Adhesion prevention with icodextrin

ISRCTN	ISRCTN76047793
DOI	https://doi.org/10.1186/ISRCTN76047793
Secondary identifying numbers	N/A

Submission date: 04/01/2008
Registration date: 22/02/2008
Last edited: 22/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jyrki Kössi
Scientific

Department of Surgery
Päijät-Häme Central Hospital
Keskussairaalankatu 7
Lahti
15850
Finland

Email	jyrki.kossi@phsotey.fi

Study information

Study design	Prospective, double-blind, multi-centre, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2003
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	40
Key inclusion criteria	All patients having rectosigmoid colon obstruction, perforation or diverticulitis (with or without perforation) for which a Hartmann's operation was planned
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Finland

Study participating centre

Department of Surgery

Lahti
15850
Finland

Sponsor information

Päijät-Häme Central Hospital (Finland)
Not defined

Keskussairaalankatu 7
Lahti
15850
Finland

Email	jyrki.kossi@phsotey.fi
"ROR"	https://ror.org/02v92t976

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan