title: "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial).
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014.
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. giul_mari@yahoo.it.
authors.forename: Giulio
authors.initials: G
authors.lastname: Mari
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. dario.maggioni@aovimercate.org.
authors.forename: Dario
authors.initials: D
authors.lastname: Maggioni
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. andrea.costanzi@aovimercate.org.
authors.forename: Andrea
authors.initials: A
authors.lastname: Costanzi
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. angelo.Miranda@aovimercate.org.
authors.forename: Angelo
authors.initials: A
authors.lastname: Miranda
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. rigamonti.luca@gmail.com.
authors.forename: Luca
authors.initials: L
authors.lastname: Rigamonti
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. jack0510@icloud.com.
authors.forename: Jacopo
authors.initials: J
authors.lastname: Crippa
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. carmelo.magistro@ospedaleniguarda.it.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Magistro
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. stefano.dilernia@ospedaleniguarda.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Di Lernia
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. antonello.forgione@ospedaleniguarda.it.
authors.forename: Antonello
authors.initials: A
authors.lastname: Forgione
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. pietrocarne@gmail.com.
authors.forename: Pietro
authors.initials: P
authors.lastname: Carnevali
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. michele.nichelatti@ospedaleniguarda.it.
authors.forename: Michele
authors.initials: M
authors.lastname: Nichelatti
authors.affiliation: Dipartimento di Chirurgia Generale, AO Provincia di Lecco, Ospedale di Merate, Lecco, Italy. p.carzaniga@ospedale.lecco.it.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Carzaniga
authors.affiliation: Dipartimento di Chirurgia Generale, AO Provincia di Lecco, Ospedale di Merate, Lecco, Italy. francescovalenti2004@libero.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Valenti
authors.affiliation: Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy. m.rovagnati@ospedale.lecco.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Rovagnati
authors.affiliation: Dipartimento di Chirurgia Generale, Ospedale di Circolo di Varese, Varese, Italy. mattia.berselli@ospedale.varese.it.
authors.forename: Mattia
authors.initials: M
authors.lastname: Berselli
authors.affiliation: Dipartimento di Chirurgia Generale, Ospedale di Circolo di Varese, Varese, Italy. eugenio.cocozza@ospedale.varese.it.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Cocozza
authors.affiliation: Dipartimento di Chirurgia Generale, Ospedale di Circolo di Varese, Varese, Italy. Lorenzo.livraghi@ospedale.varese.it.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Livraghi
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. matteo.origin@gmail.com.
authors.forename: Matteo
authors.initials: M
authors.lastname: Origi
authors.affiliation: Dipartimento di Chirurgia Generale, AO Busto Arsizion, Ospedale di Tradate, Tradate, Italy. iscandroglio@aobusto.it.
authors.forename: Ildo
authors.initials: I
authors.lastname: Scandroglio
authors.affiliation: Dipartimento di Chirurgia Generale, AO Busto Arsizion, Ospedale di Tradate, Tradate, Italy. froscio@aobusto.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Roscio
authors.affiliation: Dipartimento di Chirurgia Generale, AO Busto Arsizion, Ospedale di Tradate, Tradate, Italy. adeluca@aobusto.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: De Luca
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. giovanni.ferrari@ospedaleniguarda.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Ferrari
authors.affiliation: Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy. raffaele.pugliese@ospedaleniguarda.it.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Pugliese
mesh_terms: D057868:Anastomotic Leak / Q000453:epidemiology; D002985:Clinical Protocols; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008026:Ligation; D017537:Mesenteric Artery, Inferior / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology; D012004:Rectal Neoplasms / Q000601:surgery*; D012007:Rectum / Q000601:surgery*; D018401:Sample Size