The comparing study on two different methods of creating a stoma in patients who need a permanent colostomy.

Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma – A randomized controlled trial - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059362

Enrollment

200

Registered

2023-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified

Interventions

Intervention1: circular stapled end colostomy: The circular stapler, also called the EEA (end-to-end anastomosis) stapling device, is routinely used for creating an anastomosis between two ends of the

Eligibility

Inclusion criteria

Inclusion criteria: Permanent end colostomies Can understand English/Hindi/Marathi

Exclusion criteria

Exclusion criteria: Patients undergoing loop colostomy or loop/end ileostomy Emergency operations Consent was not obtained/provided

Design outcomes

Primary

Measure	Time frame
1-year parastomal hernia (PSH) rate defined both by radiology and clinical symptoms Definition: Clinical: The identifiable bulge around the stoma site with cough impulse Bulge without cough impulse that causes difficulty with stoma appliances (improper fit, leakage, skin maceration) Radiological Morena-Matias classification for PSH (grades 1- 3) Any herniation of intra abdominal content beyond the abdominal wall or a hernia sac identified in the supine position will be defined as a parastomal hernia. A bulging bowel only at a prone position will be registered but not considered a hernia.Timepoint: 48 months	—

Measure

Time frame

1-year parastomal hernia (PSH) rate defined both by radiology and clinical symptoms Definition: Clinical: The identifiable bulge around the stoma site with cough impulse Bulge without cough impulse that causes difficulty with stoma appliances (improper fit, leakage, skin maceration) Radiological Morena-Matias classification for PSH (grades 1- 3) Any herniation of intra abdominal content beyond the abdominal wall or a hernia sac identified in the supine position will be defined as a parastomal hernia. A bulging bowel only at a prone position will be registered but not considered a hernia.Timepoint: 48 months

—

Secondary

Measure	Time frame
Any stoma-related complication at 30 days 90-day overall complication rate on the Clavien-Dindo scale9 Re-operation rate for stoma-related complications Timepoint: 48 Months	—

Countries

India

Contacts

Public ContactDr Avanish Saklani

Tata Memorial Hospital

asaklani@hotmail.com7400319886

Outcome results

None listed

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