Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

Sponsor
Odense University Hospital
Study ID
NCT06538402
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 10 cm pouch — PROCEDURE
    A 10 cm pouch will be constructed
  • 15 cm pouch — PROCEDURE
    A 15 cm pouch will be constructed

Study Details

The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.

Key Dates

First listed
Aug 5, 2024
Start date
Jul 3, 2025
Status verified
Jul 2025
Primary completion
Jul 3, 2028
Completion
Jul 3, 2038

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 10 cm
    Ileal reservoir length of 10 cm
  • Active Comparator: 15 cm
    Ileal reservoir length of 15 cm

Primary Outcome Measure

Pouch dysfunction score [ Time Frame: 1, 3, 5 and 10 years after surgery ]

Central Contacts

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