Condition category
Urological and Genital Diseases
Date applied
29/04/2008
Date assigned
24/06/2008
Last edited
13/06/2016
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 Mohamed Hefni

ORCID ID

Contact details

Benenden Hospital Trust
Goddards Green Road
Benenden
Kent
TN17 4AX
United Kingdom
-
mhefni@benenden.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project 032

Study information

Scientific title

Mesh vs anterior repair surgery for vaginal prolapse

Acronym

MARS

Study hypothesis

If there is 15% statistical difference between the 2 techniques, we shall be able to tell the gynaecological community as to which one is better. There is a lack of good quality evidence to assess the two surgical techniques. Most of the data are from retrospective studies. A well designed randomised control study is desperately needed.

Ethics approval

South East Research Ethics Committee, ref: 07/H1102/95

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Genital prolapse

Intervention

Anteror fascial repair vs anterior mesh repair

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Anatomical recurrence rate assessed using the Pelvic Organ Prolapse Quantification (POPQ) scores, assessed immediately after surgery and then 6 weeks, 6 months, 1 and 2 years post-operation.

Secondary outcome measures

1. Operating time
2. Blood loss
3. Peri-operative complications
4. Hospital stay
5. Time to recovery to normal life
6. Long-term complications (including mesh erosion). Duration of follow-up: 24 months
7. Bladder and sexual function at 6, 12 and 24 months
8. Quality of life, assessed using the EuroQol questionnaire and the Sheffield Prolapse Symptoms Questionnaire at 6, 12 and 24 months
9. Patient satisfaction, assessed at 6, 12 and 24 months
10. Pain score, assessed daily up to 7 days post-operation

Overall trial start date

01/12/2007

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with symptomatic anterior vaginal wall prolapse needing surgery
2. Age: No age limits

Participant type

Patient

Age group

All

Gender

Female

Target number of participants

250

Participant exclusion criteria

1. Contraindication to mesh repair surgery: unstable diabetes, long term high dose steroids, prosthetic heart valve, marked immunosuppression
2. Connective tissue disorders (Ehler-Danlos or Marfan's)
3. Inability to give informed consent

Recruitment start date

01/12/2007

Recruitment end date

01/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Benenden Hospital Trust
Kent
TN17 4AX
United Kingdom

Sponsor information

Organisation

Benenden Hospital Trust (UK)

Sponsor details

c/o Ken Hesketh
Goddard's Green Road
Benenden
Kent
TN17 4 AX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.benenden.org.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Benenden Hospital (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

13/06/2016: No publications found, verifying study status with principal investigator.