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%).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
142
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.
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.
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, Russia
RECRUITINGAnastomotic Leakage Rate
The rate of symptomatic and asymptomatic colorectal anastomotic leakage
Time frame: 4-6 weeks
Operating time
The duration of surgical procedure
Time frame: 1 day
Intraoperative complications rate
The rate of complications during surgery
Time frame: 1 day
Splenic flexure mobilization rate
The rate of splenic flexure mobilization in Low tie group
Time frame: 1 day
Conversion rate
The rate of conversion from laparoscopic or robotic approach to open approach
Time frame: 1 day
IMA architectonics
The incidence of left colic artery, first, second and third sigmoid arteries
Time frame: 1 day
The length of IMA trunk
the length of inferior mesenteric artery trunk based on preoperative CT-scans and intraoperative findings
Time frame: 1 day
Early postoperative complications rate
The rate of complications in first 30 days after surgery
Time frame: 30 days
Specimen morphometry
The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
Time frame: 30 days
Positive Apical Lymph Nodes Rate
The rate of metastatic lymph nodes found in the area of paraaortic lymph node dissection
Time frame: 30 days
Complications of defunctioning stoma
Any complications of defunctioning stoma
Time frame: 3 month
The postoperative hospital stay
the number of days from the first day after operation to discharge
Time frame: 1 month
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