Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05143658
Collaborator
(none)
40
1
2
35.5
1.1

Study Details

Study Description

Brief Summary

The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.

Condition or Disease Intervention/Treatment Phase
  • Procedure: LLS versus LP
N/A

Detailed Description

Primary and secondary endpoints:

Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.

Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.

The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.

Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Actual Study Start Date :
Dec 6, 2021
Actual Primary Completion Date :
Dec 6, 2021
Anticipated Study Completion Date :
Nov 22, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Laparoscopic Lateral Suspension Group (LLS)

Anterior and apical prolapse repair via LLS

Procedure: LLS versus LP
Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy

Experimental: Laparoscopic Pectopexy (LP)

Anterior and apical prolapse repair via LP

Procedure: LLS versus LP
Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy

Outcome Measures

Primary Outcome Measures

  1. Subjective cure rate of prolapse [[ Time Frame: 12 months after intervention ]]

    Provided by the patient's feeling of the "Absence of a bulge in the vagina"

  2. Objective success [[ Time Frame: 12 months after intervention ]]

    Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total

Secondary Outcome Measures

  1. Prolapse-related Quality of life [[ Time Frame: 12 months after intervention ]]

    This will be assessed using a validated questionnaire (Prolapse Quality of Life questionnaire P-QoL) The questionnaire contains 9 domains. Each answer of the patient will have values that range between 1 to 4 or 1 to 5 for the 1st question only). (1 very good 4/5 very poor). There is no overall score. A symptomatic woman might have only one domain impaired and another one might have all domains impaired. We consider both of them symptomatic but in different or same aspects of quality of life. To differentiate different domains, it is important for the decision of our surgery (we will be careful in shortening and narrowing a vagina of a woman who had only a preoperative high (impaired) Personal relationships domain score and other domains in the normal range). This will also help us in the follow up visits.

  2. Failure (%) [[ Time Frame: 12 months after intervention ]]

    Recurrence rate

  3. Complications [[ Time Frame: 12 months after intervention ]]

    İnjury ( bowel, intestinal, blood vessel injuries, mesh erosions)

  4. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [[ Time Frame: 12 months after intervention ]]

    The PISQ-12 is a self-adminestered questionnaire that evaluates sexual function of women with pelvic organ prolapse or urinary incontinence. The questionnaire has 12 items. Other than the first 4 questions that are scored from 4 to 0, all questions are scored from 0 to 4. The total score is calculated with totaling the score of each question. The maximum score is 48. Higher scores show good sexual functioning of women.

  5. Incontinence Impact Questionnaire (IIQ-7) [[ Time Frame: 12 months after intervention ]]

    evaluating the impact of urinary incontinence

  6. Pelvic Floor Distress Inventory (PFDI - 20) [[ Time Frame: 12 months after intervention ]]

    evaluating the bowel, bladder, or pelvic symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse
Exclusion Criteria:
  • Women not eligible for surgery for medical or anesthesiological reasons

  • Inability to comprehend questionnaires

  • Inability to give informed consent

  • Inability to return for a review

  • Prior laparoscopic prolapse repair

  • Prior vaginal mesh prolapse procedure

  • Severe cardiovascular or respiratory disease

  • Women who don't want uterine preserving surgery

  • Pregnancy

  • Age <18 years, Age >45 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kanuni Sultan Suleyman Training and Research Hospital İstanbul Turkey 34307

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Ozan Karadeniz, MD, Kanuni Sultan Suleyman Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozan Karadeniz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05143658
Other Study ID Numbers:
  • KanuniSSS
First Posted:
Dec 3, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozan Karadeniz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022