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Randomized Controlled Trial
. 2015 Jan 27:16:21.
doi: 10.1186/s13063-014-0537-5.

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

Giulio Mari  1 , Dario Maggioni  2 , Andrea Costanzi  3 , Angelo Miranda  4 , Luca Rigamonti  5 , Jacopo Crippa  6 , Carmelo Magistro  7 , Stefano Di Lernia  8 , Antonello Forgione  9 , Pietro Carnevali  10 , Michele Nichelatti  11 , Pierluigi Carzaniga  12 , Francesco Valenti  13 , Marco Rovagnati  14 , Mattia Berselli  15 , Eugenio Cocozza  16 , Lorenzo Livraghi  17 , Matteo Origi  18 , Ildo Scandroglio  19 , Francesco Roscio  20 , Antonio De Luca  21 , Giovanni Ferrari  22 , Raffaele Pugliese  23
Affiliations
Randomized Controlled Trial

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

Giulio Mari et al. Trials. .

Abstract

Background: 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. 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/design: The 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.

Discussion: The 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 registration: ClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014.

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Figures

Figure 1
Figure 1
Study flowchart. LAR: Laparoscopic Anterior Resection. TME: Total Mesorectal Excision.
See this image and copyright information in PMC

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