Project description:BackgroundThe level of inferior mesenteric artery (IMA) ligation for anterior resection of rectal cancer has several considerations concerning oncological outcomes. The primary endpoint of this randomized controlled trial (RCT) was to assess bowel function between high and low ligation. This study was intended to clarify oncological outcome as the secondary endpoint.ObjectiveThe aim of this study was to assess in a prospective RCT whether the ligation level of the IMA in rectal cancer influences oncological outcomes.MethodsBetween February 2008 and December 2011, 100 patients who underwent anterior resection for rectal cancer were randomized to perform either high or low ligation of the IMA. Oncological outcomes was the secondary endpoint of this RCT, whereas assessing bowel function was the primary endpoint. This RCT was registered at clinicaltrials.gov (NCT00701012).ResultsThere were no differences between the groups in terms of clinical data except for tumor stage. There were more advanced-stage patients in the high ligation group (p = 0.046). There were no lymph node (LN) metastases in the root of the IMA in the high ligation group. The average number of harvested LNs for the high and low ligation groups was 16.7 and 14.9, respectively. There was no difference in disease-free survival (DFS), site of first recurrence, and overall survival (OS). When patients were in stage III, there was also no difference in DFS and OS.ConclusionsThe ligation level of the IMA in rectal cancer may not influence oncological outcomes. However, further large-scale RCTs are needed to conclude this issue.
Project description:BackgroundThe optimal level for inferior mesenteric artery ligation during anterior resection for rectal cancer is controversial. The aim of this randomized trial was to clarify whether the inferior mesenteric artery should be tied at the origin (high tie) or distal to the left colic artery (low tie).MethodsPatients were allocated randomly to undergo either high- or low-tie ligation and were stratified by surgical approach (open or laparoscopic). The primary outcome was the incidence of anastomotic leakage. Secondary outcomes were duration of surgery, blood loss and 5-year overall survival.ResultsSome 331 patients entered the trial between June 2006 and September 2012. The trial was stopped prematurely as recruitment was slow. Seven patients were excluded after randomization but before operation because of procedural changes. High tie and low tie were performed in 164 and 160 patients respectively. The incidence of anastomotic leakage was not significantly different (17·7 versus 16·3 per cent respectively; P = 0·731). The incidence of severe complications requiring intervention was 2·4 versus 5·0 per cent for high and low tie respectively (P = 0·222). In multivariable analysis, risk factors for anastomotic leakage included male sex (odds ratio 4·36, 95 per cent c.i. 1·56 to 12·18) and distance of the tumour from the anal verge (odds ratio 0·99, 0·98 to 1·00). At 5 years there were no significant differences in overall (87·2 versus 89·4 per cent respectively; P = 0·386) and disease-free (76·3 versus 77·6 per cent; P = 0·765) survival.ConclusionThe level of ligation of the inferior mesenteric artery does not significantly influence the rate of anastomotic leakage. Registration number: NCT01861678 ( https://clinicaltrials.gov).
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.
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:BackgroundWhether high or low ligation of the inferior mesenteric artery (IMA) is superior in surgery for rectal and sigmoid colon cancers remains controversial. Although several meta-analyses have been conducted, the level of lymph node clearance was poorly defined. We performed a meta-analysis comparing high and low ligation of the IMA for sigmoid colon and rectal cancers, with emphasis on high dissection of the lymph node at the IMA root in all the included studies.MethodsPubMed, MEDLINE, and EMBASE databases were searched to identify relevant articles published until 2020. The patient's perioperative and oncologic outcomes were analyzed. Statistical analysis was performed using the statistical software RevMan version 5.4.ResultsA total of 17 studies, including four randomized controlled trials, published between 2011 and 2020 were selected. In total, 1,846 patients received low ligation of the IMA plus high dissection of lymph nodes (LL+HD), and 2,648 patients received high ligation of the IMA (HL). LL+HD was associated with low incidence of anastomotic leakage (p < 0.001), borderline long operative time (p = 0.06), and less yields of total lymph nodes (p = 0.03) but equivalent IMA root lymph nodes (p = 0.07); moreover, LL+HD exhibited non-inferior long-term oncological outcomes.ConclusionIn comparison with HL, LL+HD was an effective and safe oncological procedure for sigmoid colon and rectal cancers. Therefore, to ligate the IMA below the level of the left colic artery with D3 high dissection for sigmoid colon and rectal cancers might be suggested once the surgeons are familiar with this technique.Systematic review registrationINPLASY.com, identifier 202190029.
Project description:PurposeTo investigate the relationship between the left trunk of the inferior mesenteric plexus (IMP) and the vascular sheath of the inferior mesenteric artery (IMA) and to explore anatomical evidence for autonomic nerve preservation during high ligation of the IMA in colorectal cancer surgery.MethodsWe evaluated the relationship in 23 consecutive cases of laparoscopic or robotic colorectal surgery with high ligation of the IMA at our institute. Anatomical dissection was performed on 5 formalin-fixed abdominal specimens. A novel anatomical evidence-based operative technique was proposed.ResultsAnatomical observation showed that the left trunk of the IMP was closely connected with the IMA and was involved in the composition of the vascular sheath. Based on anatomical evidence, we present a novel operative technique for nerve-sparing high ligation of the IMA that was successfully performed in 45 colorectal cancer surgeries with no intraoperative complications and satisfactory postoperative urogenital functional outcomes.ConclusionThe left trunk of the IMP is involved in the composition of the IMA vascular sheath. This novel anatomical evidence-based operative technique for nerve-sparing high ligation of the IMA is technically safe and feasible.
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.
Project description:Interventions: A:low tie of IMA, preserve LCA;B:high tie of IMA, not preserve LCA
Primary outcome(s): Operation time;The total of hemorrhages quantities;The time of break wind after the operation;The number and positive rate of IMA vascular root lymph node;disease rate after the operation
Study Design: Randomized parallel controlled trial
Project description:BackgroundAlthough many efforts have been made to decrease the incidence of anastomotic leak (AL), it remains one of the most serious complications of rectal cancer surgery. Many previous studies have reported an association between the ligation level of the inferior mesenteric artery (IMA) (high or low) and the incidence of AL after rectal cancer surgery. However, we cannot draw a solid conclusion because of the low quality and heterogeneity of those studies. Therefore, this study aims to investigate the impact of the IMA ligation level on the occurrence of AL after minimally invasive anterior resection of rectal cancer.Methods/designPatients with primary rectal cancer without distant metastases will be included after screening. They will be randomly assigned (1:1) to receive high or low ligation of the IMA. The primary endpoint is AL incidence; secondary endpoints are quality of life; urinary, sexual, and defecatory functions; and 3-year disease-free survival. We hypothesized that the incidence rate of AL would be 15% and 5% in the high- and low-ligation groups, respectively. With a two-sided α of 0.05 and a power of 0.8, the sample size is calculated to be 314 patients (157 per group), considering a 10% dropout rate.DiscussionAlthough many studies have compared the short- and long-term outcomes of high and low ligation of the IMA in rectal cancer surgery, it is still debatable. This trial aims to help draw a more solid conclusion regarding the association between the IMA ligation level and AL incidence after rectal cancer surgery. We also hope to contribute to standardizing the method of rectal cancer surgery in this trial.Trial registrationClinical Research Information Service KCT0003523. Registered on February 18, 2019.