A multicentre randomised controlled trial assessing the benefit of icodextrin solution on pelvic pain and quality of life in patients having surgery to adhesions
| ISRCTN | ISRCTN77645288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77645288 |
| Secondary identifying numbers | N0283122696 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Mr Jolyon Ford
Scientific
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
| Phone | +44 (0)1903 205111 |
|---|---|
| jolyon.ford@wash.nhs.uk |
Study information
| Study design | Multicentre single-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Pain |
| Intervention | 1. Icodextrin 2. Heparinised saline |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Icodextrin |
| Primary outcome measure | 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 study start date | 01/06/2002 |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 250 (125 patients in each treatment arm) |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Sussex NHS Research Consortium (UK)
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 |
Editorial Notes
07/07/2017: No publications found in PubMed, verifying study status with principal investigator.
