Endoluminal vacuum therapy for the treatment of complete dehiscence of low colorectal anastomosis.
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SUBMITTER: Popoutchi P
PROVIDER: S-EPMC8187130 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC6945136 | biostudies-literature
Project description:BackgroundEndoluminal vacuum-assisted therapy (EVT) has been introduced recently to treat colorectal anastomotic leakage. The aim of this study was to evaluate the safety and efficacy of EVT in the treatment of anastomotic leakage and rectal stump insufficiency after Hartmann's procedure.MethodsA systematic search of MEDLINE, Scopus and Cochrane databases was performed using search terms related to EVT and anastomotic leakage or rectal stump insufficiency in line with the PRISMA checklist. Observational studies, RCTs and case series studies published to July 2017 were included. Primary outcomes of the review were the success of EVT, defined as complete or partial healing of the anastomotic defect and associated cavity, and the rate of stoma reversal after EVT. Secondary outcomes included the duration of treatment to complete healing, complications of treatment and the need for further intervention. A meta-analysis was conducted. The potential effect of clinical confounders on the failure of EVT was investigated using the random-effects meta-regression model.ResultsOf 476 articles identified, 17 studies reporting on 276 patients were ultimately included. The weighted mean rate of success was 85·3 (95 per cent c.i. 80·1 to 90·5) per cent, with a median duration from inception of EVT to complete healing of 47 (range 40-105) days. The weighted mean rate of stoma reversal across the studies was 75·9 (64·6 to 87·2) per cent. Twenty-five patients (9·1 per cent) required additional interventions after EVT. Thirty-eight patients (13·8 per cent) developed complications. The weighted mean complication rate across the studies was 11·1 (6·0 to 16·2) per cent. Variables significantly associated with failure included preoperative radiotherapy, absence of diverting stoma, complications and male sex.ConclusionEVT is associated with a high rate of complete healing of anastomotic leakage and stoma reversal. It is an effective option in appropriately selected patients with anastomotic leakage.
| S-EPMC6433422 | biostudies-literature
Project description: Not available
| S-EPMC7650839 | biostudies-literature
Project description:Esophageal anastomotic leak is the most common and serious complication following esophagectomy. However, the standard treatment for anastomotic leaks remains unclear. Recently, endoscopic vacuum therapy has become an important non-surgical alternative treatment method for patients with esophageal anastomotic leak. This treatment involves the endoscopic placement of a sponge connected to a nasogastric tube into the defect cavity or lumen. Subsequently, continuous negative pressure is delivered to the cavity through the tube. Several studies have reported a treatment success rate of 80% to 100%. In this study, we review the mechanism of action, the method of performing the procedure, its safety and efficacy, and prognostic factors for failure of endoscopic vacuum therapy in the management of patients with anastomotic leak, and on this basis attempted to confirm the possibility of establishing a standardized treatment protocol using endoscopic vacuum therapy.
| S-EPMC7409879 | biostudies-literature
Project description:Dehiscence of colorectal anastomosis is a serious complication that is associated with increased mortality, impaired functional and oncological outcomes. The hypothesis was that anastomosis reinforcement and vacuum trans-anal drainage could eliminate some risk factors, such as mechanically stapled anastomosis instability and local infection. Patients with rectal cancer within 10 cm of the anal verge and low anterior resection with double-stapled technique were included consecutively. A stapler anastomosis was supplemented by trans-anal reinforcement and vacuum drainage using a povidone-iodine-soaked sponge. Modified reinforcement using a circular mucosa plication was developed and used. Patients were followed up by postoperative endoscopy and outcomes were acute leak rate, morbidity, and diversion rate. The procedure was successfully completed in 52 from 54 patients during time period January 2019-October 2020. The mean age of patients was 61 years (lower-upper quartiles 54-69 years). There were 38/52 (73%) males and 14/52 (27%) females; the neoadjuvant radiotherapy was indicated in a group of patients in 24/52 (46%). The mean level of anastomosis was 3.8 cm (lower-upper quartiles 3.00-4.88 cm). The overall morbidity was 32.6% (17/52) and Clavien-Dindo complications ≥ 3 grade appeared in 3/52 (5.7%) patients. No loss of anastomosis was recorded and no patient died postoperatively. The symptomatic anastomotic leak was recorded in 2 (3.8%) patients and asymptomatic blind fistula was recorded in one patient 1/52 (1.9%). Diversion ileostomy was created in 1/52 patient (1.9%). Reinforcement of double-stapled anastomosis using a circular mucosa plication with combination of vacuum povidone-iodine-soaked sponge drainage led to a low acute leak and diversion rate. This pilot study requires further investigation.Registered at ClinicalTrials.gov.: Trial registration number is NCT04735107, date of registration February 2, 2021, registered retrospectively.
| S-EPMC8606370 | biostudies-literature
Project description:IntroductionEndoscopic treatment by vacuum therapy (EVT) or covered stents has emerged as an improved treatment option for upper gastrointestinal wall defects and is regarded as an improved treatment option for anastomotic leakage (AL) after esophagectomy. However, endoluminal EVT devices may lead to obstruction of the GI tract; and a high rate of migration and missing functional drainage has been shown for covered stents. The recently developed VACStent, a combination of a fully covered stent within a polyurethane sponge cylinder may overcome these issues allowing EVT while stent passage is still open. Initial clinical applications have demonstrated efficacy, practicability and safety in the treatment of esophageal leaks (AL).MethodsIn this pilot study, 9 patients with high-risk anastomosis after neoadjuvant therapy undergoing hybrid esophagectomy received the VACStent in a preemptive setting for the assessment of the reduction of the AL rate, postoperative morbidity and mortality.ResultsTechnical success of the application of the VACStent® was achieved in all interventions. One patient experienced anastomotic leakage 10 days after esophagectomy and was successfully treated with two consecutive VACStents and a VAC Sponge. In summary, mortality in-hospital was 0% and anastomotic healing was uneventful without septic episodes. No severe device-related adverse events (SADE) nor significant local bleeding or erosion could be observed. Oral intake of liquids or food was documented in all patients. The device handling was regarded uncomplicated.DiscussionThe preemptive application of the VACStent offers a promising new option for improved clinical treatment avoiding of critical situations in hybrid esophagectomy, which should be validated in a large clinical study.
| S-EPMC10097441 | biostudies-literature
Project description:Background and study aims Esophageal defects (leaks, fistulas, and perforations) are associated with significant morbidity and mortality. Endoluminal vacuum-assisted closure (EVAC) is a novel intervention that entails the use of sponges in the defect along with negative pressure to achieve granulation tissue formation and healing and has been gaining popularity. We performed a systematic review and pooled analysis of available literature to assess the safety and effectiveness of EVAC for esophageal defects. Patients and methods We queried PubMed/Medline, Embase, Cochrane, and Web of Science through September 25, 2020 to include all pertinent articles highlighting the safety and effectiveness profile of EVAC for esophageal defects. Pooled rates, 95 % confidence intervals (CIs), and heterogeneity ( I 2 ) were assessed for each outcome. Results A total of 18 studies with 423 patients were included (mean age 64.3 years and males 74.4 %). The technical success for EVAC was 97.1 % (CI: 95.4 %-98.7 %, I 2 = 0 %). The clinical success was 89.4 % (CI: 85.6 %-93.1 %, I 2 = 36.8 %). The overall all-cause mortality and adverse events (AEs) noted were 7.1 % (CI: 4.7 %-9.5 %, I 2 = 0 %) and 13.6 % (CI: 8.0 %-19.1 %, I 2 = 68.9 %), respectively. The pooled need for adjuvant therapy was 15.7 % (CI: 9.8 %-21.6 %, I 2 = 71.1 %). Conclusions This systematic review and meta-analysis showed high rates of technical success, clinical success, and low all-cause mortality and AEs using EVAC. Although the technique is a promising alternative, the lack of comparative studies poses a challenge in making definite conclusions regarding use of EVAC compared to other endoscopic modalities, such as clips and stents.
| S-EPMC8367451 | biostudies-literature
Project description:Background and aimsGI perforations, leaks, and fistulas are types of full-thickness mural defects that frequently occur as adverse events from GI surgeries such as esophagectomy for malignancy and bariatric surgery. Historically, treatment has entailed a combination of reoperation, percutaneous drainage, and bowel rest. Recently, there has been a changing paradigm in the management of these defects. Endoscopic interventions, including endoclipping and placement of self-expanding metal stents (SEMSs), have been increasingly used with good success. Despite this, some defects remain refractory to these techniques. Endoscopic vacuum-assisted closure (EVAC) is a new, promising endoscopic approach to repairing these defects. EVAC works through applying continuous, controlled negative pressure at the defect with the use of an endoscopically placed polyurethane sponge connected to an electronic vacuum device. EVAC has been shown to be feasible, safe, and effective.MethodsWe present a video series of 3 cases demonstrating the successful application of EVAC for the treatment of anastomotic leakage after esophagectomy and of fistula formation after bariatric surgery.ResultsTwo patients experienced anastomotic leakage after esophagectomy for esophageal adenocarcinoma, and 1 patient experienced a chronic gastric fistula after Roux-en-Y gastric bypass. The gastric bypass patient's fistula failed to resolve with over-the-scope-clip placement, and all 3 patients' defects did not heal despite SEMS placement; therefore, EVAC was performed. The bariatric surgery patient required 9 sponge exchanges over 35 days, and the 2 esophagectomy patients each required 3 sponge exchanges over 13 days. All 3 patients had resolution of their defects with EVAC. No adverse events occurred, and all patients have had no recurrence for several months.ConclusionsThese cases help to highlight the feasibility, safety, and efficacy of EVAC for the closure of full-thickness GI defects. On the basis of our experience, the use of EVAC should be considered for these complex and refractory cases.
| S-EPMC6318080 | biostudies-literature
Project description:IntroductionEndoscopic vacuum therapy (EVT) has gained a greater role in management of transmural defects in the upper gastrointestinal (GI) tract, including anastomotic leakage and esophageal perforation (e.g. Boerhaave syndrome and iatrogenic causes). The vacuum-stent is a new treatment modality, combining the benefits of EVT and an intraluminal stent.Patients and methodsThis prospective case series describes the first ten cases of a transmural defect in the upper GI tract treated with a vacuum-stent in a tertiary referral center. All patients signed informed consent for prospective registration of relevant data on treatment and outcomes in a specially designed database. Outcome parameters were successful closure of the defect, number of endoscopies, duration of treatment and adverse events.ResultsIn total, ten patients treated with a vacuum-stent were included. Eight patients had anastomotic leakage after esophageal resection, of whom six were treated with vacuum-sponge and vacuum-stent, and two with vacuum-stent only. One patient had Boerhaave syndrome, treated with vacuum-sponge and vacuum-stent, and one had an iatrogenic perforation during pneumodilation for achalasia, treated with vacuum-stent only. Success rate was 100%, requiring a median of 5 (IQR 3-12) EVT-related endoscopies with a treatment course of median 18 (IQR 12-59) days. One patient developed an esophageal stricture, but no other vacuum-stent related adverse events were observed.ConclusionThe vacuum-stent, which combines benefits of EVT and an intraluminal stent, shows great feasibility and efficacy in treatment of transmural defects in the upper GI tract. Future studies should point out whether this device can prevent major (re-)surgery in these patients.
| S-EPMC10010284 | biostudies-literature
Project description:INTRODUCTION:Anastomotic leakage (AL) remains one of the most threatening complications in colorectal surgery with the incidence of up to 20%. The aim of the study is to evaluate the safety and feasibility of novel - trimodal intraoperative colorectal anastomosis testing technique. METHODS AND ANALYSIS:This multi-center prospective cohort pilot study will include patients undergoing colorectal anastomosis formation below 15?cm from the anal verge. Trimodal anastomosis testing will include testing for blood supply by ICG fluorescence trans-abdominally and trans-anally, testing of mechanical integrity of anastomosis by air-leak and methylene blue leak tests and testing for tension. The primary outcome of the study will be AL rate at day 60. The secondary outcomes will include: the frequency of changed location of bowel resection; ileostomy rate; the rate of intraoperative AL; time, taken to perform trimodal anastomosis testing; postoperative morbidity and mortality; quality of life. DISCUSSION:Trimodal testing of colorectal anastomosis may be a novel and comprehensive way to investigate colorectal anastomosis and to reveal insufficient blood supply and integrity defects intraoperatively. Thus, prevention of these two most common causes of AL may lead to decreased rate of leakage. STUDY REGISTRATION:Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03958500, May, 2019.
| S-EPMC6959889 | biostudies-literature