Status:
NOT_YET_RECRUITING
Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE
Lead Sponsor:
Kuban State Medical University
Collaborating Sponsors:
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
City Clinical Oncology Hospital No 1
Conditions:
Rectum Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A multicenter, cohort, randomized, controlled study is being conducted since the 1of September, 2023 whereby the immediate and long-term results of pelvic floor and perineal wound plastic surgery afte...
Detailed Description
The aim of the study is to improve the results of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation (EAPE) of the rectum for cancer of the lower ampull...
Eligibility Criteria
Inclusion
- Patients over 18 years old suffering from cancer of the lower ampullary rectum cT1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition).
- Patients with planned extralevatory abdominal-perineal extirpation of the rectum.
- Physical status of patients according to ASA classification I-II.
- Signed informed consent to participate in the study.
- Non-inclusion criteria:
- Verification of the squamous cell carcinoma diagnosis.
- The presence of acute purulent processes in the area of surgical intervention.
Exclusion
- Refusal to participate at any stage of the study.
- Death in the early postoperative period (up to 30 days after surgery) caused by somatic complications not associated with surgery (PATE, myocardial infarction, stroke).
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06066931
Start Date
October 1 2023
End Date
October 1 2026
Last Update
October 10 2023
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