Mesh vs anterior repair surgery for vaginal prolapse

ISRCTN ISRCTN69747860
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

Benenden Hospital Trust
Goddards Green Road
Benenden
Kent
TN17 4AX
United Kingdom

Email mhefni@benenden.org.uk

Study information

Study designSingle-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMesh vs anterior repair surgery for vaginal prolapse
Study acronymMARS
Study objectivesIf 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) studiedGenital prolapse
InterventionAnteror fascial repair vs anterior mesh repair
Intervention typeOther
Primary outcome measureAnatomical 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 measures1. 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 date01/12/2007
Completion date01/11/2010

Eligibility

Participant type(s)Patient
Age groupAll
SexFemale
Target number of participants250
Key inclusion criteria1. Women with symptomatic anterior vaginal wall prolapse needing surgery
2. Age: No age limits
Key exclusion criteria1. 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 enrolment01/12/2007
Date of final enrolment01/11/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Benenden Hospital Trust
Kent
TN17 4AX
United Kingdom

Sponsor information

Benenden Hospital Trust (UK)
Hospital/treatment centre

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

Website http://www.benenden.org.uk
ROR logo "ROR" https://ror.org/01bcp3a67

Funders

Funder type

Hospital/treatment centre

Benenden Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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