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Evidence - Endoluminal Vacuum Therapy with the Endo-SPONGE® for the Treatment of Anastomotic Insufficiency of the Lower GI Tract

  1. Summary of the Literature

    Endoscopic Vacuum Therapy for the Treatment of Colorectal Leaks

    Since the first reports in the late 1990s, vacuum-assisted wound therapy has conquered almost all areas of surgery, as it is a versatile and easy-to-use method for treating complicated wounds [1]. In 2001, Weidenhagen et al. began using endoscopic vacuum therapy for the management of complications from colorectal anastomotic insufficiencies as a "minimally invasive method for continuous and effective drainage of perianastomotic abscesses and fistulas in the pelvic region in combination with debridement and consecutive mechanical closure of the leak" [2]. In 28 out of 29 cases of colorectal anastomotic insufficiency, these healed after endoluminal vacuum therapy (EVT) without renewed surgical intervention [2]. Subsequently, EVT was successfully used for the interventional treatment of various defects in the upper and lower gastrointestinal tract [3] and has been available as a certified medical product since 2007 (Eso-, Endo-SPONGE®).

    Anastomotic leaks (AL) and other colorectal defects such as Hartmann's stump leaks are associated with high morbidity and mortality [4]. The incidence of AL in rectal cancer surgeries ranges from 6 to 30% with an average of 11%, depending on the height of the anastomosis [4]. Therefore, a significant number of patients are affected by this serious complication.

    The EVT of colorectal leaks is based on the transanal placement of an open-cell microporous sponge intraluminally at the level of the AL (or other colorectal defects) or through the leak into an extraluminal perianastomotic abscess cavity using flexible endoscopes [2]. The negative pressure ("vacuum") is applied via an evacuation tube attached to the sponge [5]. The sponge is usually changed every 2-4 days until the infection has subsided and the defect is closed with granulation tissue, which can be demonstrated endoscopically [5]. This active drainage of the infection site leads to a reduction in bacterial contamination, local edema, and secretion, demonstrably improves blood circulation, and induces granulation tissue [7].

    EVT has become a standard treatment for surgical leaks in many - predominantly European countries - [5-26]. A wealth of smaller observational studies and case series have been published on this topic, but no data from randomized controlled trials. A systematic review and meta-analysis on the efficacy and safety of the treatment of colorectal leaks from 2022 has filled this gap [27]. Following an appropriate database search, 24 studies with a total of 690 patients with colorectal defects (after colorectal procedures including Hartmann, diverticular perforations, trauma) who underwent EVT were included. The study concluded that EVT is a feasible treatment option with manageable risks for selected patients with colorectal leaks:

    1. Duration of EVT treatment and number of sponge changes: 23.4 days and 6.8 sponge changes.

    2. Success rate of EVT: 81.5%

    3. Frequency of stoma creation: 76.4%

    4. Mean stoma reversal rate after EVT: 66.7% (415 patients required only a temporary stoma, 139 patients did not require stoma creation)

    5. EVT complications (fistulas, stenoses, presacral abscesses, bleeding): 12.1%

    6. EVT-associated mortality: 0%

Currently ongoing studies on this topic

Prospective Observational Multicenter Study of Anastomotic Leakage After Colon Cancer Surgery (ANAC

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