OTSC® clinical success of 74.3% in treatment of colorectal anastomotic leaks and fistulae
A systematic review evaluating 9 studies with overall 107 patients who underwent closure of anastomotic leak or fistula with the OTSC® after colorectal surgery showed a technical success rate of 84 % and a clinical success rate of 74.3 %. Complications were reported in two patients.
Q. Wang et al., Shanxi Medical University, Taiyuan, China, performed a systematic review of studies evaluating OTSC-mediated closure of anastomotic leaks and fistulas published between 01/2010 and 01/2021.
Anastomotic leak is among the most serious complications that can develop following colorectal surgery, causing significant morbidity and mortality in affected patients. Surgical revision can induce significant trauma and treatment-related complications. Conventional endoscopic approaches such as ENDOVAC, SEMS and standard clips can be associated with adverse events such as stent migration and/or have limitations regarding defect size. The OTSC is capable of bridging the gap between conventional endoscopic and surgical procedures.
For the review, the PubMed/Medline, EMBASE, and Cochrane PubMed Library were systematically searched for all relevant studies examining application of the OTSC for therapy of a post-surgical colorectal anastomotic leak or fistula. Review articles, case reports, abstracts, case report commentaries, and studies of other surgical or treatment procedures were excluded from the analysis. Technical success was defined as the rate of successful deployment of the OTSC over the defect. Clinical success was defined as complete durable closure of the leak without any evidence of additional leakage during follow-up.
A total of nine studies met the inclusion criteria, incorporating 114 patients of whom 107 were treated with an OTSC. The age range of patients in these nine studies was 20-88 years. The male-to-female ratio (reported in 7 studies) was 32:20. Seven studies reported leak sizes, which included ≤ 15 mm (n=45) and > 15 mm (n=10). Follow-up times were reported in six studies and ranged from 1 to 1070 days. Technical success rate and clinical success rate were calculated using a pooled proportion analysis and amounted to 84% (95%CI, 73.5–94.5%; I2 53%), and 74.3% (95%CI, 64.4–84.1%; I2 28%), respectively. OTSC-related complications were reported in two patients: one case of deformation of the lumen by retraction and one case of impossible OTSC deployment owing to extensive tissue fibrosis.
The authors concluded that the OTSC System is a safe and highly effective tool for management of anastomotic leaks and fistulas after colorectal surgery, associated with a low complication rate. As such, the OTSC should be widely used in clinical practice.
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