Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vaginal Vault Prolapse, Uterine Prolapse, Cystocele, Midline, Rectocele; Female. Basic parameters: 18 years — 79 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.
Detailed description
The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
All surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. Patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. The pectopexy procedure utilizes a 3x15 cm Dynamesh PRP PVDF mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.
Primary outcome measures
- Patient-reported postoperative sensation of bulging at 12 months postoperatively [Time frame: From the enrollment til follow-up visit at 12 months postoperatively]
Secondary outcome measures (12)
- Change in Pelvic Floor Organ function (PFDI-20 score) [Time frame: From enrollment til the follow-up visit 12 months postoperatively]
- Change in sexual function and urinary incontinence (PISQ-12 score). [Time frame: From the enrollment til follow-up visit at 12 months postoperatively]
- Change in quality of life. (15D questionnaire score) [Time frame: From the enrollment til follow-up visit at 12 months postoperatively]
- Change in pelvic pain (VAS score) [Time frame: From the enrollment til follow-up visit at 12 months postoperatively]
- Post voiding residual in ml. [Time frame: From enrollment til the follow-up visit 12 months postoperatively]
- Duration of surgery in minutes [Time frame: From the beginning of surgery til the end of surgery]
- Estimated blood loss in ml [Time frame: From the beginning of surgery til the end of surgery.]
- Surgical Complications according to Clavien-Dindo classification. [Time frame: From the beginning of surgery til 30 days postoperatively]
- Hospitalisation duration in days [Time frame: From the hospitalisation for surgery til discharge home.]
- Anatomical correction of prolapse according POP-Q classification [Time frame: Right before the operaton til follow-up visit at 12 months postoperatively]
- Global impression of improvement. (PGI-I questionnaire) [Time frame: At follow-up visit 12 months postoperatively]
- Re-operation rate due to recurrence of vaginal apical prolapse, cystocele or rectocele. [Time frame: From the end of surgery til follow-up visit at 12 months postoperatively]
Eligibility criteria
Inclusion criteria
- Symptomatic pelvic organ prolapse
- Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
- If uterus in situ, consent for supracervical hysterectomy
- Suitable for laparoscopic mesh surgery
- Age: 18-79 years
- Non-pregnant, no pregnancy desire.
- Sufficient Finnish language skills
- Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl >8 cm and Aa, Ba, Ap, Bp ≥0
Exclusion criteria
- Unwillingness to undergo surgery or mesh implantation
- High anesthetic or surgical risk due to comorbidities
- Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
- Desire to preserve the uterus
- Pregnancy or planning future pregnancy
- Inability to understand Finnish or study-related forms due to cognitive impairments
- Need for concomitant urinary incontinence surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- The Wellbeing Services County of South Ostrobothnia — Seinäjoki
Identifiers
NCT: NCT06902909 · R23076