Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

NCT05586984 | Recruiting

• 1 other identifier: 111-NCKUH-CTC--IIT
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Keywords

Pelvic organ prolapse; Laparoscopic uterine lateral suspension; Transvaginal sacrospinous ligament fixation

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Composite outcome of subjective and objective recurrence of uterine prolapse.

  5 years

Secondary Outcomes (4)

• Anatomical outcome

  5 years

• Functional outcome

  5 years

• Sexual function outcome

  5 years

• Urodynamic outcome

  6 months

Other Outcomes (1)

• Safety outcome

  5 years

Study Arms (2)

Laparoscopic uterine lateral suspension

Laparoscopic uterine lateral suspension for apical prolapse. Concomitant anterior and posterior colporrhaphy may be performed.

Procedure: Laparoscopic uterine lateral suspension

Transvaginal sacrospinous fixation

Uterus-preserving transvaginal sacrospinous fixation for apical prolapse. Concomitant anterior and posterior colporrhaphy may be performed.

Procedure: Transvaginal sacrospinous fixation

Interventions

Laparoscopic uterine lateral suspension PROCEDURE

Laparoscopic uterine lateral suspension done with four trocar sites. Fix a 1.5cm\*32cm mesh to uterus at anterior lower segment and bilateral round ligaments by non-absorbable sutures (Surgilon 2-0, Ethicon, Norderstedt, Germany), and to lateral abdominal fascia by non-absorbable sutures (Prolene 1-0, Ethicon, Norderstedt, Germany). Reperitonization done to avoid mesh exposure in peritoneal cavity. Concomitant anterior and posterior colporrhaphy may be performed.

Laparoscopic uterine lateral suspension

Transvaginal sacrospinous fixation PROCEDURE

Transvaginal sacrospinous fixation done by hand suturing uterus to right sacrospinous ligament with non-absorbable suture (Prolene 1-0, Ethicon, Norderstedt, Germany). Concomitant anterior and posterior colporrhaphy may be performed.

Transvaginal sacrospinous fixation

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pelvic organ prolapse, predominantly apical prolapse, who had not received a previous surgical correction, and is willing to receive a uterine-preserving surgery for pelvic organ prolapse.

You may qualify if:

• older than 21 years old.
• uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system.
• patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation.
• patients who had or had not received conservative treatments for pelvic organ prolapse.
• patients able and willing to finish the questionnaire evaluation.

You may not qualify if:

• patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse.
• patient who had received a previous surgery for pelvic organ prolapse.
• patient with history of adverse events following a synthetic mesh.
• patients with chronic or acute pelvic pain.
• patients who had received abdominal or pelvic irradiation.
• patients who cannot receive either surgery due to comorbidity.
• patients pregnant or with future plan of pregnancy.
• patients with vaginal length less than 5cm.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

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

Central Study Contacts

Yu Fang Huang, MD

CONTACT

886-6-2353535; yufangh@ncku.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Yu Fang Huang

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: July 26, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)