Ten Versus Fifteen Centimeter Pouch in IPAA Surgery (TESTIMONY)

Odense University Hospital

Status: Enrolling

Conditions: Familial Adenomatous Polyposis; Ulcerative Colitis

Treatments: Procedure: 15 cm pouch; Procedure: 10 cm pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT06538402

OP_2227

Details and patient eligibility

About

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.

Full description

The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.

Secondary aims include health-related quality of life measures and postoperative complications.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
• Signed informed consent
• Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

10 cm

Experimental group

Description:

Ileal reservoir length of 10 cm

Treatment:

Procedure: 10 cm pouch

15 cm

Active Comparator group

Description:

Ileal reservoir length of 15 cm

Treatment:

Procedure: 15 cm pouch