Does Icodextrin Reduce the Risk of Small Bowel Obstruction?

Not Applicable

• Conditions: Surgical Adhesions
• Interventions: Procedure: Surgery; Drug: Icodextrin

• Registration Number: NCT02318888
• Lead Sponsor: Uppsala University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1808

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	No instillations during surgery
Surgery and Icodextrin	Surgery	Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
Surgery and Icodextrin	Icodextrin	Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen

Primary Outcome Measures

Name	Time	Method
Surgery for small bowel obstruction	5 years	The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days	For all randomised patients
Hospitalisation for small bowel obstruction	5 years
Overall and cancer survival	5 years

Trial Locations

Locations (13)

Eskilstuna Hospital; 🇸🇪 Eskilstuna, Sweden

Falun Hospital; 🇸🇪 Falun, Sweden

Gävle Hospital; 🇸🇪 Gävle, Sweden

Jönköping Hospital; 🇸🇪 Jönköping, Sweden

Karlstad Hospital; 🇸🇪 Karlstad, Sweden

Lidköping Hospital; 🇸🇪 Lidköping, Sweden

Luleå Hospital; 🇸🇪 Luleå, Sweden

Mora Hospital; 🇸🇪 Mora, Sweden

Norrrköping Hospital; 🇸🇪 Norrköping, Sweden

Nyköping Hospital; 🇸🇪 Nyköping, Sweden

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