Clinical trial NCT05586984: Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
Official title: A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Uterine Prolapse
Keywords: Pelvic organ prolapse
Laparoscopic uterine lateral suspension
Transvaginal sacrospinous ligament fixation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Anatomical outcome
timeFrame: 5 years
measure: Functional outcome
timeFrame: 5 years
measure: Sexual function outcome
timeFrame: 5 years
measure: Urodynamic outcome
timeFrame: 6 months
Other outcomes:
measure: Safety outcome
timeFrame: 5 years
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References: