Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

NCT ID: NCT05586984

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2029-12-31

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.

Detailed Description

Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies.

Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include 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 of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laparoscopic uterine lateral suspension

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

Laparoscopic uterine lateral suspension

Intervention Type: 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.

Transvaginal sacrospinous fixation

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

Transvaginal sacrospinous fixation

Intervention Type: 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.

Interventions

Laparoscopic uterine lateral suspension

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.

Intervention Type: PROCEDURE

Transvaginal sacrospinous fixation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Fang Huang

Professor Yu Fang Huang

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu Fang Huang, MD

Role: CONTACT

yufangh@ncku.edu.tw

886-6-2353535 ext. 3104

Facility Contacts

Yu Fang Huang, MD

Role: primary

yufangh@ncku.edu.tw

886-6-2353535 ext. 3104

Other Identifiers

111-NCKUH-CTC--IIT

Identifier Type: -

Identifier Source: org_study_id