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 |
| Protocol serial number | N0283122696 |
| Sponsor | Department of Health (UK) |
| Funder | Sussex NHS Research Consortium (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre single-blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Icodextrin |
| Primary outcome measure(s) |
Chronic pain measured before and 18 weeks after surgery on a visual analogue scale |
| Key secondary outcome measure(s) |
1. Separate questions for dysmenorrhoea (pain with periods), dyspareunia (pain on intercourse), and dyschezia (pain on defecation) |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 250 |
| 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
- United Kingdom
- England
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
