Stoma formation using the sutured trephine annular reinforcement technique

A randomised controlled trial of Sutured Trephine Annular Reinforcement versus standard Technique to assess effect on parastomal herniation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76715050

Enrollment

100

Registered

2013-01-15

Start date

2012-09-01

Completion date

Unknown

Last updated

2020-07-06

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

Conditions

Parastomal hernias/stoma formation/colorectal surgery Surgery Colorectal surgery

Interventions

Stoma formation via standard trephine formation Stoma formation via sutured trephine annular reinforment technique

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must: 1. Require an elective stoma due to bowel disease 2. Have given written informed consent 3. Be aged 18 or over 4. Agree to the randomised procedure 5. If of childbearing potential, must have given a negative pregnancy test

Exclusion criteria

Exclusion criteria: Patients must not: 1. Be taking part in another clinical trial which directly correlates to this one 2. Have abdominal wall sepsis 3. Be pregnant 4. Be unable to consent to participation 5. Be undergiong refashioning (but not transposition) of the stoma

Design outcomes

Primary

Measure	Time frame
Parastomal hernia rates at 30 months, or at time of stoma reversal	—

Secondary

Measure	Time frame
1. Stoma related complications requiring hospital admission 2. Changes in quality of life assessments over a 30 month period	—

Countries

United Kingdom

Outcome results

None listed

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