ESPriT2

Information for Recruiting Centres

An expanded trial summary and information for recruiting centres

Trial Summary:

ESPriT2 is a major UK NIHR/HTA-funded randomised controlled trial to determine if removal of superficial peritoneal endometriosis (SPE) is effective in the treatment of chronic pelvic pain.  We aim to randomise 400 women who have been SPE alone identified at diagnostic laparoscopy within 70 NHS hospitals across the UK.

At laparoscopy, participants will be randomised to either having their endometriosis removed by ablation/excision/or a combination of both (surgeon’s decision) or to diagnostic laparoscopy only.

All participants will be informed of the findings at laparoscopy but they will not be told if the endometriosis was removed or not. 

Participants will be asked to complete pain and quality of life questionnaires before their operation and then at 3, 6 and 12 months post laparoscopy.  Data on pain, quality of life, further surgical treatment and fertility outcomes will also be captured at 2 and 5 years by repeat questionnaires and data linkage.

Following laparoscopy, if participants will be allowed to take standard analgesics and hormonal therapies to manage their pain if required.

The primary outcome of ESPriT2 is the pain domain component of the Endometriosis Health Profile-30 (EHP-30) at 12 months.  Our secondary outcomes include quality of life, use of hormones and analgesics, health economics, post-op pain and reproductive outcomes.

Professor Andrew Horne and Dr Lucy Whitaker from the University of Edinburgh are the Chief Investigators, which is being managed by Professor Horne’s Trial Management Team at the University of Edinburgh with statistical and data support provided by Edinburgh Clinical Trials Unit.

 

Feasibility Questionnaire:

If your site is interested in recruiting to ESPriT2 please complete this feasibility questionnaire: https://crh-redcap.igmm.ed.ac.uk/surveys/?s=3NMKDHNHTM

 

ESPriT2 Registry Details:

Funding: NIHR HTA Programme

Sponsor: the University of Edinburgh and NHS Lothian

CPMS ID: TBC

ISCTRN: TBC

Database: REDCap