Does Icodextrin Reduce the Risk of Small Bowel Obstruction?

Uppsala University

Status: Unknown

Conditions: Surgical Adhesions

Treatments: Procedure: Surgery; Drug: Icodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT02318888

Dnr 2009/123

Details and patient eligibility

About

The study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients with colorectal cancer. Follow-up data is collected from the Swedish national colorectal cancer registry.Patients are followed for 5 years postoperatively.The study is a randomized Swedish multicenter study and planned to include 1,800 patients. A safety control is planned after 300 included patients.

Full description

Icodextrin 7.5% is used in peritoneal dialysis. In animal models and in gynecological surgery a 4% solution of Icodextrin has been tested as a possible agent of reducing adhesions by acting as a barrier between peritoneal surfaces. Some data support a reduction af adhesions (van den Tool et al., Brown et al.). However, is not known whether icodextrin reduces the need for surgery or hospitalisation for small bowel obstruction.This study aims to study these parameters as well as complications and survival.

Patients with colorectal cancer and scheduled for surgery with curative intent will be (after patients acceptance) randomized to have icodextrin 4% instilled in the abdominal cavity or not. Patients allocated to icodextrin arm will have 100 ml of icodextrin 4% instilled every 30 minutes during surgery and at end of operation further 1000 ml instilled in the abdominal cavity. Postoperative care is performed according to each hospital praxis.

Follow-up data will be collected from the Swedish National Colorectal cancer registry. Data 30 days postoperatively will be analysed for early small bowel obstruction and other early complications. The study ends 5 years postoperatively with analysis of surgery and hospitalization for small bowel obstruction as well as survival and longterm complications.

A safety analysis is planned after the first 300 randomized patients with respect to early (30 days) complications. These data will analysed blindly by external reviewers.

Randomization (1:1) will be performed at the Regional Cancer Centrum in the Uppsala-Örebro region. The study aims to randomise 1800 patients.

Enrollment: 1,808 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colorectal cancer
• Curative surgery planned
• Informed consent
• Age 18-85

Exclusion criteria

• Local surgery planned
• Generalized disease
• Other malignancy
• Not informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,808 participants in 2 patient groups

Surgery and Icodextrin

Experimental group

Description:

Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen

Treatment:

Drug: Icodextrin

Procedure: Surgery

Surgery

Active Comparator group

Description:

No instillations during surgery

Treatment:

Procedure: Surgery