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

NCT05143658 | Completed

• 1 other identifier: KanuniSSS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

pectopexy; lateral suspension; pelvic organ prolapse; uterine sparing; laparoscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Prolapse-related Quality of life

  [ Time Frame: 12 months after intervention ]

• Failure (%)

  [ Time Frame: 12 months after intervention ]

• Complications

  [ Time Frame: 12 months after intervention ]

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  [ Time Frame: 12 months after intervention ]

• Incontinence Impact Questionnaire (IIQ-7)

  [ Time Frame: 12 months after intervention ]

Study Arms (2)

Laparoscopic Lateral Suspension Group (LLS)

ACTIVE COMPARATOR

Anterior and apical prolapse repair via LLS

Procedure: LLS versus LP

Laparoscopic Pectopexy (LP)

EXPERIMENTAL

Anterior and apical prolapse repair via LP

Procedure: LLS versus LP

Interventions

LLS versus LP PROCEDURE

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

Laparoscopic Lateral Suspension Group (LLS); Laparoscopic Pectopexy (LP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ozan Karadeniz, MD

  Kanuni Sultan Suleyman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 3, 2021
• Study Start: December 6, 2021
• Primary Completion: December 6, 2021
• Study Completion: March 4, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

TU (1)