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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization; Procedure: Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization

• Registration Number: NCT03895255
• Lead Sponsor: Russian Society of Colorectal Surgeons

Brief 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

Study Timeline

• Study Start: 2016-10-02
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-03-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-27
• Primary Completion: 2020-05-02
• Study Completion: 2021-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Histologically proven primary rectal adenocarcinoma located within 15 cm from anal verge not involving internal and/or external sphincter muscle
2. Stage I-III
3. Elective surgical treatment with TME and primary colorectal anastomosis
4. Receive or not receive neoadjuvant radio-chemotherapy
5. Overall health status according to American Society of Anesthesiologists (ASA) classification: I-III
6. Signed informed consent with agreement to attend all study visits
7. The patient is not pregnant

Exclusion Criteria

1. Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection
2. The patient wants to withdraw from the clinical trial
3. Loss to follow-up
4. Inability to complete all the trial procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMA skeletonization and low ligation with selective SFM	Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization	Inferior mesenteric artery is ligated below the origin of left colic artery. Splenic flexure is mobilized only if needed.
IMA high ligation with routine SFM	Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization	Inferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized.

Primary Outcome Measures

Name	Time	Method
Anastomotic Leakage Rate	4-6 weeks	The rate of symptomatic and asymptomatic colorectal anastomotic leakage

Secondary Outcome Measures

Name	Time	Method
IMA architectonics	1 day	The incidence of left colic artery, first, second and third sigmoid arteries
Early postoperative complications rate	30 days	The rate of complications in first 30 days after surgery
Conversion rate	1 day	The rate of conversion from laparoscopic or robotic approach to open approach
Splenic flexure mobilization rate	1 day	The rate of splenic flexure mobilization in Low tie group
Complications of defunctioning stoma	3 month	Any complications of defunctioning stoma
Operating time	1 day	The duration of surgical procedure
Positive Apical Lymph Nodes Rate	30 days	The rate of metastatic lymph nodes found in the area of paraaortic lymph node dissection
Intraoperative complications rate	1 day	The rate of complications during surgery
The postoperative hospital stay	1 month	the number of days from the first day after operation to discharge
The length of IMA trunk	1 day	the length of inferior mesenteric artery trunk based on preoperative CT-scans and intraoperative findings
Specimen morphometry	30 days	The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length

Trial Locations

Locations (1)

Clinic of Colorectal and Minimally Invasive Surgery; 🇷🇺 Moscow, Russian Federation