Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

NCT02279771 | Unknown

• 1 other identifier: Siccr/2014
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy

Conditions

Rectal Cancer

Keywords

colorectal anastomosis; anastomotic leak; ileostomy; complications

Outcome Measures

Primary Outcomes (1)

• anastomotic leak

  anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis

  30 postoperative days

Secondary Outcomes (2)

• duration of the two operations

  Intraoperative

• Number of overall postoperative complications

  30 postoperative days

Study Arms (2)

transanal anastomotic reinforcement

ACTIVE COMPARATOR

Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)

Procedure: transanal anastomotic reinforcement; Device: a circular anal dilator (CAD)

protective ileostomy group

ACTIVE COMPARATOR

Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)

Procedure: protective ileostomy group

Interventions

transanal anastomotic reinforcement PROCEDURE

a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired. Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.

transanal anastomotic reinforcement

protective ileostomy group PROCEDURE

S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.

protective ileostomy group

a circular anal dilator (CAD) DEVICE

Epo Flier, SapiMed SPA, Alessandria, Italy

transanal anastomotic reinforcement

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resectable, histologically proven primary adenocarcinoma of the medium-low rectum without internal and/or external sphincter muscle involvement.
• Distal margin of the tumor at least 6 cm form the anal verge
• Staged as follows prior to neoadjuvant chemoradiation:
• Stage T2 - T4 at MRI N0-2 at MRI M0/M1 at CT scan Patient classified T3-T4 must undergo neoadjuvant chemoradiation with at least 8 weeks delay of surgery

You may not qualify if:

• Squamous cell carcinoma
• Adenocarcinoma Stage T1,
• T4 with one of the following:
• with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total)
• Unresectable primary rectal cancer or Inability to complete R0 resection.
• Rectal cancer under 6 cm from the anal verge requiring colo-anal anastomosis
• Recurrent rectal cancer
• Previous pelvic malignancy
• Inability to sign informed consent
• Pregnancy

Sponsors & Collaborators

• Donato F Altomare: lead

Study Sites (1)

Unknown Facility

Bari, 70100, Italy

RECRUITING

Related Publications (21)

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• Baek SJ, Kim J, Kwak J, Kim SH. Can trans-anal reinforcing sutures after double stapling in lower anterior resection reduce the need for a temporary diverting ostomy? World J Gastroenterol. 2013 Aug 28;19(32):5309-13. doi: 10.3748/wjg.v19.i32.5309.

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  PMID: 24791631 BACKGROUND

• Altomare DF, Delrio P, Shelgyn Y, Rybakov E, Vincenti L, De Fazio M, Simone M, Graziano G, Picciariello A. Transanal reinforcement of low rectal anastomosis versus protective ileostomy after total mesorectal excision for rectal cancer. Preliminary results of a randomized clinical trial. Colorectal Dis. 2021 Jul;23(7):1814-1823. doi: 10.1111/codi.15685. Epub 2021 May 10.

  PMID: 33891798 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arcangelo Picciariello, MD

  Societa Italiana di Chirurgia ColoRettale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donato F Altomare, MD

CONTACT

3397593066; donatofrancesco.altomare@uniba.it

Maria Di Lena, MD

CONTACT

+390805592107; mariadilena@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: January 1, 2015
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

IT (1)