Condition category
Urological and Genital Diseases
Date applied
04/01/2012
Date assigned
10/02/2012
Last edited
24/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Background and study aims
Pelvic organ prolapse is when the womb or vagina have lost normal support and drop down from the normal positions, causing women to feel a lump or heavy feeling. Gynaecologists frequently perform surgery for prolapse and this study is examining how the skin of the vagina is stitched together at the end of the operation. Our study will compare two different ways of closing the vaginal skin at the time of surgery and the effect on pain felt afterwards.

Who can participate?
Women over the age of 18 having surgery for prolapse in our hospitals are able to participate.

What does the study involve?
Participants will have their planned surgery as normal. The only thing which will be different if taking part in the study is the way in which the skin of vagina is closed at the end. The final step of any surgery is closure of the vaginal skin and this is where the way we close the skin will be different, depending on which group the participant been allocated to. One group will have the skin closed with separate stitches spaced about half a centimetre apart, and the other group will have a single, running stitch along the whole length of the surgical incision. We are interested in how much pain is experienced by participants, so at 24 hours after your surgery we will ask about your pain using a pain scale, scoring any pain felt from 0 to 10. This will be done again after 48 hours. Patients will be seen again 12 weeks after surgery to allow us to collect information on complications after surgery.

What are the possible benefits and risks of participating?
There are no short term benefits to participants directly although in the long term we expect our study will help future patients with pelvic organ prolapse because our results may show that less post-operative pain is experienced with one particular method over the other. There are no risks or disadvantages participating in this study as we are evaluating two different closure methods that are already in current surgical practice.

Where is the study run from?
The study is being run from the University of Leicester and patients having surgery in the University Hospitals of Leicester NHS Trust will be approached to take part.

When is the study starting and how long is it expected to run for?
The study will start in June 2012 and is expected to run for about 18 months

Who is funding the study?
The study is being funded by the University of Leicester and the UHL Trust

Who is the main contact?
Dr Douglas G Tincello MB ChB MD FRCOG
dgt4@le.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Douglas Tincello

ORCID ID

Contact details

Reproductive Science Section
CSMM
RKCSB
University of Leicester
Leicester Royal Infirmary
PO Box 65
Leicester
LE2 7LX
United Kingdom
+44 (0)116 252 3165
dgt4@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1

Study information

Scientific title

Prospective randomised trial evaluating vaginal closure techniques during colporrhaphy and effects on post-operative pain

Acronym

Study hypothesis

Following vaginal prolapse surgery, post-operative pain is affected by the method of vaginal skin suturing. Our hypothesis is that continuous sutures cause less pain than interrupted sutures, without any difference in other operative morbidity.

Ethics approval

Not provided at time of registration

Study design

Randomised prospective double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Uterovaginal prolapse

Intervention

Group 1: closure of the vaginal skin with interrupted polyglycolic acid sutures
Group 2: closure of the vaginal skin with continuous unlocked polyglycolic acid sutures

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Post-operative pain immediately before pack removal, and 3 hours after pack removal. All packs will be removed 24 hours after surgery. Pain will be assessed by 10 point visual analogue scale score

Secondary outcome measures

1. Incidence of re-attendance for bleeding or discharge
2. Incidence of clinically diagnosed pelvic haematoma (attendance or admission with vaginal bleeding, ± fever, ± pain, ± ultrasound detection of haemotoma if clinically indicated)
3. Sexual dysfunction at 3 month follow-up Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) for women who are sexually active
4. Prolapse stage (assesed by POPQ) of anterior and posterior compartment at 3 month follow up

Overall trial start date

01/06/2012

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient undergoing anterior and/or posterior colporrhaphy and/or perineorrhaphy with or without vaginal hysterectomy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

110

Participant exclusion criteria

Patients receiving vaginal mesh repairs for prolapse, or concomitant surgical procedures – such as mid-urethral tape, vault suspension procedures including sacrospinous ligament fixation and sacrocolpopexy, total abdominal hysterectomy

Recruitment start date

01/06/2012

Recruitment end date

30/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

c/o Dr Graham Hewitt
Research Governance Manager
College of Medicine
Biological Sciences and Psychology
Leicester
LE1 7RH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Leicester (UK)

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

24/02/2016: The trial never started.