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Surgical AdhesionsNCT02318888

Does Icodextrin Reduce the Risk of Small Bowel Obstruction?

A study testing Surgery and Icodextrin in people with Surgical Adhesions, run by Uppsala University at 13 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Surgical Adhesions
What is being tested?
Surgery and Icodextrin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,808 participants
Where
13 sitesSweden
Study dates
Dec 2009to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Sweden13 sites

  • Eskilstuna Hospital

    Eskilstuna

  • Falun Hospital

    Falun

  • Gävle Hospital

    Gävle

  • Jönköping Hospital

    Jönköping

  • Karlstad Hospital

    Karlstad

  • Lidköping Hospital

    Lidköping

  • Luleå Hospital

    Luleå

  • Mora Hospital

    Mora

  • Norrrköping Hospital

    Norrköping

  • Nyköping Hospital

    Nyköping

  • Torsby Hospital

    Torsby

  • University Hospital

    Uppsala

  • Västerås Hospital

    Västerås

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Surgery, Icodextrin
Keywords
Small bowel obstruction, Surgery, Colorectal cancer
Medical subject headings
Tissue Adhesions, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

  • IcodextrinDrug

Study groups in NCT02318888
Study groupRoleWhat they receive
Surgery and IcodextrinExperimentalIcodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
Receives: Procedure: Surgery; Drug: Icodextrin
SurgeryActive comparatorNo instillations during surgery
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgery for small bowel obstruction

    The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.

    Measured: 5 years

Secondary outcomes (4)

  1. Hospitalisation for small bowel obstruction

    Measured: 5 years

  2. Overall and cancer survival

    Measured: 5 years

  3. Postoperative complications

    Safety control of first 300 randomised patients

    Measured: 30 days

  4. Postoperative complications

    For all randomised patients

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2014 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,808 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318888
Sponsor's protocol ID
Dnr 2009/123
Status last verified
Mar 2020
First submitted
12 Dec 2014
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 15746791

  • 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.

    PubMed 17383643

  • 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.

    PubMed 26934850

Questions about this trial

What is this clinical trial studying?

A study testing Surgery and Icodextrin in people with Surgical Adhesions, run by Uppsala University at 13 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgery for small bowel obstruction (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02318888, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

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