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Evaluating vaginal closure techniques during colporrhaphy and effects on post-operative pain

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83130211
Enrollment
110
Registered
2012-02-10
Start date
2012-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterovaginal prolapse Urological and Genital Diseases Uterovaginal prolapse, unspecified

Interventions

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

Sponsors

University of Leicester (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026