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

Antalya Training and Research Hospital

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: total laparoscopic hysterectomy with sacrocolpopexy; Procedure: total laparoscopic hysterectomy with lateral suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT03722563

TLHSvsTLHLS

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

TLHS

Active Comparator group

Description:

total laparoscopic hysterectomy with sacrocolpopexy will be performed

Treatment:

Procedure: total laparoscopic hysterectomy with sacrocolpopexy

TLHLS

Experimental group

Description:

total laparoscopic hysterectomy with lateral suspension will be performed

Treatment:

Procedure: total laparoscopic hysterectomy with lateral suspension