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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: LLS versus LP

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ömer Ünal, MD; Phone Number: +905533888766; Email: dr.omer-unal@hotmail.com

Study Locations

• Turkey
  • İstanbul, Turkey, 34307
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective cure rate of prolapse	Provided by the patient's feeling of the "Absence of a bulge in the vagina"	[ Time Frame: 12 months after intervention ]
Objective success	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	[ Time Frame: 12 months after intervention ]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse-related Quality of life	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.	[ Time Frame: 12 months after intervention ]
Failure (%)	Recurrence rate	[ Time Frame: 12 months after intervention ]
Complications	İnjury ( bowel, intestinal, blood vessel injuries, mesh erosions)	[ Time Frame: 12 months after intervention ]
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	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.	[ Time Frame: 12 months after intervention ]
Incontinence Impact Questionnaire (IIQ-7)	evaluating the impact of urinary incontinence	[ Time Frame: 12 months after intervention ]
Pelvic Floor Distress Inventory (PFDI - 20)	evaluating the bowel, bladder, or pelvic symptoms	[ Time Frame: 12 months after intervention ]

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopy; pelvic organ prolapse; lateral suspension; pectopexy; uterine sparing
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: KanuniSSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No