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

• Sponsor: Russian Society of Colorectal Surgeons (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03895255
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 61
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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%).

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Procedure: Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization; Procedure: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Oct 2, 2016
• Anticipated Primary Completion Date: May 2, 2020
• Anticipated Study Completion Date: Nov 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IMA high ligation with routine SFM Inferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized.	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.; Other Names: High tie with routine SFM
Experimental: IMA skeletonization and low ligation with selective SFM Inferior mesenteric artery is ligated below the origin of left colic artery. Splenic flexure is mobilized only if needed.	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.; Other Names: Low tie with selective SFM

Outcome Measures

Primary Outcome Measures

1. Anastomotic Leakage Rate [4-6 weeks]

   The rate of symptomatic and asymptomatic colorectal anastomotic leakage

Secondary Outcome Measures

1. Operating time [1 day]

   The duration of surgical procedure

2. Intraoperative complications rate [1 day]

   The rate of complications during surgery

3. Splenic flexure mobilization rate [1 day]

   The rate of splenic flexure mobilization in Low tie group

4. Conversion rate [1 day]

   The rate of conversion from laparoscopic or robotic approach to open approach

5. IMA architectonics [1 day]

   The incidence of left colic artery, first, second and third sigmoid arteries

6. The length of IMA trunk [1 day]

   the length of inferior mesenteric artery trunk based on preoperative CT-scans and intraoperative findings

7. Early postoperative complications rate [30 days]

   The rate of complications in first 30 days after surgery

8. Specimen morphometry [30 days]

   The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length

9. Positive Apical Lymph Nodes Rate [30 days]

   The rate of metastatic lymph nodes found in the area of paraaortic lymph node dissection

10. Complications of defunctioning stoma [3 month]

    Any complications of defunctioning stoma

11. The postoperative hospital stay [1 month]

    the number of days from the first day after operation to discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic of Colorectal and Minimally Invasive Surgery	Moscow		Russian Federation	119435

Sponsors and Collaborators

• Russian Society of Colorectal Surgeons

Investigators

• Principal Investigator: Petr Tsarkov, Prof, Russian Society of Colorectal Surgeons

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Russian Society of Colorectal Surgeons
• ClinicalTrials.gov Identifier: NCT03895255
• Other Study ID Numbers: 683472
• First Posted: Mar 29, 2019
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Russian Society of Colorectal Surgeons: lymph node dissection; high tie; low tie; splenic flexure mobilization; anastomotic leak
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Feb 27, 2020