Shoichi Fujii, MD, PhD1, Atsushi Ishibe, MD, PhD2, Mitsuyoshi Ota, MD, PhD2, Kazuteru Watanabe, MD, PhD2, Jun Watanabe3, Chikara Kunisaki, MD, PhD3, Itaru Endo2. 1Department of Gastroenterological Surgery, International University Health and Welfare, Ichikawa hospital, 2Department of Gastroenterological Surgery, Yokohama City University, Graduate School of Medicine, 3Department of Surgery, Gastroenterological Center, Yokohama City University
Background: In rectal anterior resection, the optimal level for inferior mesenteric artery (IMA) ligation has been controverted for many years because of a lack of randomized trial. A clinical question is whether preservation of blood supply by the left colic artery (LCA) improve anastomotic outcome. We conducted the randomized trial (HTLT study) that the IMA should be tied at the origin (high tie, HT) or distal to the left colic artery (low tie, LT). This study is the sub analysis of HTLT study in laparoscopic rectal anterior resection.
Methods: Patients were randomly allocated to undergo HT or LT. In LT, the lymph nodes around the origin of IMA were dissected. The stratified factor was the approach (open or laparoscopy). Evaluation parameters were operative factors, and postoperative short- and long-term results. A sample size of 400 was planned and only short-term results were analyzed. An abdominoperineal resection, Hartmann’s operation and intersphicteric resection were excluded. The primary endpoint was the incidence of anastomotic leakage. A sample size of 362 patients was used to achieve a power of more than 80% in order to detect a difference between the groups using a two-sided chi-square test with a type I error rate equal to 0.05, when true complication rates were 6% and 15% for LT and HT groups, respectively. Dropouts were considered, and the number of accumulation targets was assumed to be 400 patients. In this study, laparoscopic surgeries were analyzed.
Results: From June 2006 to September 2012, 331 patients were registered, with 7 patients excluded because of procedural changes. Two hundred and fifteen patients (107 for HT: 108 for LT) were laparoscopic anterior resection in 324 patients. There was no difference between HT and LT in backgrounds. The incidence of anastomotic leakage (HT: LT %) showed no significant differences for all grades (21.5:14.8), grade 2 or higher (11.2:9.3), and grade 3 or higher (2.8:4.6). There were no differences in operative time (200:205 min), blood loss (15:15 ml), number of dissected lymph node (22:20) and postoperative hospital stay (10:10 days). The time between the start of surgery and IMA ligation was longer in LT (38:54 min). The identified risk factors for leakage were being male and tumor distance from the anal verge, in multivariate analysis by logistic regression.
Conclusion: LT was not an effective procedure for the prevention of anastomotic leakage in a laparoscopic rectal anterior resection. (ClinicalTrials.gov.: NCT01861678)
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 86920
Program Number: S121
Presentation Session: Colorectal 2 Session
Presentation Type: Podium