Transrectal Drainage Tube Use for Preventing Post-endoscopic Submucosal Dissection Coagulation Syndrome in Patients with Colorectal Lesions: A Multicenter Randomized Controlled Clinical Trial.

ABSTRACT

INTRODUCTION: Post-endoscopic submucosal dissection (ESD) coagulation syndrome (PECS) prevention is one of the common postoperative complications of colorectal ESD. Considering the increasing incidence of PECS, it is critical to investigate various prevention To evaluate the efficacy of transrectal drainage tubes (TDTs) in PECS prevention in patients following colorectal ESD. METHODS: From July 2022 to July 2023, a multicenter, randomized controlled clinical trial was conducted in 3 hospitals in China. Patients with superficial colorectal lesions ≥20 mm who had undergone ESD for a single lesion were enrolled. Initially, 229 patients were included in the study and 5 were excluded. 224 were randomly assigned to the TDT and non-TDT group in the end. This open-label study utilized a parallel design with a 11 allocation ratio, and endoscopists and patients were not blind to the randomization. And a 24Fr drainage tube was inserted approximately 10-15 cm above the anus after the ESD under the endoscopy and tightly attached to a drainage bag. The TDTs were removed in 1 to 3 days following the ESD. RESULTS: A total of 229 eligible patients were enrolled in this study and 5 patients were excluded. Ultimately, 224 patients were assigned to the TDT group(n=112) and non-TDT group(n=112). The median age for the patients was 63.45(IQR 57-71; 59 men [52.68%]) in the TDT group and 60.95(IQR 54-68; 60 men [53.57%]) in the non-TDT group. Intention-to-treat analysis showed patients in the TDT group had a lower incidence of PECS than patients in the non-TDT group (7 [6.25%] vs 20 [17.86%]; relative risk, 0.350; 95% CI,0.154-0.795; P =0.008). In the subgroup analysis, TDTs were found to prevent PECS in patients of the female gender(odd ratio, 0.097; 95% CI, 0.021-0.449; P =0.001), tumor size ＜4cm(odd ratio, 0.203; 95% CI, 0.056-0.728; P = 0.011), tumor located in the left-sided colorectum (odd ratio, 0. 339 95% CI, 0.120-0.957; P = 0.035) and shorter procedure time(＜45 mins) (odd ratio, 0.316; 95% CI, 0.113-0.879; P =0.023). The tube fell off in 1 case (0.89%) accidentally ahead of time. No TDT-related complication was observed. DISCUSSION: The results from this randomized clinical study indicate that the application of TDTs effectively reduced the incidence of PECS in patients after colorectal ESD (chictr.org.cn Identifier ChiCTR2200062164).