NCT02318888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,808

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

13 years

First QC Date

December 12, 2014

Last Update Submit

March 30, 2020

Conditions

Surgical Adhesions

Keywords

Small bowel obstruction, Surgery, Colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hospitalisation for small bowel obstruction

    5 years

  • Overall and cancer survival

    5 years

  • Postoperative complications

    30 days

  • Postoperative complications

    30 days

Study Arms (2)

Surgery and Icodextrin

EXPERIMENTAL

Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen

Procedure: SurgeryDrug: Icodextrin

Surgery

ACTIVE COMPARATOR

No instillations during surgery

Procedure: Surgery

Interventions

SurgeryPROCEDURE
SurgerySurgery and Icodextrin
IcodextrinDRUG
Surgery and Icodextrin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer
  • Curative surgery planned
  • Informed consent
  • Age 18-85

You may not qualify if:

  • Local surgery planned
  • Generalized disease
  • Other malignancy
  • Not informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Eskilstuna Hospital

Eskilstuna, Sweden

Location

Falun Hospital

Falun, Sweden

Location

Gävle Hospital

Gävle, Sweden

Location

Jönköping Hospital

Jönköping, Sweden

Location

Karlstad Hospital

Karlstad, Sweden

Location

Lidköping Hospital

Lidköping, Sweden

Location

Luleå Hospital

Luleå, Sweden

Location

Mora Hospital

Mora, Sweden

Location

Norrrköping Hospital

Norrköping, Sweden

Location

Nyköping Hospital

Nyköping, Sweden

Location

Torsby Hospital

Torsby, Sweden

Location

University Hospital

Uppsala, Sweden

Location

Västerås Hospital

Västerås, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 15746791BACKGROUND

  • 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.

    PMID: 17383643BACKGROUND

  • 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.

    PMID: 26934850DERIVED

MeSH Terms

Conditions

Tissue AdhesionsColorectal Neoplasms

Interventions

Surgical Procedures, OperativeIcodextrin

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Officials

  • Urban Karlbom, PhD

    University Hospital, Uppsala

    PRINCIPAL INVESTIGATOR

  • Lars Påhlman, Professor

    University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 17, 2014

Study Start

December 1, 2009

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

SE(13)