"High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial).

Giulio Mari,Lorenzo Livraghi,Raffaele Pugliese,Matteo Origi,Michele Nichelatti,Pietro Carnevali,Pierluigi Carzaniga,Mattia Berselli,Francesco Roscio,Antonio De Luca,Ildo Scandroglio,Jacopo Crippa,Dario Maggioni,Carmelo Magistro,Giovanni Ferrari,Andrea Costanzi,Stefano Di Lernia,Marco Rovagnati,Antonello Forgione,Eugenio Cocozza,Angelo Miranda,Francesco Valenti,L Rigamonti

doi:10.1186/s13063-014-0537-5

Abstract

BackgroundThe position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial.Methods/designThe HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, β = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients.DiscussionThe HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function.Trial registrationClinicalTrials.gov Identifier: NCT02153801Protocol Registration Receipt 29/5/2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-014-0537-5) contains supplementary material, which is available to authorized users.

Highlights

The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage
The aim of this study is to compare the incidence of genito-urinary dysfunction and, secondarily, the incidence of anastomotic leakage and the oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial
The risk of poor blood supply of the anastomosis could outweigh the oncological benefits of performing high ligation of the inferior mesenteric artery routinely, on the other hand a more powerful disease staging achieved with high ligation of the inferior mesenteric artery is found to be associated with an acceptable anastomotic leak rate

Summary

Introduction

The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial. The introduction of total mesorectal excision [2], neo-adjuvant therapy protocols [3], and the laparoscopic approach [4] has made rectal cancer treatment a multidisciplinary management. The laparoscopic treatment of rectal cancer raises specific issues related to its anatomical location: difficult exposure in a narrow pelvis, challenging nerve-sparing techniques, low intestinal transection, and total mesorectal excision [6,7]. The need for well-designed studies to compare the different vascular approaches in rectal surgery has been clearly expressed [12,13,14]

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