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Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

F

Fatih Sultan Mehmet Training and Research Hospital

Status

Completed

Conditions

Pelvic Floor Prolapse
Pelvic Organ Prolapse

Treatments

Procedure: Laparoscopic lateral suspension with mesh
Diagnostic Test: Transperineal ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT03387202
FSM KAEHK

Details and patient eligibility

About

This study is aimed to share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes.

Full description

Vaginal length, bladder neck mobility and pelvic floor biometry with anteroposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative 18th months if available.

Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS) are used to assess subjective success in the preoperative and at postoperative 18th months if available.

,

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >18 years old symptomatic women with pelvic organ prolapse needing surgery.
  • Patients who are not comfortable with using or refusing pessary
  • Refusing sacrocolpopexy due to its serious surgical risk

Exclusion criteria

  • Patients who prefer sacrocolpopexy
  • Any cue for gynecologic oncological condition
  • Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse

Trial design

15 participants in 1 patient group

pelvic organ prolapse
Description:
Participants received "Laparoscopic lateral suspension with mesh" as part of routine medical care in apical prolapse, thus, the investigator does not assign a intervention but studies the effects.Vaginal length, bladder neck mobility and pelvic floor biometry with AP hiatal diameter and pelvic organ descent measurements are measured by Transperineal ultrasound to assess anatomic success in the preoperative and at postoperative 18th months. POP-Q assessment and translabial usg for objective success; Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS) are used to assess subjective success.
Treatment:
Diagnostic Test: Transperineal ultrasound
Procedure: Laparoscopic lateral suspension with mesh

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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