Song Zhao1, Luyang Zhang2, Feng Gao3, Miao Wu4, Jianyong Zheng5, Lian Bai6, Fan Li1, Baohua Liu1, Zehui Pan3, Jian Liu4, Kunli Du5, Xiong Zhou6, Chunxue Li1, Anping Zhang1, Zhizhong Pu7, Yafei Li8, Bo Feng2, Weidong Tong1. 1. Gastric and Colorectal Surgery Division, Department of General Surgery, Army Medical Center (Daping Hospital), Army Medical University, Chongqing, China. 2. Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 3. Department of Colorectal and Anal Surgery, The 940th Hospital of Joint Logistics Support Force of The Chinese People's Liberation Army, Gansu, China. 4. Department of Gastrointestinal and Hernia Surgery, Second People's Hospital of Yibin, Yibin, China. 5. Department of Gastrointestinal Surgery, The First Affiliated Hospital of Air Force Medical University, Xi'an, China. 6. Department of Gastrointestinal Surgery, Yongchuan Hospital of Chongqing Medical University, Chongqing, China. 7. Department of Gastrointestinal and Breast Surgery, The People's Hospital of Kaizhou District, Chongqing, China. 8. Department of Epidemiology, College of Preventive Medicine, Army Medical University, Chongqing, China.
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.
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.
Authors: Peter Tschann; Markus P Weigl; Philipp Szeverinski; Daniel Lechner; Thomas Brock; Stephanie Rauch; Jana Rossner; Helmut Eiter; Paolo N C Girotti; Tarkan Jäger; Jaroslav Presl; Klaus Emmanuel; Alexander De Vries; Ingmar Königsrainer; Patrick Clemens Journal: Langenbecks Arch Surg Date: 2022-07-18 Impact factor: 2.895
Authors: Antonio Sciuto; Roberto Peltrini; Federica Andreoli; Andrea Gianmario Di Santo Albini; Maria Michela Di Nuzzo; Nello Pirozzi; Marcello Filotico; Federica Lauria; Giuseppe Boccia; Michele D'Ambra; Ruggero Lionetti; Carlo De Werra; Felice Pirozzi; Francesco Corcione Journal: J Clin Med Date: 2022-05-07 Impact factor: 4.964
Authors: Maria Michela Chiarello; Valentina Bianchi; Pietro Fransvea; Giuseppe Brisinda Journal: World J Gastroenterol Date: 2022-07-28 Impact factor: 5.374