Status:
COMPLETED
TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.
Lead Sponsor:
Osama Mohammad Ali ElDamshety
Collaborating Sponsors:
Mansoura University
Marche Polytechnic university, Ancona, Italy
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The two surgical options for lower 1/3 rectal cancer is APR and sphincter sparing procedures. Intersphincteric resection is procedure to treat very low rectal cancer within 2 cm from the dentate line ...
Detailed Description
During the period between April 2013 and July 2019, a non-randomized controlled study was performed at two tertiary centers; Oncology Centre of Mansoura University and Policlinico Umberto Primo surger...
Eligibility Criteria
Inclusion
- Patients with low rectal carcinoma(The lowest margin of tumor located 3 cm from anal verge ; ≤ 2 cm from dentate lines; 1 cm from anorectal rings.
- Local spread restricted to the rectal wall or the internal anal sphincter.
- Adequate preoperative sphincter function and continence.
- Absence of distant metastasis.
Exclusion
- Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4.
- Metastatic rectal cancer.
- Those in Dukes stage D (T4 lesion).
- Undifferentiated tumours.
- Local infiltration of external anal sphincter or levator ani muscles.
- Tumor located more than 2 cm above the dentate line.
- Presence of fecal incontinence.
- Patients unwilling to take part in the study.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01836926
Start Date
April 1 2013
End Date
July 1 2019
Last Update
May 5 2020
Active Locations (2)
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1
Mansoura oncology centre
Al Mansurah, Dakahlia Governorate, Egypt
2
Mansoura university oncology centre
Al Mansurah, Dakahlia Governorate, Egypt