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Randomized Controlled Trial
. 2021 Dec 1;156(12):1151-1158.
doi: 10.1001/jamasurg.2021.4568.

Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial

Song Zhao  1 , Luyang Zhang  2 , Feng Gao  3 , Miao Wu  4 , Jianyong Zheng  5 , Lian Bai  6 , Fan Li  1 , Baohua Liu  1 , Zehui Pan  3 , Jian Liu  4 , Kunli Du  5 , Xiong Zhou  6 , Chunxue Li  1 , Anping Zhang  1 , Zhizhong Pu  7 , Yafei Li  8 , Bo Feng  2 , Weidong Tong  1
Affiliations
Randomized Controlled Trial

Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial

Song Zhao et al. JAMA Surg. .

Abstract

Importance: Preventing anastomotic leakage (AL) is crucial for colorectal surgery. Some studies have suggested a positive role of transanal drainage tubes (TDTs) in AL prevention after low anterior resection, but this finding is controversial.

Objective: To assess the effect of TDTs in AL prevention after laparoscopic low anterior resection for rectal cancer.

Design, setting, and participants: This multicenter randomized clinical trial with parallel groups (TDT vs non-TDT) was performed from February 26, 2016, to September 30, 2020. Participants included patients from 7 different hospitals in China who were undergoing laparoscopic low anterior resection with the double-stapling technique for mid-low rectal cancer; 576 patients were initially enrolled in this study, and 16 were later excluded. Ultimately, 560 patients were randomly divided between the TDT and non-TDT groups.

Interventions: A silicone tube was inserted through the anus, and the tip of the tube was placed approximately 5 cm above the anastomosis under laparoscopy at the conclusion of surgery. The tube was fixed with a skin suture and connected to a drainage bag. The TDT was scheduled for removal 3 to 7 days after surgery.

Main outcomes and measures: The primary end point was the postoperative AL rate within 30 days.

Results: In total, 576 patients were initially enrolled in this study; 16 of these patients were excluded. Ultimately, 560 patients were randomly divided between the TDT group (n = 280; median age, 61.5 years [IQR, 54.0-68.8 years]; 177 men [63.2%]) and the non-TDT group (n = 280; median age, 62.0 years [IQR, 52.0-69.0 years]; 169 men [60.4%]). Intention-to-treat analysis showed no significant difference between the TDT and non-TDT groups in AL rates (18 [6.4%] vs 19 [6.8%]; relative risk, 0.947; 95% CI, 0.508-1.766; P = .87) or AL grades (grade B, 14 [5.0%] and grade C, 4 [1.4%] vs grade B, 11 [3.9%] and grade C, 8 [2.9%]; P = .43). In the stratified analysis based on diverting stomas, there was no significant difference in the AL rate between the groups, regardless of whether a diverting stoma was present (without stoma, 12 [5.8%] vs 15 [7.9%], P = .41; and with stoma, 6 [8.3%] vs 4 [4.5%], P = .50). Anal pain was the most common complaint from patients in the TDT group (130 of 280, 46.4%). Accidental early TDT removal occurred in 20 patients (7.1%), and no bleeding or iatrogenic colonic perforations were detected.

Conclusions and relevance: The results from this randomized clinical trial indicated that TDTs may not confer any benefit for AL prevention in patients who undergo laparoscopic low anterior resection for mid-low rectal cancer without preoperative radiotherapy.

Trial registration: ClinicalTrials.gov Identifier: NCT02686567.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure.
Figure.. Study Flow Diagram
TDT indicates transanal drainage tube.
See this image and copyright information in PMC

Comment in

References

    1. Spinelli A, Anania G, Arezzo A, et al. . Italian multi-society modified Delphi consensus on the definition and management of anastomotic leakage in colorectal surgery. Updates Surg. 2020;72(3):781-792. doi:10.1007/s13304-020-00837-z - DOI - PubMed
    1. Caulfield H, Hyman NH. Anastomotic leak after low anterior resection: a spectrum of clinical entities. JAMA Surg. 2013;148(2):177-182. doi:10.1001/jamasurgery.2013.413 - DOI - PubMed
    1. Salvans S, Mayol X, Alonso S, et al. . Postoperative peritoneal infection enhances migration and invasion capacities of tumor cells in vitro: an insight into the association between anastomotic leak and recurrence after surgery for colorectal cancer. Ann Surg. 2014;260(5):939-943. doi:10.1097/SLA.0000000000000958 - DOI - PubMed
    1. Wu Y, Zheng H, Guo T, Keranmu A, Liu F, Xu Y. Temporary diverting stoma improves recovery of anastomotic leakage after anterior resection for rectal cancer. Sci Rep. 2017;7(1):15930. doi:10.1038/s41598-017-16311-7 - DOI - PMC - PubMed
    1. Chapman WC Jr., Subramanian M, Jayarajan S, et al. . First, do no harm: rethinking routine diversion in sphincter-preserving rectal cancer resection. J Am Coll Surg. 2019;228(4):547-556.e8. doi:10.1016/j.jamcollsurg.2018.12.012 - DOI - PMC - PubMed

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