Does Icodextrin Reduce the Risk of Small Bowel Obstruction?

Surgical Adhesions Clinical Trial

Official title:

Does Icodextrin Reduce the Risk of Small Bowel Obstruction?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02318888
• Other study ID #: Dnr 2009/123
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2009
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1808
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Colorectal cancer

• Curative surgery planned

• Informed consent

• Age 18-85

Exclusion Criteria:

• Local surgery planned

• Generalized disease

• Other malignancy

• Not informed consent

Related Conditions & MeSH terms

• Intestinal Obstruction
• Surgical Adhesions
• Tissue Adhesions

Intervention

Procedure:
• Surgery

Drug:
• Icodextrin

Locations

Country	Name	City	State
Sweden	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	Torsby Hospital	Torsby
Sweden	University Hospital	Uppsala
Sweden	Västerås Hospital	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Brown CB, Luciano AA, Martin D, Peers E, Scrimgeour A, diZerega GS; Adept Adhesion Reduction Study Group. Adept (icodextrin 4% solution) reduces adhesions after laparoscopic surgery for adhesiolysis: a double-blind, randomized, controlled study. Fertil Steril. 2007 Nov;88(5):1413-26. Epub 2007 Mar 26. — View Citation

van den Tol P, ten Raa S, van Grevenstein H, Marquet R, van Eijck C, Jeekel H. Icodextrin reduces postoperative adhesion formation in rats without affecting peritoneal metastasis. Surgery. 2005 Mar;137(3):348-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery for small bowel obstruction	The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.	5 years
Secondary	Hospitalisation for small bowel obstruction		5 years
Secondary	Overall and cancer survival		5 years
Secondary	Postoperative complications	Safety control of first 300 randomised patients	30 days
Secondary	Postoperative complications	For all randomised patients	30 days