Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

NCT03387202 | Completed DMC

• 1 other identifier: FSM KAEHK
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse; Pelvic Floor Prolapse

Keywords

Pelvic Organ Prolapse; Translabial ultrasound; Transperineal ultrasound; Lateral Mesh Suspension; Descensus uteri; Laparoscopic pelvic organ prolapse repair

Outcome Measures

Primary Outcomes (1)

• Change from baseline POP-Q measurements (mm) at 18th month.

  Prolapse degree; Point Ba/C/Bp

  18 months

Secondary Outcomes (9)

• Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 18th month.

  18 months

• Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 18th month.

  18 months

• Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 18th month.

  18 months

• Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 18th month.

  18 months

• Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 18th month.

  18 months

Study Arms (1)

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.

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

Interventions

Laparoscopic lateral suspension with mesh 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

pelvic organ prolapse

Transperineal ultrasound 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.

Also known as: Translabial ultrasound

pelvic organ prolapse

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic women with pelvic organ prolapse

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: January 2, 2018
• Study Start: November 1, 2016
• Primary Completion: January 12, 2018
• Study Completion: February 5, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately, until the publishing
• Access Criteria: Study protocol can be sent upon request murat.yassa@gmail.com