NCT03895255

Selective sPlenic flExure Mobilization for Low colorEctal Anastomosis After D3 lYmph Node Dissection (Speedy Trial)

Randomized Non-inferiority Trial of Selective Splenic Flexure Mobilization for the Formation of Low Colorectal Anastomosis After Total Mesorectal Excision and D3 Paraaortic Lymph Node Dissection in Low Rectal Cancer.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Russian Society of Colorectal Surgeons · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated. The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular sheath of inferior mesenteric artery (IMA) in low anterior resection of the rectum for cancer. This study purpose to demonstrate that low IMA ligation, sparing of left colic artery (LCA) and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%).

Detailed description

Although TME is the standard curative operation for rectal cancer patients, who undergo low anterior resection (LAR) or abdominoperineal resection (APR) with a permanent colostomy, the strategy to restore the transit between colon and rectum (in case of LAR) is still debated in literature. Several studies comparing high-tie with low-tie ligation reported a stage-specific survival benefit for high-tie, but on the other hand recent studies demonstrated that low-tie, without splenic flexure mobilization (SFM), decreases the complexity of the laparoscopic procedure and could reduces the operating time with comparable oncological outcomes. The method of restorative surgery, after Total Mesorectal Excision (TME), largely depends on the length of the resected part of the colon, that is related to patient's anatomical features and the height of vascular ligation performed during the operation. In attempt to perform a radical paraaortic lymph node dissection the inferior mesenteric artery (IMA) is usually ligated at its origin and the Arcade of Riolan provides bloody supply to any distal anastomosis. Unfortunately the Arcade of Riolan is an inconstant finding and sometimes (26% of cases) is mandatory to mobilize the splenic flexure to ensure a safe and tension-free anastomosis. SFM is a time-consuming component of LAR, has the additional risk of iatrogenic splenic injury and is very difficult during a laparoscopic resection. In 2005 was demonstrated that routine SFM is not always necessary during anterior resection for rectal cancer. A recent retrospective analysis by Mouw showed that SFM was associated with wider margins and a decreased rate of inadequate nodal staging in patients undergoing LAR. This trial aims to demonstrate that low IMA ligation, sparing of LCA and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%). Furthermore this study purpose to evaluate the need to perform splenic flexure mobilization (SFM) in low ligation group and the, operation time, apical lymph nodes positive rate and short terms postoperative complication in both groups

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization	Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized. Side-to-end sigmoido-rectal anastomosis is created.
PROCEDURE	Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization	Nerve-sparing paraaortic lymph node dissection is performed. Then inferior mesenteric artery is skeletonized down to the origin of left colic artery and divided below it. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized only if sigmoid colon is unsuitable for anastomosis or doesn't reach the rectal stump. Then descending-rectal side-to-end anastomosis is created.

Timeline

• Start date: 2016-10-02
• Primary completion: 2020-05-02
• Completion: 2021-11-02
• First posted: 2019-03-29
• Last updated: 2020-02-27

Locations

1 site across 1 country: Russia