Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

Pelvic Organ Prolapse Clinical Trial

Official title:

A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586984
• Other study ID #: 111-NCKUH-CTC--IIT
• Status: Recruiting
• Start date: July 26, 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: October 2022
• Source: National Cheng-Kung University Hospital
• Contact: Yu Fang Huang, MD
• Phone: 886-6-2353535
• Email: yufangh[@]ncku.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome	Surgery-related complications and mesh-related long term complications.	5 years
Primary	Recurrence	Composite outcome of subjective and objective recurrence of uterine prolapse.	5 years
Secondary	Anatomical outcome	Comparison of total vaginal length (TVL), Ba, Bp points defined by POP-Q system.	5 years
Secondary	Functional outcome	Comparison of urination and defecation functions by Pelvic floor disability index-20 (PFDI-20).	5 years
Secondary	Sexual function outcome	Comparison of sexual function by Female Sexual Function Index (FSFI).	5 years
Secondary	Urodynamic outcome	Comparison of post residual urine amount, uroflowmetry, and 1-hour pad test.	6 months