Health Condition 1: null- Low Rectal cancer
Conditions
Interventions
Intervention1: Extralevator abdominoperineal excision: This is a modification of the standard abdominoperineal excision wherein the levator ani muscle is completely resected en bloc with the specimen
Sponsors
Ramakrishnan A S
Eligibility
Inclusion criteria
Inclusion criteria: ECOG performance status 0-2 1.Histologically confirmed adenocarcinoma lower third rectum (within 5cm from anal verge) who have received neoadjuvant long-course chemoradiation according to the institutional protocol 2.Clinically staged as cT3-T4 and/or clinically node positive by preoperative MRI 3.Requiring abdominoperineal excision with a curative intent as indicated by a.Absence of malignant ascites or peritoneal dissemination except if confined to pelvic peritoneum and which can be resected completely b.Limited metastatic disease in the liver or lung which are amenable to surgical resection and are treated with a curative intent c.Local disease amenable for R0 resection, denoted by absence of pelvic side wall involvement on imaging. Disease involving the prostate or posterior vaginal wall will be eligible if R0 resection can be achieved by a sleeve resection of the prostate or posterior vaginal wall en-bloc.
Exclusion criteria
Exclusion criteria: X Pregnancy X Acute myocardial infarction within the past 6 months. Patients who are status post-revascularization procedures with satisfactory cardiac function are eligible X Significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or severe pulmonary disease) that would preclude general anaesthesia and a major abdominal operation X History of psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rates of positive CRM, intra-operative perforation, specimen gradings and amount of tissue removed around the rectum in patients with low rectal cancer undergoing ELAPE as compared to standard APETimepoint: completion of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the intra-operative complications, blood loss, operative time and perineal wound complications between the two groups. 2. To compare the urinary and sexual function after surgery between the two groups Timepoint: 1 month and 3 months | — |
Countries
India
Contacts
Public ContactRamakrishnan A S
Cancer Institute(WIA)
Outcome results
None listed