An experiment on comparison of routine surgical closure of ostomy after eight weeks with earlier ostomy closure between two to four weeks

EARLY VERSUS CONVENTIONAL STOMA CLOSURE FOLLOWING BOWEL SURGERY- A RANDOMISED CONTROLLED TRIAL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/12/006404

Enrollment

110

Registered

2015-12-02

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: null- PATIENTS WITH TEMPORARY STOMA WHO HAD UNDERGONE BOWEL SURGERY.

Interventions

Intervention1: EARLY STOMA CLOSURE: STOMA CLOSURE DONE WITHIN 28 DAYS FOLLOWING INDEX OPERATION. Control Intervention1: CONVENTIONAL STOMA CLOSURE: STOMA CLOSURE DONE RANGED FROM 8-12 WEEKS FOLLOWING

Eligibility

Inclusion criteria

Inclusion criteria: ALL CONSECUTIVE PATIENTS UNDERGOING TEMPORARY STOMA FOLLOWING BOWEL SURGERIES.

Exclusion criteria

Exclusion criteria: 1.EMERGENCY STOMA REVISION 2. LAPAROSCOPIC BOWEL SURGERIES 3. SIGNS OF ACTIVE INFECTION OR ORGAN FAILURE IN POSTOPERATIVE PERIOD. 4. RADIOLOGICAL SIGNS OF ANASTOMOTIC LEAKAGE EVIDENT AT WATER SOLUBLE CONTRAST EXAMINATION BEFORE STOMA CLOSURE. 5.MALNOURISHED PATIENTS.

Design outcomes

Primary

Measure	Time frame
TO DETERMINE THE FREQUENCY OF COMPLICATIONS IN THE EARLY AND CONVENTIONAL STOMA CLOSURE GROUP FOLLOWING BOWEL SURGERY.Timepoint: INTRAOPERATIVE AND POSTOPERATIVE PERIOD,4 WEEKS AND 12 WEEKS AFTER STOMA CLOSURE.	—

Secondary

Measure	Time frame
TO ASSESS THE HEALTH RELATED QUALITY OF LIFE AND ANALYSE THE COST TOWARDS STOMA CARETimepoint: BEFORE AND AFTER STOMA CLOSURE	—

Countries

India

Contacts

Public ContactDr VIKRAM KATE

JIPMER

drvikramkate@gmail.com09843058013

Outcome results

None listed

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