Condition category
Digestive System
Date applied
04/01/2008
Date assigned
22/02/2008
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jyrki Kössi

ORCID ID

Contact details

Department of Surgery
Päijät-Häme Central Hospital
Keskussairaalankatu 7
Lahti
15850
Finland
jyrki.kossi@phsotey.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of 4% icodextrin solution vs lactated Ringer's solution on adhesiolysis during Hartmann's reversal: A multi-centre randomised controlled trial

Acronym

Study hypothesis

Laparotomy almost always causes peritoneal adhesions, which further causes morbidity and even mortality. A regimen to prevent peritoneal adhesions is urgently needed. Icodextrin has been shown to prevent adhesion formation, and our study investigated further the efficacy of icodextrin in colorectal operation.

Study hypothesis:
4% icodextrin solution decreases adhesion formation and time needed to divide them after hartmann's procedure compared to lactated Ringer's solution.

Ethics approval

National approval of the study received on 30 April 2003 from the Ethical Committee of Päijät-Häme Hospital District ETL-code Q36. Further approved by every local ethical committee of participating hospitals.

Study design

Prospective, double-blind, multi-centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Laparotomy/ peritoneal adhesions

Intervention

The study group receives at the end of Hartmann's procedure 1000 ml of 4 % icodextrin instilled into the abdomen. The control group receives same amount of lactated Ringer's solution.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Time needed to separate postoperative adhesions, assessed approximately 3 months after hartmann's reversal procedure
2. Total operative time

Secondary outcome measures

1. Complications and recovery after Hartmann's reversal procedure. Duration of follow-up: 1 month
2. Safety of icodextrin. Duration of follow-up: 1 month

Overall trial start date

01/10/2003

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients having rectosigmoid colon obstruction, perforation or diverticulitis (with or without perforation) for which a Hartmann's operation was planned

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

1. Refusal to consent
2. Pregnancy
3. Peritoneal carcinoma
4. Postoperative radiotherapy before restorative surgery
5. Reoperation violating study protocol
6. Severe concomitant disease or other reason that would probably interfere with the restorative surgery

Recruitment start date

01/10/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Finland

Trial participating centre

Department of Surgery
Lahti
15850
Finland

Sponsor information

Organisation

Päijät-Häme Central Hospital (Finland)

Sponsor details

Keskussairaalankatu 7
Lahti
15850
Finland
jyrki.kossi@phsotey.fi

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Internally funded by the Päijät-Häme Central Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes