Endoscopic vacuum therapy for the treatment of colorectal leaks — a systematic review and meta-analysis

Since the first reported data in the late 1990s, vacuum-assisted wound therapy has captured nearly every field of surgery by providing a versatile and easy-to-handle method for complicated wounds [1]. In 2001, Weidenhagen et al. started to implement endoscopic vacuum therapy (EVT) at our institution for complication management of anastomotic leakage (AL) after rectal cancer surgery, as a “minimally invasive method for continuous and effective drainage of perianastomotic abscesses and fistula in the pelvic region in combination with debridement and consecutive mechanical closure of the leakage” [2]. Successful definite treatment in 28 of 29 cases of AL without surgical reintervention had been achieved [2].

In the further course, EVT has been successfully applied for interventional treatment of different defects in the upper and lower gastrointestinal tract [3]. AL and other colorectal defects such as Hartmann stump leaks are associated with serious morbidity and mortality [4]. The incidence of AL in rectal cancer surgery ranges between 6 and 30% with an average of 11%, depending on the height of the anastomosis [4]. Therefore, a relevant number of patients are affected by this serious complication and require the best available treatment option. Although preliminary reports showed promising results for EVT in the treatment of colorectal leaks with high success rates and anastomotic salvage, data determining the superiority of EVT over other forms of conservative treatment in diverted anastomoses is lacking [5, 6].

EVT of colorectal leaks is based on the transanal placement of an open-cell microporous sponge intra luminally at the site of-the AL (or other colorectal defects) or through the leak into a extraluminal perianastomotic abscess cavity using a flexible endoscopy [2]. A negative pressure (“vacuum”) is applied via an evacuation tube fixed to the sponge [7]. The sponge is usually changed every 2–4 days until the infection is cleared, and the defect is closed with granulation tissue as proven by endoscopy [7]. This active drainage of the infectious focus results in a decrease of bacterial contamination, local edema, and secretion and is proven to increase perfusion and induce granulation tissue [7].

The conventional treatment of gastrointestinal defects with surgical reinterventions often results in gastrointestinal discontinuity. Additionally, there are other endoscopic therapeutic options like application of stents or attempts for clip closure with uncertain success rates [3]. Today, EVT has evolved to a standard treatment of postoperative surgical leaks in many—mostly European—countries and surgical departments [7‐28]. Yet, evidence on efficacy of EVT in the treatment of colorectal leaks lacks high-quality data from randomized controlled trials (RCT), and only few large observation studies are available [26, 27]. In fact, most data on EVT are based on small case series [8, 17, 21, 28‐30]. Previously published systematic reviews analyzed the available data on EVT in colorectal defects with small sample sizes within included studies resulting in analysis of up to n = 334 patients in total [5, 31, 32]. Nevertheless, in the past few years, the number of studies has increased, reporting high success and low complication rates [5, 6, 27, 33] including a large retrospective series of n = 281 cases with the use of EVT treatment on colorectal defects from our institution including the previously published cases of Weidenhagen et al. [2, 27]. To obtain the best available evidence for EVT in the treatment of colorectal leaks, we performed a systematic review and meta-analysis.

EVT was invented and introduced into clinical practice approximately 20 years ago and is currently applied for upper and lower gastrointestinal defects in over 40 countries [2]. However, still no data from RCTs comparing its outcome to any other endoscopic or surgical approach is available. The current systematic review offers the best available evidence for its use in the management of colorectal defects.

Colorectal defects in rectal cancer surgery, surgery for diverticular disease, or traumatic rectal injury are severe medical conditions and mostly difficult to treat with relevant risk for further morbidity and even mortality [4, 38]. With a weighted mean success rate of 81% in this meta-analysis, EVT is a promising, interventional treatment option which is thought to prevent redo-surgery including emergency discontinuity resection in the majority of patients. Although the cumulative experience is still limited and our analysis lacks a control cohort, EVT can be considered one treatment option of the abovementioned conditions.

A systematic review of the risk factors for EVT was performed. Only a very few studies reported on predictors for success or failure for EVT: Von Bernstoff et al. reported that healing took significantly longer when patients received neoadjuvant pretreatment with 31.6 days versus 12.3 days (p < 0.001) [10]. Abdalla et al. found female sex (p = 0.033) to be associated with EVT success. Furthermore, EVT duration of 21 days or less was associated with a higher rate of success (p = 0.017) undergoing primary EVT with 73% compared to salvage with 33% (p = 0.006) and when EVT was initiated within 15 days with 72.4% compared to more than 15 days with 27.8% after the diagnosis of AL (p = 0.003) [26]. This was supported by the study of Kühn et al. where the risk factors for EVT failure were multi-visceral resection (p = 0.037) and surgical revision after primary surgery (p = 0.009) [27]. Furthermore, Jimenez-Rodriguez et al. found better results in patients who underwent earlier EVT < 6 weeks after primary surgery compared to a later start (p = 0.041) [22].

Because in previous reports it was concluded that bowel diversion is necessary for the effectiveness of EVT in case of AL [6], we examined the number of any kind of diverting ostomies during EVT in the included studies. Surprisingly, we found a weighted mean fecal diversion rate of only 76%. The exact reasons are not described in the underlying data, but most likely in some cases with extraluminal defects or perianastomtic cavities EVT treatment can be successfully performed without diverting ostomy. If the sponge can mainly be placed in the extraluminal defect being accessed transanally through the anastomatic leak, this ensures free luminal passage for the bowel content, whereas in cases the sponge completely obstructs the rectal lumen, EVT is unlikely to be successful [39].

Ostomy reversal was finally possible in only 63% of cases, which is in accordance with the other available data reporting of ostomy reversal rates of 30–40% following AL [40]. Of note, in this series, also rectal stump insufficiency following Hartmann’s procedure was included. Therefore, the ostomy reversal rate should not be considered as a main indicator for the effectiveness of EVT, since restoration of bowel continuity (Hartmann reversal) is usually performed in only about 25–47% of cases even without Hartmann stump insufficiency [41, 42]. On the other hand, as another 139 patients did not need an ostomy at all, 76.1% of patients were ostomy free in further clinical course (415/568). A recently published meta-analysis only including EVT in cases of AL and excluding discontinuity resections reported an ostomy reversal rate of 73% (95% CI: 62–84%) [31]—-although this might represent the subgroup with a less severe clinical problem.

Despite the promising results, the possible complications of EVT should be kept in mind. Considering that these mostly seriously ill patients have a median weighted complication rate of only 12%, EVT has an acceptable safety profile. In this meta-analysis, anastomotic stenosis represented the majority of EVT-associated complications, occurring in a total of 24 patients [7, 11, 12, 18, 22, 27]. As even the rate of anastomotic stenosis following rectal resection was reported to be 22% [43]. As shown in the study by Weidenhagen et al. all stenoses could be successfully treated with an average of six balloon dilations, and an overall ostomy closure rate of 88% was achieved [2]. Other reported complications are fistulas in n = 17 [13, 16, 24, 25, 27], abscesses in n = 15 [9, 11, 16, 22, 23] and bleeding in n = 9 cases [7, 9, 25, 27] in total.

The duration of therapy is one of the major concerns regarding EVT with a weighted treatment duration of 23.4 days (with a range of up to 258 days). Such a long treatment duration, however, may be limited to single cases. One advantage of EVT treatment compared to surgical alternatives is the possibility to transfer a patient into an outpatient setting during treatment [27].

This systematic review is limited by the sparse—and overall quality of available data on EVT. Only data from few prospective studies and no RCT have yet been reported. Most of the included manuscripts are based on a small number of patients. It should also be emphasized that the largest cohort included in this study was published from our institution, which could possibly lead to confirmation bias. The use of EVT in this analysis was not standardized as it was applied to a variety of indications using different techniques. Due to this clinical heterogeneity and the quality of available data, there is a significant heterogeneity among the studies and their background. A relevant selection bias regarding the primary outcome parameter of EVT treatment success needs to be addressed since a complete anastomotic dehiscence with generalized peritonitis will not be treated by EVT, but surgically, and, therefore, is not reported in the included data. The high success rate of about 80% can only be applied to the cases with an extraperitoneal defect without a complete circular necrosis. Therefore, in the treatment of colorectal defects, patients must be selected for the appropriate treatment concept. EVT appears to function well in patients with extraperitoneal colorectal defects in combination with a diverting stoma and without signs of a generalized peritonitis. In these selected cases, EVT is characterized by a good treatment success and moderate complication rates.

Regarding long-term incidence of complications, but also oncological outcome, future prospective, comparative studies with large sample sizes are urgently needed.

This systematic review and meta-analysis is the largest body of evidence currently collected on EVT. Based on the sparse data, it shows that EVT is a feasible treatment option with manageable risk for selected patients with colorectal leaks.