A Multicenter, Randomized, Prospective, Controlled Study Comparing Uterine Preserving Laparoscopic Lateral Suspension With Mesh Versus Laparoscopic Sacrocervicopexy in the Treatment of Uterine Prolapse: A Randomized Controlled Trial
Sponsor study identifier
interventional
44
1 country
2
Study Start
January 24, 2018
Actual (reported)Primary Completion
March 14, 2019
Actual (reported)Study Completion
March 14, 2019
Actual (reported)This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 14, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 21, 2018
Actual (reported)January 24, 2018
Actual (reported)February 5, 2018
Actual (reported)March 14, 2019
Actual (reported)March 14, 2019
Actual (reported)Change from baseline POP-Q measurements (mm) at 12th month.
Prolapse degree; Point Ba/C/Bp
12 months for each participant
Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 12th month.
12 months for each participant
Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 12th month.
12 months for each participant
"Uterus-preserving Laparoscopic lateral suspension with mesh" technique will be performed in this arm.
"Uterus-preserving Laparoscopic sacrocervicopexy with mesh" technique will be performed in this arm.
V-shaped 2cm 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 3-4 cm superoposterior to the anterosuperior iliac spine.A grasper is introduced retroperitoneally through the sub-peritoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Round ligament is lifted upward and tunnel is practiced horizontally.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.
Fatih Sultan Mehmet Training and Research Hospital, Sancaktepe Campus
Istanbul, Sancaktepe, 34785, Turkey (Türkiye)
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Sisli, 34371, Turkey (Türkiye)
Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.
Niyazi Tug, As.Prof.
Chief of the Department
44 participants (actual enrollment reported by the registry).
First Submitted
January 21, 2018
First Posted
February 5, 2018
Study Start
The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 12th month.
12 months for each participant
Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 12th month.
12 months for each participant
Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 12th month.
12 months for each participant
The peritoneum over the sacral promontory is incised until the anterior longitudinal ligament is reached and ureters are identified. Peritoneal relaxing incision is made medial to the right ureter, down into the pelvis, posterior to the cervix and rectovaginal fascia, laterally to the rectum. The arm of the mesh is sutured to the posterior cervix by 2.0 prolene and fixated to the sacral promontory by either Tacker (Covidien) and/or 2.0 prolene as tension-free. Complete peritonisation of the mesh is performed.
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January 24, 2018
Primary Completion
March 14, 2019
Actual (reported)Study Completion
March 14, 2019
Actual (reported)Last Updated
March 18, 2019
Record last verified: 2019-03
Study Protocol
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