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ISRCTN
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ISRCTN76047793
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ClinicalTrials.gov identifier
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Public title
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Adhesion prevention with icodextrin
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Scientific title
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The effect of 4% icodextrin solution vs lactated Ringer's solution on adhesiolysis during Hartmann's reversal: A multi-centre randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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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.
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Study design
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Prospective, double-blind, multi-centre, randomised controlled trial
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Countries of recruitment
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Finland
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Disease/condition/study domain
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Laparotomy/ peritoneal adhesions
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Participants - inclusion criteria
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All patients having rectosigmoid colon obstruction, perforation or diverticulitis (with or without perforation) for which a Hartmann's operation was planned
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2003
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Anticipated end date
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31/12/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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1. Time needed to separate postoperative adhesions, assessed approximately 3 months after hartmann's reversal procedure
2. Total operative time
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Secondary outcome measure(s)
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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
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Sources of funding
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Internally funded by the Päijät-Häme Central Hospital (Finland)
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Trial website
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Publications
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Contact name
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Dr
Jyrki
Kössi
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Address
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Department of Surgery
Päijät-Häme Central Hospital
Keskussairaalankatu 7
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City/town
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Lahti
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Zip/Postcode
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15850
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Country
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Finland
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Email
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jyrki.kossi@phsotey.fi
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Sponsor
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Päijät-Häme Central Hospital (Finland)
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Address
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Keskussairaalankatu 7
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City/town
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Lahti
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Zip/Postcode
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15850
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Country
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Finland
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Email
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jyrki.kossi@phsotey.fi
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Date applied
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04/01/2008
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Last edited
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22/02/2008
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Date ISRCTN assigned
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22/02/2008
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