Dataset Information

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.

ABSTRACT:

Objectives

To determine the disease-free survival (DFS), disease-specific survival (DSS), and recurrence in patients who underwent laparoscopic low anterior rectal resection with total mesorectal excision (TME) with either high or low ligation of the inferior mesenteric artery (IMA).

Background

The level of IMA ligation during anterior rectal resection with TME is still a matter of debate, especially in terms of oncological adequacy.

Methods

Between June 2014 and December 2016, patients scheduled to undergo elective laparoscopic low anterior resection (LAR) and TME in 6 Italian nonacademic hospitals were randomized into 2 groups in the HIGHLOW Trial (ClinicalTrials.gov Identifier: NCT02153801) according to the level of IMA ligation: high ligation (HL) versus low ligation (LL). DFS, DSS, and recurrence were inquired. Recurrence was determined at 3, 6, 9, and 12 months and every 6 months thereafter. Patients and tumor characteristics as well as surgical outcomes were analyzed to identify risk factors for recurrence.

Results

One hundred ninety-six patients from the HIGHLOW trial were analyzed. Median follow-up for DFS was 40.6 (interquartile range [IQR], 6-64.7) and 40 (IQR, 7.6-67.8), while median follow-up for DSS was 41.2 (IQR, 10.7-64.7) and 42.7 (IQR, 6-67.6) in the HL and LL groups, respectively. The 3-year DFS rate of HL and LL patients was 82.2% and 82.1% (P = 0.874), respectively. The 3-year DSS for HL and LL patients was 92.1% and 93.4% (P = 0.897), respectively. There was no statistically significant difference in the local recurrence rate (2% HL vs 2.1% LL), in the regional recurrence rate (3% HL vs 2.1% LL), and in the distant recurrence rate (12.9% HL vs 13.7% LL). Multivariate analysis found conversion to open surgery (hazard ratio [HR], 3.68; P = 0.001) and higher stage of disease (HR, 7.73; P < 0.001) to be significant determinant for DFS.

Conclusions

The level of inferior mesenteric artery ligation during LAR and TME for rectal cancer does not affect DFS, DSS, and recurrence.

SUBMITTER: Mari GM

PROVIDER: S-EPMC10455194 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

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.

Mari Giulio M GM Crippa Jacopo J Achilli Pietro P Montroni Isacco I Ugolini Giampaolo G Taffurelli Giovanni G Cocozza Eugenio E Borroni Giacomo G Valenti Francesco F Roscio Francesco F Ferrari Giovanni G Origi Matteo M Zuliani Walter W Pugliese Raffaele R Costanzi Andrea T M ATM Fingherut Abe A Maggioni Dario D

Annals of surgery open : perspectives of surgical history, education, and clinical approaches 20201019 2

<h4>Objectives</h4>To determine the disease-free survival (DFS), disease-specific survival (DSS), and recurrence in patients who underwent laparoscopic low anterior rectal resection with total mesorectal excision (TME) with either high or low ligation of the inferior mesenteric artery (IMA).<h4>Background</h4>The level of IMA ligation during anterior rectal resection with TME is still a matter of debate, especially in terms of oncological adequacy.<h4>Methods</h4>Between June 2014 and December 2 ...[more]

PMID: 37637440

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Project description:ObjectiveThe aim of this systematic review and meta-analysis is to summarize the current scientific evidence regarding the impact of the level of inferior mesenteric artery (IMA) ligation on post-operative and oncological outcomes in rectal cancer surgery.MethodsWe conducted a systematic review of the literature up to 06 September 2022. Included were RCTs that compared patients who underwent high (HL) vs. anterior (LL) IMA ligation for resection of rectal cancer. The literature search was performed on Medline/PubMed, Scopus, and the Web of Science without any language restrictions. The primary endpoint was overall anastomotic leakage (AL). Secondary endpoints were oncological outcomes, intraoperative complications, urogenital functional outcomes, and length of hospital stay.ResultsEleven RCTs (1331 patients) were included. The overall rate of AL was lower in the LL group, but the difference was not statistically significant (RR 1.43, 95% CI 0.95 to 2.96). The overall number of harvested lymph nodes was higher in the LL group, but the difference was not statistically significant (MD 0.93, 95% CI - 2.21 to 0.34). The number of lymph nodes harvested was assessed in 256 patients, and all had a laparoscopic procedure. The number of lymph nodes was higher when LL was associated with lymphadenectomy of the vascular root than when IMA was ligated at its origin, but there the difference was not statistically significant (MD - 0.37, 95% CI - 1.00 to 0.26). Overall survival at 5 years was slightly better in the LL group, but the difference was not statistically significant (RR 0.98, 95% CI 0.93 to 1.05). Disease-free survival at 5 years was higher in the LL group, but the difference was not statistically significant (RR 0.97, 95% CI 0.89 to 1.04).ConclusionsThere is no evidence to support HL or LL according to results in terms of AL or oncologic outcome. Moreover, there is not enough evidence to determine the impact of the level of IMA ligation on functional outcomes. The level of IMA ligation should be chosen case by case based on expected functional and oncological outcomes.

Project description: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: NCT02153801 Protocol Registration Receipt 29/5/2014.

Dataset Information

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.

Objectives

Background

Methods

Results

Conclusions

Publications

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.

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