Are you due to have a laparoscopy for symptoms suggestive of endometriosis?

Published on
Topic(s)
Clinical Trials
Diagnosis
Surgery

Are you due to have a laparoscopy for symptoms suggestive of endometriosis?

Many women with endometriosis are treated surgically but symptoms can recur in just under half of them. Clinicians are uncertain about how best to prevent this.

32 hospitals throughout the UK have joined a large national clinical trial to find out if long acting progestogen treatment (either Mirena Coil® or  Depo-Provera® ) is more effective compared to the oral contraceptive pill in preventing the recurrence of symptoms and improving quality of life.

The target population is women of reproductive age with laparoscopically diagnosed endometriosis, who have undergone conservative surgery for alleviation of pelvic pain, and who have no contraindications to any of the proposed hormonal treatments. The PRE-EMPT trial will be discussed with women when they are scheduled for laparoscopic surgery.

The treatments offered in PRE-EMPT are:

  • Mirena® coil
  • Progestogens
  • Combined oral Contraceptive

Further details of these can be found at https://www.endometriosis-uk.org/hormones

You may be eligible to take part in the PRE-EMPT trial if you

  • Are aged between 16-45 years
  • Have no immediate plans to conceive
  • Are scheduled to have laparoscopy with concurrent surgery for pelvic pain associated with endometriosis
  • Willing to be randomised  to either:

 

  •  long acting progestogen treatment (you can choose between Mirena® or Depo-provera®

or

  • The combined oral contraceptive

What the trial involves

We will collect information on your pain, physical and emotional wellbeing  at the beginning of the study.  A similar questionnaire will then be sent to you at home at 6 months, then 1, 2 and 3 years after treatment.  The questions are designed to find out if there are any improvements or changes in your symptoms following treatment

Which hospitals are taking part

Aberdeen Royal InfirmaryQMC - Nottingham Treatment Centre
Addenbrooke's (Cambridge)Royal Albert Edward Infirmary
Arrowe Park HospitalRoyal Berkshire Hospital
Basingstoke & N.HampshireRoyal Infirmary of Edinburgh
Birmingham Women's HospitalRoyal Preston Hospital
Chelsea and Westminster HospitalSouthend University Hospital
Chesterfield Royal HospitalSt Mary's, Manchester
Cumberland Infirmary & W. Cumberland HospitalSt Peter's Hospital
Furness General HospitalSt Richard's Hospital, Chichester
James Cook University HospitalStoke Mandeville Hospital
John Radcliffe HospitalThe Royal Victoria Infirmary (Newcastle)
Kings Mill HospitalUniversity College London Hospital
Liverpool Women's HospitalUniversity Hospital Crosshouse
Milton Keynes HospitalUniversity Hospital of North Durham
Peterborough City HospitalUniversity Hospital of North Tees
Princess of Wales (Wales)Yeovil District Hospital

How to get involved

For more information about the hospitals recruiting and how to get in touch with us please contact:

Laura Gennard

Senior Trial Coordinator

Tel:  +44 (0)121 415 9109

Fax:  +44 (0)121 415 9136  

Email:  d.a.m.farrell@bham.ac.uk

Web: pre-empt@trials.bham.ac.uk

Birmingham Clinical Trials Unit (BCTU)

Institute of Applied Health Research

Public Health Building

University of Birmingham

Edgbaston

Birmingham

B15 2TT