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 design	Single-blind randomised controlled trial
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
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

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"	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 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.