Early closure of stoma (temporary ileostomy )in comparison to standard procedure late closure of stoma after rectal cancer Surgery
Not Applicable
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2022/12/048069
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
â??Age group 18 to70 years
â??Able to give informed consent
â??Rectal adenocarcinoma proven by biopsy
â??Undergoing primary surgical procedure as low anterior resection with stapled anastomosis with diversion loop ileostomy
â??No anastomotic leak documented at the time of randomization
Exclusion Criteria
â??Primary surgical procedure Inter sphincteric resection low coloanal hand sewn anastomosis colostomy performed as diversion
â??Patients having diversion stoma in place done for obstruction before initiating neoadjuvant treatment
â??Diversion stomas other than loop ileostomy
â??Uncontrolled comorbidites or ASA3 patients at high risk for developing complications as assessed by the multidisciplinary team
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stoma free rates at 1 year after initial surgeryTimepoint: 1 years
- Secondary Outcome Measures
Name Time Method Complication rates reported on the Clavien-Dindo scale. A complication of Grade IIIA or higher will be considered as major morbidity at 90 days after surgery. <br/ ><br>â??Completion or Compliance to adjuvant chemotherapy <br/ ><br>â??QoL EORTC QLQ C 30 assessment at 6 months and 1 year of primary surgery <br/ ><br>â??Disease-free survival DFSTimepoint: 2 years