Feasibility study for a randomised controlled trial evaluating the use of absorbable mesh, polydioxanone and polyglactin sutures for anterior and posterior vaginal wall prolapse repairs
| ISRCTN | ISRCTN86144697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86144697 |
| Secondary identifying numbers | Version 1 09 11 2004 |
- Submission date
- 21/08/2005
- Registration date
- 15/09/2005
- Last edited
- 13/10/2009
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sabeena Allahdin
Scientific
Scientific
26 Springdale Road Bieldside
Aberdeen
AB15 9FA
United Kingdom
Study information
| Study design | Randomised controlled 2x2 factorial design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | IMPRESS: Is it Mesh or Suture for PRolapsE Surgery Success |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/05/2005 |
| Completion date | 31/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 70 |
| Key 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. |
| Key exclusion criteria | Women with less than a grade 2 prolapse, those unwilling or unable to participate in the trial. |
| Date of first enrolment | 15/05/2005 |
| Date of final enrolment | 31/08/2005 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
26 Springdale Road Bieldside
Aberdeen
AB15 9FA
United Kingdom
AB15 9FA
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
Medical School
R&D Department
Foresterhill Annexe
Foresterhill Road
Aberdeen
AB25 2ZB
Scotland
United Kingdom
"ROR" |
https://ror.org/016476m91 |
|---|
Funders
Funder type
Hospital/treatment centre
Small departmental research fund
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
