Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Eskilstuna, Sweden
- Eskilstuna Hospital
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Falun, Sweden
- Falun Hospital
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Gävle, Sweden
- Gävle Hospital
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Jönköping, Sweden
- Jönköping Hospital
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Karlstad, Sweden
- Karlstad Hospital
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Lidköping, Sweden
- Lidköping Hospital
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Luleå, Sweden
- Luleå Hospital
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Mora, Sweden
- Mora Hospital
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Norrköping, Sweden
- Norrrköping Hospital
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Nyköping, Sweden
- Nyköping Hospital
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Torsby, Sweden
- Torsby Hospital
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Uppsala, Sweden
- University Hospital
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Västerås, Sweden
- Västerås Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Surgery and Icodextrin
Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
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|
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Active Comparator: Surgery
No instillations during surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgery for small bowel obstruction
Time Frame: 5 years
|
The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalisation for small bowel obstruction
Time Frame: 5 years
|
5 years
|
|
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Overall and cancer survival
Time Frame: 5 years
|
5 years
|
|
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Postoperative complications
Time Frame: 30 days
|
Safety control of first 300 randomised patients
|
30 days
|
|
Postoperative complications
Time Frame: 30 days
|
For all randomised patients
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Urban Karlbom, PhD, University Hospital, Uppsala
- Study Director: Lars Påhlman, Professor, University Hospital
Publications and helpful links
General Publications
- 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. doi: 10.1016/j.surg.2004.06.001.
- 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. doi: 10.1016/j.fertnstert.2006.12.084. Epub 2007 Mar 26.
- Sakari T, Sjodahl R, Pahlman L, Karlbom U. Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial. Colorectal Dis. 2016 Mar;18(3):295-300. doi: 10.1111/codi.13095. Erratum In: Colorectal Dis. 2016 Apr;18(4):427.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2009/123
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