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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list