Clinical trial NCT02318888: Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
Official title: Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Adhesions
Keywords: Small bowel obstruction, Surgery, Colorectal cancer
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 1808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgery for small bowel obstruction
timeFrame: 5 years
Secondary outcomes:
measure: Hospitalisation for small bowel obstruction
timeFrame: 5 years
measure: Overall and cancer survival
timeFrame: 5 years
measure: Postoperative complications
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Eskilstuna Hospital
city: Falun
country: Sweden
facility: Falun Hospital
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Jönköping
country: Sweden
facility: Jönköping Hospital
city: Karlstad
country: Sweden
facility: Karlstad Hospital
city: Lidköping
country: Sweden
facility: Lidköping Hospital
city: Luleå
country: Sweden
facility: Luleå Hospital
city: Mora
country: Sweden
facility: Mora Hospital
city: Norrköping
country: Sweden
facility: Norrrköping Hospital
city: Nyköping
country: Sweden
facility: Nyköping Hospital
city: Torsby
country: Sweden
facility: Torsby Hospital
city: Uppsala
country: Sweden
facility: University Hospital
city: Västerås
country: Sweden
facility: Västerås Hospital
Study officials:
affiliation: University Hospital, Uppsala
name: Urban Karlbom, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital
name: Lars Påhlman, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.