00). No adverse events were directly attributable to EVT. Conclusions UGI leaks and perforations represent a heterogeneous group which pose a significant management challenge. Our study suggests that EVT is a safe and effective approach in managing a broad range of different UGI leaks and perforations. EVT opens the possibility of active treatment for patients unsuitable for more invasive surgical intervention. Further study is required to standardise nomenclature, indications and follow-up. Comparisons to other management approaches are required to further explore the benefits for patients, taking into consideration clinical efficacy, impacts on quality of life and cost-effectiveness.

Perforations and anastomotic leaks of the gastrointestinal tract are severe complications, which carry high morbidity and mortality and management of these is a multi-disciplinary challenge. The use of endoluminal vacuum (EVAC) therapy has recently proven to be a useful technique to manage these complications. We report our institution's experience with this novel technique in the chest, abdomen, and pelvis. This is a retrospective review of an IRB approved registry of all EVAC therapy patients from July 2013 to December 2016. A total of 55 patients were examined and 49 patients were eligible for inclusion: 15 esophageal, 21 gastric, 3 small bowel, and 10 colorectal defects. The primary endpoint was closure rate of the GI tract defect with EVAC therapy. Fifteen (100%) esophageal defects closed with EVAC therapy. Mean duration of therapy was 27 days consisting of an average of 6 endosponge changes every 4.8 days. Eighteen (86%) gastric defects closed with EVAC therapy. Mean duration of therapy was 38 days with a mean of 9 endosponge changes every 5.3 days. Three (100%) small bowel defects closed with EVAC therapy. Mean duration of therapy was 13.7 days with a mean of 2.7 endosponge changes every 4.4 days. Six (60%) colorectal defects closed with EVAC therapy. Mean duration of therapy was 23.2 days, consisting of a mean of 6 endosponge changes every 4.0 days. There were two deaths, which were not directly related to EVAC therapy and occurred outside the measured 30-day mortality. Our experience demonstrates that EVAC therapy is feasible and effective for the management of gastrointestinal perforations/leaks throughout the GI tract and can be considered as a safe alternative to surgical intervention in select cases.

Introduction: Boerhaave syndrome is a rare condition associated with high morbidity and mortality. Prompt intervention greatly improves outcomes, with surgery traditionally being the mainstay of management. Recent advances in therapeutic endoscopy have led to increasing interest in endoluminal vacuum therapy (EVT), a minimally invasive technique, allowing wound debridement and drainage, encouraging granulation tissue formation. EVT has been associated with positive clinical outcomes, including lower mortality rates compared to surgery and stenting for the management of anastomotic leaks, and to a lesser extent, oesophageal perforations. EVT has been adopted into practice across Europe; however, only few cases have been reported from the UK. Case Presentations: We report three cases of Boerhaave syndrome, successfully managed with EVT, using the Eso-SPONGE ® (B.Braun Medical Ltd, Sheffield, UK). EVT involves the placement of a polyurethane sponge into the wound cavity. The cavity is initially assessed, then an overtube is introduced through which the sponge is inserted, and then the overtube is removed. Sponge position is confirmed and adjusted if necessary. The sponge is connected via a trans-nasal drain to continuous negative pressure suction and is changed every 3–5 days. Having been deemed surgically unfit, all 3 patients were referred for EVT. All patients made excellent recovery and were discharged home. Conclusion: EVT is an effective management strategy for surgically unfit Boerhaave syndrome patients. Eso-SPONGE use aided drainage of the septic focus and closure of the defect, leading to complete recovery. Our findings support the existing evidence that EVT is a promising solution for Boerhaave syndrome.

Background Perforation of the cervical oesophagus is an extremely rare but recognised complication of thyroidectomy. As with all oesophageal perforations management depends on timing of diagnosis in relation to the timing of injury, the size of the oesophageal wall defect, extent of extraluminal contamination, and how unwell the patient is with respect to sepsis. We report a case of complete transection of the cervical oesophagus during total thyroidectomy and its subsequent management. Methods A previously well 32-year-old female had a complete cervical oesophageal transection during total thyroidectomy and neck dissection for papillary carcinoma of thyroid. This was recognised by her ENT surgeon who repaired the oesophagus primarily. Subsequently, she developed sepsis with cellulitis of her anterior chest wall. Cross-sectional imaging demonstrated a leak at the site of the cervical oesophageal repair. Gastroscopy confirmed a 50% dehiscence of the oesophageal anastomosis. Control and management of her oesophageal leak was achieved with EVT delivered using an ad-hoc endoluminal vacuum device (EVD) constructed from open cell foam sutured around the distal end of a nasogastric tube. Results The patient was managed in the intensive care unit (ICU) with appropriate organ support and antimicrobial cover. A surgical jejunostomy was placed to facilitate enteral feeding. EVT was delivered using the ad-hoc EVD which was placed endoscopically and situated intraluminally across the anastomotic leak site. Continuous negative pressure (125 mmHg) was applied. Six EVD changes were required to heal the leak. Her total length of stay was 41 days, of which 38 days were in ICU. There were no periprocedural complications related to using the EVD or EVT, although the patient subsequently developed an oesophageal stricture which required endoscopic dilatation. Conclusions Accidental complete transection of the cervical oesophagus is extremely rare. This case highlights the importance of a multidisciplinary team approach for managing such cases. EVT is an emerging treatment option for upper gastrointestinal (UGI) leaks and is reported to be safe and effective for leaks from a wide range of causes throughout the UGI tract. Successful resolution of the oesophageal leak in this unusual case demonstrates the utility of EVT in difficult clinical situations which may otherwise pose a formidable management challenge using traditional treatment strategies.

Invited Commentary

Background Endoluminal vacuum therapy (EVT[BA1] ) is a novel, yet relatively well established tool in the management of upper gastrointestinal (UGI) leaks and perforations. Despite a growing body of evidence supporting its use, management strategies and techniques used in the context of EVT are yet to be standardised. Furthermore, the uptake of EVT in the UK is limited to a small number of centres. This project aimed to summarise the key lessons learnt from our initial experience of 450 EVT procedures, to inform others about how this technique can be integrated into regular clinical practice. Methods This study draws on experiential reflections and analysis of a prospective database of 450 EVT procedures in 59 patients in our unit from October 2018 – June 2023. This included patients who had undergone oesophago-gastric (OG) cancer resections, bariatric surgery (index procedures both in the UK and abroad) and those presenting with benign disease (oesophageal perforation and iatrogenic injury). The setting was a regional tertiary OG and bariatric centre in the North West of England serving a cancer and benign population of 3.5 million people and a larger undetermined population for bariatric emergencies. Results 51/59 (86%) patients were successfully managed with 446 EVT procedures. Patient, system and technical factors were identified which when addressed, facilitated expeditious healing of leaks, and enabled active management patients unfit for more invasive interventions. Factors included understanding the indications for using and stopping EVT, control of sepsis, and optimisation of nutrition and glycaemic control. Technical factors included sponge placement, managing foreign material (e.g. redundant sutures and drains) and approaches to managing necrosis. System factors included supporting a training programme, the necessity of a comprehensive team approach and the financial and governance challenges with adopting a novel intervention. Conclusions EVT is as an effective technique in the management of complex UGI leaks and perforations. There are multiple patient, financial, logistical, governance and systems factors that present as challenges to the implementation of this technique into routine practice. An integrated team-based approach is key to adoption of EVT by other centres into their routine practice.

BackgroundMetabolic bariatric surgery (MBS) is standardized and safe. Nevertheless, complications such as anastomotic leakage (AL) or staple-line leakage (SLL) can occur. In upper GI or colorectal surgery, endoluminal vacuum therapy (EVT) offers a therapeutic alternative to revisional surgery. Data on EVT in patients with leakage after MBS remain scarce. The aim of this study is to evaluate the efficacy of EVT and its potential as endoscopic alternative to revisional surgery.Material and MethodsAll patients treated for AL or SLL with EVT after MBS between 01/2016 and 08/2023 at the Department for General Surgery, Medical University Vienna, were included in this retrospective, single-center study. Therapeutic value of EVT as management option for acute postoperative leakage after MBS in daily practice was evaluated. Statistical analyses were performed descriptively.ResultsTwenty-one patients were treated with EVT within the observational period of 7 years. In 11 cases (52.4%), the index surgery was a primary bariatric intervention; in 10 cases (47.6%), a secondary surgery after initial MBS was performed. Favored approach was a combination of revisional surgery and EVT (n = 18; 85.7%), intermediate self-expanding metal stent (SEMS) in 16 (76.2%) cases. EVT was changed six times (0–33) every 3–4 days. Mean EVT time was 25.1 days (3–97). No severe associated complications were detected and EVT showed an efficacy of 95.2%.ConclusionThis small case series supports the trend to establish EVT in daily clinical practice when revisional surgery after MBS is needed, thus preventing further reoperation and reducing associated morbidity and mortality in critically ill patients.Graphical

Upper gastrointestinal tract (UGT) leaks are associated with severe morbidity and mortality. Endoluminal vacuum (EVAC) therapy is a promising approach for repairing effectively these defects. Our study describes the results obtained from a series of cases treated with EVAC for the management of esophageal anastomotic (EA) leak following esophagectomy for cancer, gastroenteric (GE) anastomoses leak after bariatric surgery and esophageal perforation (EP). We retrospectively analyzed ten patients who had an EA and GE anastomoses leaks and EP treated with EVAC. We described the results of the sample in terms of treatment failure, treatment duration, and number of EVAC replacements. Five patients underwent esophagectomy with neoadjuvant radio-chemotherapy, one patient underwent gastrojejunal bypass bariatric surgery and there were four EP. The median size of mucosal defects was 6,9 mm. The median duration of treatment was thirteen days with 3,6 interventions performed, every three to four days. Treatment success rate was 70%. Treatment failure was 30%: two patients required surgery and in one case an endoluminal prosthesis. EVAC therapy is an appropriate treatment for the management of postoperative fistulas in the UGT. Longer treatments are associated with neoadjuvant chemoradiotherapy and larger fistulas.

Management of Upper Gastrointestinal Tract Leaks Using Endoluminal Vacuum Therapy: 10-years’ Experience of a Specialist Esophago-gastric Center

Background Anastomotic leaks following oesophagectomy are associated with significant morbidity and mortality. The management of these leaks also presents significant clinical and nutritional challenges. The role of endoscopic interventions such as endoluminal vacuum therapy and endoscopic stents in management of these leaks has increased over the past decade. We present our experience in the use of endoscopic stents with a stent fixation device over the last 4 years. Method Detailed patient records were retrospectively reviewed to assess the indications, procedural success, complications and overall clinical outcomes for patients with anastomotic leaks following Ivor-Lewis oesophago-gastrectomy (ILO) at our institution from January 2021 to June 2024 treated endoscopically with fully-covered self-expanding metal stents using stent fixation devices. Results 5 patients had post-ILO anastomotic leaks treated with endoscopic stents. The stents were fixed to the proximal oesophagus using a stent fixation device (Stentfix clip). 1of the 5 patients continued to leak despite the stent, leading to prolonged recovery. The remaining 4 achieved leak resolution after stent insertion without needing further intervention. No stent-related procedural complications were noted. The patients progressed on to oral diet/nasogastric feeding within a median of 8 days (Range: 1-18). The median hospital stay following stenting was 29 days (range 7-39). The stents remained in situ for 3 months and were succcesfully removed endoscopically thereafter. Conclusion Endoscopic stenting with a fully covered stent and a stent fixation device (alongside pleural drainage) is a highly effective and safe intervention for managing anastomotic leaks after ILO. It does not entail multiple procedure and oral feeding can be commenced relative quickly. It potentially minimizing the need for more complex procedures and reduces overall hospital stay and costs in the management of anaestomotic leaks.

Background There are around 2,800 oesophageal perforations and leaks in the UK each year, with mortality reaching 50% when diagnosis and subsequent treatment is delayed. Management traditionally involved high-risk invasive surgery with prolonged ITU stays. Over the last 13 years our unit, a tertiary referral centre, has adopted EVT as first-line management for these cases, using an ad-hoc Endoluminal Vacuum Device (EVD). Aims and Methods Our primary aim was to assess the successful perforation/ leak healing rate, overall mortality and complication rate of EVT. Retrospective analysis of a prospectively collated database for all patients who received EVT between May 2011 and October 2024 was performed. Oesophageal, gastric and duodenal perforations were included. Results 108 patients received EVT, median age was 65 years (range 23-92years), median ASA was 3 (range 1-5). M:F=59:49. 87 cases were oesophageal, 17 gastric and 4 duodenal. 45 patients had a post-operative leak, 30 perforations were spontaneous, 27 iatrogenic and 6 traumatic. Leak resolution was achieved in 98 (90.7%) patients. 12 (11.1%) patients died, 7 (6.5%) of which were due to primary treatment failure. 4 (3.7%) significant bleeding events occurred directly related to the leak as a result of undrained sepsis. Conclusion EVT is safe and effective in the management of upper GI leaks irrespective of aetiology. Our unit has achieved a significant reduction in mortality when compared to traditional management. It should be considered for first-line management in patients with a delayed presentation of oesophageal perforation, following anastomotic leaks and select gastric and duodenal perforations.

Anastomotic leakage is a significant complication following colorectal surgery, associated with increased morbidity and mortality. Endoluminal vacuum therapy (EVT) has emerged as a promising treatment option for managing such leaks, although stan-dardized guidelines are still lacking. This study aimed to evaluate the efficacy of EVT in managing anastomotic leakage after colorectal surgery, focusing on outcomes and contributing factors. A retrospective analysis was conducted on 25 patients who underwent EVT for anastomotic leakage between 2018 and 2022 at our institution. Data collected included patient demographics, surgical details, timing of EVT initiation, number of EVT sessions, complications, and outcomes such as leak closure and subsequent surgical interventions. Statistical analyses were performed using Python packages. The study cohort had a mean age of 56.84 years, with 68% being male. All patients received neoadjuvant therapy followed by low anterior resection and diverting ileostomy; 80% underwent open surgery. EVT was initiated for postoperative anastomotic leak-age, with a mean hospital stay of 14.16 days and an average initiation time of 16.16 days post-surgery. Ileostomy closure was performed in 14 patients after endosponge therapy. The overall EVT success rate was 68%, with a mean follow-up period of 30.7 months for those who underwent ileostomy closure. No significant relationship was found between patients' age and the time to first EVT after anastomotic leakage (p=0.52). However, a significant association was observed between the timing of the first EVT and the duration of EVT termination (p=0.0003). EVT is a viable option for managing anastomotic leakage following colorectal surgery, demonstrating high closure rates and low associated morbidity. Early initiation of EVT appears to be crucial for optimizing treatment outcomes. Further pro-spective studies are needed to establish standardized protocols and confirm the long-term benefits of EVT in this challenging clinical context.

INTRODUCTION: Anastomotic leaks can occur in up to 15% of patients undergoing esophagectomy with gastric pull-up. Endoluminal vacuum therapy has become a well-documented technique to treat perforations and anastomotic leaks; however, technical success can vary. We present a case of a lesser curve anastomotic leak after esophagectomy that developed into a large cavity requiring unique techniques for successful endoluminal vacuum therapy. CASE DESCRIPTION/METHODS: A 66-year old male with esophageal adenocarcinoma underwent an Ivor Lewis esophagectomy. On day 20, a CT scan to investigate abdominal pain revealed a lesser curvature staple line leak resulting in an empyema (Figure 1). Chest drainage was performed and a pigtail catheter was maintained to gravity. An EGD was performed given persistent drain output and revealed a 4-cm linear defect into the pleural cavity with substantial debris (Figure 2). Given the size and location, endoluminal vacuum therapy was planned. A 16 Fr nasogastric tube (NGT) was passed nasal to oral and a wound vac sponge was sutured with 3-0 silk to the tip. This was subsequently advanced into the gastric defect and chest cavity and placed to vacuum suction. Given the angulation, a biliary wire was used to maintain visualization. To insert a larger-sized sponge into the cavity, a double-channeled gastroscope was used to simultaneously manipulate two rat tooth forceps. Once a shallow, smaller defect was present, the NGT was transitioned to a 10-mm Jackson-Pratt (JP) silicone flat drain, allowing for easier sponge placement and better approximation. Strict nil per os, antacid therapy, and pigtail chest drainage to bulb suction were key to keep the cavity dry. After 13 exchanges, the defect appeared closed as confirmed with fluoroscopy (Figure 3). DISCUSSION: Endoluminal vacuum therapy is an effective therapy to treat anastomotic leaks after esophagectomy. Several characteristics can alter technical success, and in our case, the angulation at the cavity inlet, linear nature of cavity, and drain management presented challenges. An endoscopically placed wire can be used to maintain visualization of a defect and the use of two rat tooth forceps through a double-channeled gastroscope allows for easier manipulation of the sponge. Bulb suction should be applied to cavity drains for an ideal vacuum effect. The shape and fenestrations of a JP flat drain allow for better positioning into linear defects as they become smaller and apply an evenly distributed gentle vacuum effect.Figure 1.: CT imaging with lesser curvature staple line leak resulting in right posterior pleural space empyema (yellow box).Figure 2.: Initial EGD demonstrating the inlet of the defect (left, black oval) and deep linear cavity (right).Figure 3.: Endoscopic (left, black oval) and fluoroscopy image (right) confirming defect resolution.