Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes