Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fix… (NCT06903988) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
China86 participantsStarted 2025-04-05
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years;
. 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;
. Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
. Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
. Patients who have received education at the primary school level or above;
. Patients who are able to visit the hospital for examinations;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical success rate
Timeframe: From enrollment to the end of surgery at 1 year
. Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.
Exclusion criteria
. Patients who have previously undergone surgery for pelvic organ prolapse (POP);
. 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;
. Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.