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Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial.

ABSTRACT: BACKGROUND:Total Mesorectal Excision (TME) is the standard surgical technique for the treatment of rectal cancer. However, rates of sexual dysfunction ofup to 50% have been described after TME, and rates of urinary dysfunction of up to 30%. Although other factors are involved, the main cause of postoperative genitourinary dysfunction is intraoperative injury to the pelvic autonomic nerves. The risk is particularly high in the inferior mesenteric artery (IMA). The aim of this study is to compare pre- and post-TME sexual dysfunction, depending on the surgical approach usedin the inferior mesenteric vessels: either directly on the IMA, or from the inferior mesenteric vein (IMV) to the IMA. METHODS:Prospective, randomized,controlled study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomly assigned to one of two groups depending on the surgical approach to the inferior mesenteric vessels. The main variable is pre- and postoperative sexual dysfunction; secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, and pre- and postoperative quality of life. The sample will comprise 90 patients, 45 per group. DISCUSSION:The aim is to demonstrate that the dissection route from the IMV towards the IMA favors the preservation of the pelvic autonomic nerves and thus reducesrates of sexual dysfunction post-surgery. TRIAL REGISTRATION:Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 017/315. ClinicalTrials.gov TAU-RECTALNERV-PRESERV-2018 (TRN: NCT03520088 ) (Date of registration 04/03/2018).

SUBMITTER: Pallisera-Lloveras A

PROVIDER: S-EPMC6683580 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial.

Pallisera-Lloveras Anna A Planelles-Soler Paula P Hannaoui Naim N Mora-López Laura L Muñoz-Rodriguez Jesús J Serra-Pla Sheila S Dominguez-Garcia Arturo A Prats-López Joan J Navarro-Soto Salvador S Serra-Aracil Xavier X

BMC urology 20190805 1

<h4>Background</h4>Total Mesorectal Excision (TME) is the standard surgical technique for the treatment of rectal cancer. However, rates of sexual dysfunction ofup to 50% have been described after TME, and rates of urinary dysfunction of up to 30%. Although other factors are involved, the main cause of postoperative genitourinary dysfunction is intraoperative injury to the pelvic autonomic nerves. The risk is particularly high in the inferior mesenteric artery (IMA). The aim of this study is to ...[more]

PMID: 31382934

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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:Background and Objectives: This study aimed to compare the effects of high ligation (HL) versus low ligation (LL) in colorectal cancer surgery. Materials and Methods: We performed a comprehensive search using multiple databases (trial registries and ClinicalTrials.gov), other sources of grey literature, and conference proceedings, with no restrictions on the language or publication status, up until 10 March 2021. We included all parallel-group randomized controlled trials (RCTs) and considered cluster RCTs for inclusion. The risk of bias domains were "low risk," "high risk," or "unclear risk." We performed statistical analyses using a random-effects model and interpreted the results according to the Cochrane Handbook for Systematic Reviews of Interventions. We used the GRADE guidelines to rate the certainty of evidence (CoE) of the randomized controlled trials. Results: We found 12 studies (24 articles) from our search. We were very uncertain about the effects of HL on overall mortality, disease recurrence, cancer-specific mortality, postoperative mortality, and anastomotic leakage (very low CoE). There may be little to no difference between HL and LL in postoperative complications (low CoE). For short-term follow-up (within 6 months), HL may reduce defecatory function (constipation; low CoE). While HL and LL may have similar effects on sexual function in men, HL may reduce female sexual function compared with LL (low CoE). For long-term follow-up (beyond 6 months), HL may reduce defecatory function (constipation; low CoE). There were discrepancies in the effects regarding urinary dysfunction according to which questionnaire was used in the studies. HL may reduce male and female sexual function (low CoE). Conclusions: We are very uncertain about the effects of HL on survival outcomes, and there is no difference in the incidence of postoperative complications between HL and LL. More rigorous RCTs are necessary to evaluate the effect of HL and LL on functional outcomes.

Project description:ObjectivesTo 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).BackgroundThe level of IMA ligation during anterior rectal resection with TME is still a matter of debate, especially in terms of oncological adequacy.MethodsBetween 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.ResultsOne 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.ConclusionsThe level of inferior mesenteric artery ligation during LAR and TME for rectal cancer does not affect DFS, DSS, and recurrence.

Dataset Information

Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial.

Publications

Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial.

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