Status:
UNKNOWN
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery
Lead Sponsor:
Donato F Altomare
Conditions:
Rectal Cancer
Eligibility:
All Genders
30-80 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT02279771
Start Date
January 1 2015
End Date
December 1 2022
Last Update
January 11 2022
Active Locations (1)
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1
Bari, Italy, 70100