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
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