Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
NCT ID: NCT02318888
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1808 participants
INTERVENTIONAL
2009-12-31
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Surgery and Icodextrin
Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
Surgery
Icodextrin
Surgery
No instillations during surgery
Surgery
Interventions
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Surgery
Icodextrin
Eligibility Criteria
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Inclusion Criteria
* Curative surgery planned
* Informed consent
* Age 18-85
Exclusion Criteria
* Generalized disease
* Other malignancy
* Not informed consent
18 Years
85 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Urban Karlbom, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Uppsala
Lars Påhlman, Professor
Role: STUDY_DIRECTOR
University Hospital
Locations
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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, , Sweden
Countries
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References
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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.
Other Identifiers
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Dnr 2009/123
Identifier Type: -
Identifier Source: org_study_id
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