Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse

NCT03421457 | Completed DMC

• 1 other identifier: RCTPOPS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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.

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; Uterus preserving; hysteropexy; uterine-preserving; fertility-sparing; sacropexy; cervicopexy; sacrocervicopexy; sacrohysteropexy; mesh prolapse surgery

Outcome Measures

Primary Outcomes (1)

• Change from baseline POP-Q measurements (mm) at 12th month.

  Prolapse degree; Point Ba/C/Bp

  12 months for each participant

Secondary Outcomes (11)

• 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

• 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

Study Arms (2)

Lateral suspension

EXPERIMENTAL

"Uterus-preserving Laparoscopic lateral suspension with mesh" technique will be performed in this arm.

Procedure: Uterus-preserving laparoscopic lateral suspension with mesh

Sacrocervicopexy

EXPERIMENTAL

"Uterus-preserving Laparoscopic sacrocervicopexy with mesh" technique will be performed in this arm.

Procedure: Uterus-preserving laparoscopic sacrocervicopexy with mesh

Interventions

Uterus-preserving laparoscopic lateral suspension with mesh PROCEDURE

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.

Lateral suspension

Uterus-preserving laparoscopic sacrocervicopexy with mesh PROCEDURE

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.

Sacrocervicopexy

Eligibility Criteria

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

You may qualify if:

• \>18 years old
• \> Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse.
• Patients who are not comfortable with using or refusing pessary
• Wish to preserve the uterus

You may not qualify if:

• 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
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (2)

Fatih Sultan Mehmet Training and Research Hospital, Sancaktepe Campus

Istanbul, Sancaktepe, 34785, Turkey (Türkiye)

Location

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Sisli, 34371, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28417156 BACKGROUND

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 Officials

• Niyazi Tug, As.Prof.

  Chief of the Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider will be blind to the operation type. Outcomes will be assessed by a gynecologist who will be blind to the operation type, indications and complications. Assessor has wide experience in urogynecological sonography.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: February 5, 2018
• Study Start: January 24, 2018
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)