Clinical trial NCT06903988: Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
Official title: A Randomized Controlled Study on the Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse (POP)
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. Patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. Follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. The primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. We hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. According to the POP-Q classification, patients who meet any of the following conditions: a. Patients with anterior wall prolapse of stage III or higher; b. Patients with apical prolapse of stage III or higher;
3. Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
4. Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
5. Patients who have received education at the primary school level or above;
6. Patients who are able to visit the hospital for examinations;
7. Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.

Exclusion Criteria:

1. Patients who have previously undergone surgery for pelvic organ prolapse (POP);
2. Patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation;
3. Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.

Primary outcomes:
measure: Surgical success rate
timeFrame: From enrollment to the end of surgery at 1 year
Secondary outcomes:
measure: Incidence of urinary retention after catheter removal
timeFrame: From enrollment to the end of surgery at 3 days
measure: Differences in the severity of overactive bladder (OAB) after surgery
timeFrame: 1 month, 3 months, 6 months and 1 year post-surgery
measure: Differences in the severity of urinary incontinence after surgery
timeFrame: 1 month, 3 months, 6 months and 1 year post-surgery
measure: Differences in the severity of pelvic floor dysfunction after surgery
timeFrame: 1 month, 3 months, 6 months and 1 year post-surgery
measure: Differences in quality of life after surgery
timeFrame: 1 month, 3 months, 6 months and 1 year post-surgery
measure: Differences in patients' satisfaction
timeFrame: 1 month, 3 months, 6 months and 1 year post-surgery
measure: Postoperative Pain
timeFrame: 1 month, 3 months, 6 months and 1 year post-surgery
Other outcomes:
measure: Mesh-related complications
timeFrame: From enrollment to the end of surgery at 1 year
measure: Duration of surgery
timeFrame: Intraoperative
measure: Blood loss
timeFrame: From enrollment to the end of surgery at 1 year
measure: Change in hemoglobin level
timeFrame: From enrollment to the end of surgery at 1 year
measure: Hospital stay duration
timeFrame: From enrollment to the end of surgery at 1 year
measure: Number of patients with surgical complications
timeFrame: From enrollment to the end of surgery at 1 year
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References: