Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse

NCT03722563 | Completed

• 1 other identifier: TLHSvsTLHLS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse

Conditions

Pelvic Organ Prolapse

Keywords

lateral suspension; laparoscopic hysterectomy; pelvic organ prolapse; sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• Rate of objective cure

  Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system

  12 months

Secondary Outcomes (3)

• Patient Global Impression of Improvement (PGI-I)

  12 months

• International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)

  12 months

• International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)

  12 months

Study Arms (2)

TLHS

ACTIVE COMPARATOR

total laparoscopic hysterectomy with sacrocolpopexy will be performed

Procedure: total laparoscopic hysterectomy with sacrocolpopexy

TLHLS

EXPERIMENTAL

total laparoscopic hysterectomy with lateral suspension will be performed

Procedure: total laparoscopic hysterectomy with lateral suspension

Interventions

total laparoscopic hysterectomy with sacrocolpopexy PROCEDURE

Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy

TLHS

total laparoscopic hysterectomy with lateral suspension PROCEDURE

Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy

TLHLS

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management

You may not qualify if:

• Patients that are not candidates for general anesthesia or laparoscopy
• Inability to consent
• history of hysterectomy
• history of anterior or apical pelvic organ prolapse surgery
• history of urinary incontinence surgery
• pregnancy or breast-feeding during the study period
• suspicious adnexal masses or other factors that may indicate pelvic malignancy

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Bekir Sıtkı İsenlik, MD

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: January 8, 2019
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

TU (1)