Uterine Preserving Apical Prolapse Correction With Laparoscopic Lateral Mesh Suspension: Initial Experience by Defining Anatomic and Subjective Success
Sponsor study identifier
observational
15
0 countries
N/A
Study Start
November 1, 2016
Actual (reported)Primary Completion
January 12, 2018
Actual (reported)Study Completion
February 5, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 5, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2016
Actual (reported)April 1, 2017
Actual (reported)January 2, 2018
Actual (reported)January 12, 2018
Actual (reported)February 5, 2018
Actual (reported)Change from baseline POP-Q measurements (mm) at 18th month.
Prolapse degree; Point Ba/C/Bp
18 months
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
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.
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
Symptomatic women with pelvic organ prolapse
15 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2017
First Posted
January 2, 2018
Study Start
November 1, 2016
Actual (reported)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.
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Primary Completion
January 12, 2018
Actual (reported)Study Completion
February 5, 2018
Actual (reported)Last Updated
February 7, 2018
Record last verified: 2018-02
Study Protocol
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Source: ClinicalTrials.gov.
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