Contact information
Type
Scientific
Primary contact
Mr Jolyon Ford
ORCID ID
Contact details
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
+44 (0)1903 205111
jolyon.ford@wash.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0283122696
Study information
Scientific title
A multicentre randomised controlled trial assessing the benefit of icodextrin solution on pelvic pain and quality of life in patients having surgery to adhesions
Acronym
Study hypothesis
We hypothesise that the infusion of 1000 ml 4% icodextrin solution into the abdomen at the end of adhesiolysis for abdomino-pelvic adhesions will result in improvements in chronic pain scores and quality of life that is superior to heparinised normal saline.
Ethics approval
Not provided at time of registration
Study design
Multicentre single-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Respiratory: Pain
Intervention
1. Icodextrin
2. Heparinised saline
Intervention type
Drug
Phase
Not Applicable
Drug names
Icodextrin
Primary outcome measures
Chronic pain measured before and 18 weeks after surgery on a visual analogue scale
Secondary outcome measures
1. Separate questions for dysmenorrhoea (pain with periods), dyspareunia (pain on intercourse), and dyschezia (pain on defecation)
2. Quality of life will be measured with an EQ-5D questionnaire (EuroQol) before and 18 weeks after the procedure
Overall trial start date
01/06/2002
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
250 (125 patients in each treatment arm)
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
01/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sussex NHS Research Consortium (UK)
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