- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06418438
A Randomized Controlled Trail of Uterosacral Ligament Suspension in the Treatment of Pelvic Organ Prolapse
May 13, 2024 updated by: Lan Zhu
To Compare the Clinical Efficacy and Safety of Laparoscopic Uterosacral Ligament Suspension With or Without Hysterectomy in the Treatment of POP
Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden.
The lifetime risk of undergoing surgery for POP is 12.6%.
Surgery is an important treatment modality for POP, and currently, there are various surgical procedures used in clinical practice, but there is still no clear consensus on which procedure is superior.
Autologous tissue repair remains crucial in pelvic floor reconstruction surgery, and high uterosacral ligament suspension (HUSLS) via a vaginal approach is a classic corrective procedure for central pelvic defects.
However, with the development of minimally invasive techniques, laparoscopic uterosacral ligament suspension (LUSLS) has been widely used in the field of pelvic floor reconstruction.
Compared to the vaginal approach, LUSLS is easier to perform, has a shorter learning curve, provides better exposure of the ureters, and allows for higher-quality suture placement under safe conditions.
The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation, with the core concern being the risk of postoperative recurrence.
High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures.
Its advantages include shorter operation time, less blood loss, and the preservation of the patient's fertility.
Many women request uterine preservation for various reasons.
Therefore, high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension.
Previous studies have found that approximately 40% of patients with pelvic organ prolapse have concurrent cervical elongation.
For patients with cervical elongation, symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina.
Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction, making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation.
Based on long-term observational studies, the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation.
This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal, providing more treatment options for future patients with pelvic organ prolapse and cervical elongation.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
314
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ying Zhou, MD
- Phone Number: +8613681253992
- Email: shellypumch@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years with symptomatic stage II or higher uterine prolapse (C ≥ +1cm) and gynecological ultrasonography confirming cervical length ≥ 4cm. Concurrent anterior and/or posterior vaginal wall prolapse may be present.
- Preoperative pelvic ultrasound and cervical screening show no abnormalities.
- The patient does not have a desire for future fertility.
- Willingness and ability to adhere to the follow-up treatment plan.
- Competence to provide informed consent.
Exclusion Criteria:
- Suspected untreated lower genital tract tumor, accompanied by other uterine, ovarian, and cervical lesions requiring surgical intervention, indicating contraindication for uterine preservation.
- Patients with a history of total hysterectomy/subtotal hysterectomy.
- Patients who have previously undergone pelvic organ prolapse surgery or other pelvic floor surgeries.
- Patients with contraindications for laparoscopic surgery, such as intestinal obstruction.
- Patients with intestinal hernia.
- Patients with gynecological and urinary tract infections, anticoagulant therapy, coagulation disorders, previous pelvic radiotherapy, as well as neurological or medical conditions affecting bladder and bowel function (such as multiple sclerosis, spinal cord injury, or residual neurological dysfunction caused by stroke), and patients with underlying conditions such as chronic pelvic pain, who are at higher risk for surgery.
- Simultaneous anti-urinary incontinence surgery is required for this procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laparoscopic uterosacral ligament suspension with hysterectomy
|
After anesthesia, bladder stone removal patients undergo laparoscopic hysterectomy.
The adnexa are coagulated and cut, and the bladder peritoneal reflection is opened.
The uterus is removed transvaginally.
Next, laparoscopic uterosacral ligament suspension is performed.
The right and left uterosacral ligaments are freed and sutured to lift the residual end.
|
Experimental: Laparoscopic uterosacral ligament suspension with cervical amputation
|
After anesthesia, bladder stone removal patients undergo cervical amputation surgery.
The cervix is exposed and elevated using Allis forceps.
A dilator is used to expand the cervix, and an incision is made on the anterior vaginal wall.
The cervix is excised and shaped using the Sturmdorf method.
Afterward, laparoscopic uterosacral ligament suspension is performed.
The right and left uterosacral ligaments are freed and sutured to lift the uterus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The composite success rate at the one-year follow-up
Time Frame: At the one-year follow-up
|
|
At the one-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lan Zhu, MD, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
May 13, 2024
First Submitted That Met QC Criteria
May 13, 2024
First Posted (Actual)
May 17, 2024
Study Record Updates
Last Update Posted (Actual)
May 17, 2024
Last Update Submitted That Met QC Criteria
May 13, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K5787
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pelvic Organ Prolapse
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Clinical Trials on Laparoscopic uterosacral ligament suspension with hysterectomy
-
Kaiser PermanenteMassachusetts General HospitalUnknownProlapse of Vaginal Vault After HysterectomyUnited States
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University Hospitals Cleveland Medical CenterUniversity of Pittsburgh; The Cleveland Clinic; Duke University; Case Western Reserve... and other collaboratorsRecruitingUterine ProlapseUnited States
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The Methodist Hospital Research InstituteUnknownVaginal Vault Prolapse | Post-Hysterectomy Vaginal Vault Prolapse | Prolapse, VaginalUnited States
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Brigham and Women's HospitalTerminatedUterine ProlapseUnited States
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NICHD Pelvic Floor Disorders NetworkBoston Scientific CorporationActive, not recruiting
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B.P. Koirala Institute of Health SciencesNot yet recruiting
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Antalya Training and Research HospitalCompleted
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Health Science University Zeynep Kamil Women and...RecruitingPelvic Organ Prolapse | Prolapse Bladder | Prolapse UterusTurkey
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University Hospital Inselspital, BerneRecruiting
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Loma Linda UniversityActive, not recruitingPelvic Organ Prolapse | Cystocele | Rectocele | EnteroceleUnited States