Mesh vs anterior repair surgery for vaginal prolapse
ISRCTN | ISRCTN69747860 |
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DOI | https://doi.org/10.1186/ISRCTN69747860 |
Secondary identifying numbers | Project 032 |
- Submission date
- 29/04/2008
- Registration date
- 24/06/2008
- Last edited
- 13/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Mohamed Hefni
Scientific
Scientific
Benenden Hospital Trust
Goddards Green Road
Benenden
Kent
TN17 4AX
United Kingdom
mhefni@benenden.org.uk |
Study information
Study design | Single-blind randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Mesh vs anterior repair surgery for vaginal prolapse |
Study acronym | MARS |
Study objectives | 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(s) | South East Research Ethics Committee, ref: 07/H1102/95 |
Health condition(s) or problem(s) studied | Genital prolapse |
Intervention | Anteror fascial repair vs anterior mesh repair |
Intervention type | Other |
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 study start date | 01/12/2007 |
Completion date | 01/11/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | All |
Sex | Female |
Target number of participants | 250 |
Key inclusion criteria | 1. Women with symptomatic anterior vaginal wall prolapse needing surgery 2. Age: No age limits |
Key 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 |
Date of first enrolment | 01/12/2007 |
Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Benenden Hospital Trust
Kent
TN17 4AX
United Kingdom
TN17 4AX
United Kingdom
Sponsor information
Benenden Hospital Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Ken Hesketh
Goddard's Green Road
Benenden
Kent
TN17 4 AX
United Kingdom
Website | http://www.benenden.org.uk |
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https://ror.org/01bcp3a67 |
Funders
Funder type
Hospital/treatment centre
Benenden Hospital (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
13/06/2016: No publications found, verifying study status with principal investigator.