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

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.

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%).

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arcangelo Picciariello, MD; Phone Number: +393492185104; Email: picciariello@kkmx.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Recruiting
    • Clinic of Colorectal and Minimally Invasive Surgery
    • Principal Investigator: Petr Tsarkov, Prof
    • Sub-Investigator: Inna Tulina, MD
    • Sub-Investigator: Victor Zhurkovsky, MD
    • Sub-Investigator: Lyudmila Sidorova, MD
    • Sub-Investigator: Arcangelo Picciariello, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic Leakage Rate	The rate of symptomatic and asymptomatic colorectal anastomotic leakage	4-6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons

Publications and helpful links

General Publications

• Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.
• Ho YH. Techniques for restoring bowel continuity and function after rectal cancer surgery. World J Gastroenterol. 2006 Oct 21;12(39):6252-60. doi: 10.3748/wjg.v12.i39.6252.
• Kanemitsu Y, Hirai T, Komori K, Kato T. Survival benefit of high ligation of the inferior mesenteric artery in sigmoid colon or rectal cancer surgery. Br J Surg. 2006 May;93(5):609-15. doi: 10.1002/bjs.5327.
• Lange MM, Buunen M, van de Velde CJ, Lange JF. Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A review. Dis Colon Rectum. 2008 Jul;51(7):1139-45. doi: 10.1007/s10350-008-9328-y. Epub 2008 May 16.
• Mouw TJ, King C, Ashcraft JH, Valentino JD, DiPasco PJ, Al-Kasspooles M. Routine splenic flexure mobilization may increase compliance with pathological quality metrics in patients undergoing low anterior resection. Colorectal Dis. 2019 Jan;21(1):23-29. doi: 10.1111/codi.14404. Epub 2018 Sep 29.
• Katory M, Tang CL, Koh WL, Fook-Chong SM, Loi TT, Ooi BS, Ho KS, Eu KW. A 6-year review of surgical morbidity and oncological outcome after high anterior resection for colorectal malignancy with and without splenic flexure mobilization. Colorectal Dis. 2008 Feb;10(2):165-9. doi: 10.1111/j.1463-1318.2007.01265.x. Epub 2007 May 16.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2016
• Primary Completion (Anticipated): May 2, 2020
• Study Completion (Anticipated): November 2, 2021

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: anastomotic leak; lymph node dissection; high tie; low tie; splenic flexure mobilization
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 683472

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No