Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1 09 11 2004
Study information
Scientific title
Acronym
IMPRESS: Is it Mesh or Suture for PRolapsE Surgery Success
Study hypothesis
The use of absorbable mesh or not for primary prolapse surgery.
The choice of absorbable suture for primary prolapse surgery.
What will the work achieve?
We aim to answer the following questions:
1. Is absorbable mesh (polyglactin) effective in treatment of primary prolapse surgery?
2. Is polydioxanone (PDS) or polyglactin (Vicryl) a better suture material to use for primary prolapse surgery?
3. What are the effects of mesh and different suture material on short-term and long-term morbidity, recurrence of prolapse symptoms, and quality of life?
4. Is it feasible to mount a randomised controlled trial to answer these questions?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled 2x2 factorial design trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Prolapse
Intervention
A randomised controlled trial using a 2x2 factorial design of absorbable mesh compared with no mesh, and two types of sutures for anterior or posterior pelvic organ prolapse repair.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Recurrence of (or failure to cure) prolapse symptoms. One of the aims of the feasibility study is to test how best to assess these outcome measures and their inclusiveness.
Secondary outcome measures
1. Immediate and late postoperative morbidity
2. Recurrence of prolapse
3. Quality of life
4. Satisfaction with surgery and economic outcomes
Overall trial start date
15/05/2005
Overall trial end date
31/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All women admitted for primary pelvic organ prolapse surgery with grade 2 or more pelvic organ prolapse who are willing to participate in the trial. Women undergoing concurrent hysterectomy or continence procedures will also be eligible.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant exclusion criteria
Women with less than a grade 2 prolapse, those unwilling or unable to participate in the trial.
Recruitment start date
15/05/2005
Recruitment end date
31/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
26 Springdale Road Bieldside
Aberdeen
AB15 9FA
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Small departmental research fund
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18604681
Publication citations
-
Results
Allahdin S, Glazener C, Bain C, A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery., J Obstet Gynaecol, 2008, 28, 4, 427-431, doi: 10.1080/01443610802150077.