Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Odense University Hospital

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: loop ileostomi

Study type: Interventional

Funder types: Other

Identifiers

NCT01865071

S-20110026

Details and patient eligibility

About

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

Full description

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.

Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.

Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.

A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.

If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.

Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.

Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.

LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All patients aged 18 years or older.
• All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
• Written informed consent was obtained from all patients

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

loop ileostomi

Experimental group

Description:

Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer

Treatment:

Procedure: loop ileostomi