Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

NCT ID: NCT03387202

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2018-02-05

Brief Summary

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.

Detailed 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.

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Conditions

Pelvic Organ Prolapse; Pelvic Floor Prolapse

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

pelvic organ prolapse

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.

Laparoscopic lateral suspension with mesh

Intervention Type: PROCEDURE

V-shaped ccm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J\&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3cmsuperoposterior to the anteriosuperior iliac spine.A grasper is introduced retroperitoneally through the subperitoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Broad ligament is lifted upward and tunnel is practiced in its lower third.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level

Transperineal ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Laparoscopic lateral suspension with mesh

V-shaped ccm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J\&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3cmsuperoposterior to the anteriosuperior iliac spine.A grasper is introduced retroperitoneally through the subperitoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Broad ligament is lifted upward and tunnel is practiced in its lower third.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level

Intervention Type: PROCEDURE

Transperineal ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Translabial ultrasound

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

MURAT YASSA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FSM KAEHK

Identifier Type: -

Identifier Source: org_study_id