Condition category
Urological and Genital Diseases
Date applied
21/08/2005
Date assigned
15/09/2005
Last edited
13/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sabeena Allahdin

ORCID ID

Contact details

26 Springdale Road Bieldside
Aberdeen
AB15 9FA
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Medical School
R&D Department
Foresterhill Annexe
Foresterhill Road
Aberdeen
AB25 2ZB
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18604681

Publication citations

  1. 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.

Additional files

Editorial Notes