Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
Primary Purpose
Surgical Adhesions
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Surgery
Icodextrin
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Adhesions focused on measuring Small bowel obstruction, Surgery, Colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- Colorectal cancer
- Curative surgery planned
- Informed consent
- Age 18-85
Exclusion Criteria:
- Local surgery planned
- Generalized disease
- Other malignancy
- Not informed consent
Sites / Locations
- Eskilstuna Hospital
- Falun Hospital
- Gävle Hospital
- Jönköping Hospital
- Karlstad Hospital
- Lidköping Hospital
- Luleå Hospital
- Mora Hospital
- Norrrköping Hospital
- Nyköping Hospital
- Torsby Hospital
- University Hospital
- Västerås Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgery and Icodextrin
Surgery
Arm Description
Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
No instillations during surgery
Outcomes
Primary Outcome Measures
Surgery for small bowel obstruction
The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.
Secondary Outcome Measures
Hospitalisation for small bowel obstruction
Overall and cancer survival
Postoperative complications
Safety control of first 300 randomised patients
Postoperative complications
For all randomised patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02318888
Brief Title
Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
Official Title
Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Adhesions
Keywords
Small bowel obstruction, Surgery, Colorectal cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1808 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery and Icodextrin
Arm Type
Experimental
Arm Description
Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
No instillations during surgery
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Drug
Intervention Name(s)
Icodextrin
Primary Outcome Measure Information:
Title
Surgery for small bowel obstruction
Description
The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Hospitalisation for small bowel obstruction
Time Frame
5 years
Title
Overall and cancer survival
Time Frame
5 years
Title
Postoperative complications
Description
Safety control of first 300 randomised patients
Time Frame
30 days
Title
Postoperative complications
Description
For all randomised patients
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal cancer
Curative surgery planned
Informed consent
Age 18-85
Exclusion Criteria:
Local surgery planned
Generalized disease
Other malignancy
Not informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urban Karlbom, PhD
Organizational Affiliation
University Hospital, Uppsala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Påhlman, Professor
Organizational Affiliation
University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Eskilstuna Hospital
City
Eskilstuna
Country
Sweden
Facility Name
Falun Hospital
City
Falun
Country
Sweden
Facility Name
Gävle Hospital
City
Gävle
Country
Sweden
Facility Name
Jönköping Hospital
City
Jönköping
Country
Sweden
Facility Name
Karlstad Hospital
City
Karlstad
Country
Sweden
Facility Name
Lidköping Hospital
City
Lidköping
Country
Sweden
Facility Name
Luleå Hospital
City
Luleå
Country
Sweden
Facility Name
Mora Hospital
City
Mora
Country
Sweden
Facility Name
Norrrköping Hospital
City
Norrköping
Country
Sweden
Facility Name
Nyköping Hospital
City
Nyköping
Country
Sweden
Facility Name
Torsby Hospital
City
Torsby
Country
Sweden
Facility Name
University Hospital
City
Uppsala
Country
Sweden
Facility Name
Västerås Hospital
City
Västerås
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15746791
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. doi: 10.1016/j.surg.2004.06.001.
Results Reference
background
PubMed Identifier
17383643
Citation
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.
Results Reference
background
PubMed Identifier
26934850
Citation
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.
Results Reference
derived
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Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
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