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

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    140
  • sponsor
    Donato F Altomare
Updated on 25 March 2022
cancer surgery
chemoradiotherapy
rectal anastomosis
adenocarcinoma
anastomotic leak
permanent colostomy

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

Details
Condition Rectal Cancer
Treatment transanal anastomotic reinforcement, protective ileostomy group, a circular anal dilator (CAD)
Clinical Study IdentifierNCT02279771
SponsorDonato F Altomare
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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