Trial reportTrials2015
"High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial).
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Sexual Urinary Function in Patients Undergoing Laparoscopic Low Anterior Resection With Total Mesorectal Excision With High Or Low Ligation of the Inferior Mesenteric Artery With Preservation of Left Colic Artery Multicentre Randomized Trial
Low or High Ligation of the Inferior Mesenteric Artery With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial (LAND)
Randomized Controlled Trial: Clinical Value of Preserving Left Colic Artery in Laparoscopic Radical Rectectomy
Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Surgical Anatomy of the Superior Mesenteric Vessels Related to Pancreaticoduodenectomy: a Systematic Review and Meta-Analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2018Pooled it
- Optimum level of inferior mesenteric artery ligation for the left-sided colorectal cancer. Systematic review for high and low ligation continuum.Saudi medical journal · 2016Pooled it
- Comparison of a robotic surgery program for rectal cancer: short- and long-term results from a comparative, retrospective study between two laparoscopic and robotic reference centers.Surgical endoscopy · 2024Article
- A nomogram for predicting lymph nodes metastasis at the inferior mesenteric artery in rectal cancer: a retrospective case-control study.Updates in surgery · 2024Article
- Short-Term and Long-Term Outcomes in Mid and Low Rectal Cancer With Robotic Surgery.Frontiers in oncology · 2021Article
- High Versus Low Ligation of the Inferior Mesenteric Artery During Rectal Resection for Cancer: Oncological Outcomes After Three Years of Follow-Up From the HIGHLOW Trial.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2020Article
- Vascular anatomy of inferior mesenteric artery in laparoscopic radical resection with the preservation of left colic artery for rectal cancer.World journal of gastroenterology · 2018Article
- Randomized clinical trial of high versus low inferior mesenteric artery ligation during anterior resection for rectal cancer.BJS open · 2018Article
- Three-dimensional reconstruction of the vascular arrangement including the inferior mesenteric artery and left colic artery in laparoscope-assisted colorectal surgery.Surgical endoscopy · 2016Article
- A prospective study of sexual and urinary function before and after total mesorectal excision.International journal of colorectal disease · 2016Article
- Assessment of lymph node involvement in colorectal cancer.World journal of gastrointestinal surgery · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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. 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 registrationClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.