Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery
Overview
- Phase
- Not Applicable
- Sponsor
- Donato F Altomare
- Enrollment
- 140
- Primary Endpoint
- anastomotic leak
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
anastomotic leak
Time Frame: 30 postoperative days
anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis
Secondary Outcomes
- duration of the two operations(Intraoperative)
- Number of overall postoperative complications(30 postoperative days)
Investigators
Donato F Altomare
Associate professor
Societa Italiana di Chirurgia ColoRettale