Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery (LessStoReS)

Donato F Altomare

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: transanal anastomotic reinforcement; Procedure: protective ileostomy group; Device: a circular anal dilator (CAD)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02279771

Siccr/2014

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

transanal anastomotic reinforcement

Active Comparator group

Description:

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

Treatment:

Procedure: transanal anastomotic reinforcement

Device: a circular anal dilator (CAD)

protective ileostomy group

Active Comparator group

Description:

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

Treatment:

Procedure: protective ileostomy group