Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Vaginal Vault Prolapse Uterine Prolapse Cystocele, Midline Rectocele; Female

Keywords

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laparoscopic pectopexy laparoscopic colporraphy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic pectopexy with or without concomitant laparoscopic colporraphy

Patients undergoing laparoscopic pectopexy for pelvic organ prolapse, with or without concomitant laparoscopic anterior and posterior vaginal wall repair using sutures. The procedure involves the placement of a 3x15 cm Dynamesh PRP PVDF mesh to the vaginal apex or uterine cervical stump with monofilament and multifilament sutures and anchored to the pectineal ligaments bilaterally. Follow-up assessments will be conducted 12 months postoperatively to evaluate symptom relief, anatomical correction, and surgical safety.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsi Kuismanen, MD, PhD

Role: STUDY_CHAIR

Tampere University

Kari Nieminen, MD, PhD

Role: STUDY_CHAIR

Tampere University

Locations

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The Wellbeing Services County of South Ostrobothnia

Seinäjoki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R23076

Identifier Type: -

Identifier Source: org_study_id