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

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

Sponsor information

University of Aberdeen (UK)
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