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Early versus regular closure of Temporary Ileostomy(small bowel) done in colorectal surgeries - a prospective study

Early versus Conventional closure of Temporary Ileostomy - A Prospective Randomised Controlled Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017016
Enrollment
80
Registered
2019-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C19- Malignant neoplasm of rectosigmoidjunction Health Condition 2: C20- Malignant neoplasm of rectum

Interventions

Intervention1: early ileostomy closure: Ileostomy closure will be done within 8-12 days following index operation. Control Intervention1: Conventional ileostomy closure: Closure of the temporary ileos

Sponsors

Amrita institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients undergoing temporary stoma following colorectal surgeries from january 2019 to December 2019.

Exclusion criteria

Exclusion criteria: 1.Emergency stoma revisions 2.Signs of sepsis or organ failure in postoperative period (index surgery) 3.Radiological signs of anastomotic leak(POD 6 to 8 CT abdomen with rectal contrast) 4.Age 85yrs old 5.Coloanal anastomosis

Design outcomes

Primary

MeasureTime frame
Postoperative complicationsTimepoint: Post operative complications within 30 days documented as per clavien dindo classification First follow up 1month after stoma closure second follow up 3 months after stoma closure quality of life assessment using standard questionnaire before stoma closure and during subsequent follow ups.

Secondary

MeasureTime frame
Mortality Health related quality of life Cost analysis Timepoint: Patients will be called for 1st follow up at 4 weeks and 2nd follow up at third month after surgery and will be assessed for frequency of complications, quality of life as assessed by modified health questionnaire of European organization of research and treatment of cancer.

Countries

India

Contacts

Public ContactJayapala Reddy velagala

Amrita institute of medical sciences

sudheerov@aims.amrita.edu9447129111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026