Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery (LessStoReS)
Rectal Cancer
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring colorectal anastomosis, anastomotic leak, ileostomy, complications
Eligibility Criteria
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
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
transanal anastomotic reinforcement
protective ileostomy group
Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)
Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)