Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Early stoma closure: Arm A Early stoma closure between day 7 â?? day 28 of primary surgery
Control Intervention1: delayed stoma closure: Arm B Standard delayed stoma closure- according
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stoma free rates at 1 year after initial surgeryTimepoint: 1 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. â??Completion or Compliance to adjuvant chemotherapy â??QoL EORTC QLQ C 30 assessment at 6 months and 1 year of primary surgery â??Disease-free survival DFSTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Avanish Saklani
Tata Memorial Hospital
Outcome results
None listed