Pelvic Organ ProlapseNCT06482697
Safety and Efficacy of Different Procedures of Colpocleisis: a Randomized Controlled Trial
A study testing total colpocleisis and partial colpocleisis (LeFort) in people with Pelvic Organ Prolapse, run by Lan Zhu.
Trial summary
Background: Pelvic organ prolapse (POP) is one of the most common benign gynecological diseases among middle-aged and elderly women, which severely affects the quality of life of patients. Colpocleisis for the treatment of POP has a high success rate and low incidence of complications. Read more about this study
- Who is it for?
- Ages 70 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- total colpocleisis and partial colpocleisis (LeFort)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Symptomatic POP patients (POP-Q ≥ stage II) with no need for vaginal sexual life, aged 70 or older
- Patients who are eligible for long-term follow-up for at least one year
- Patients who agree to participate in this study and have signed the informed consent form.
Who cannot join
- During the acute phase of infection of the internal and/or external genital organs
- Patients who cannot undergo hysterectomy through the vagina
- Patients who have previously undergone hysterectomy or subtotal hysterectomy
- Patients diagnosed with stress urinary incontinence by preoperative urodynamic examination
- Patients who are unable to take care of themselves, have cognitive impairment, are bedridden for a long time, and cannot complete follow-up
- Patients with severe comorbidities that prevent them from undergoing surgery
- Patients with coagulation dysfunction or those who are receiving therapeutic anticoagulant therapy
- Patients whom the researcher considers may have other medical, psychological diseases, or social factors that prevent them from cooperating to complete this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Compare the Clinical Efficacy and Complications of Total Colpocleisis and Partial Colpocleisis in the Treatment of Pelvic Organ Orolapse
Background: Pelvic organ prolapse (POP) is one of the most common benign gynecological diseases among middle-aged and elderly women, which severely affects the quality of life of patients. Colpocleisis for the treatment of POP has a high success rate and low incidence of complications. The classic colpocleisis is divided into total colpocleisis and partial colpocleisis (LeFort). However, there are no long-term follow-up large-scale randomized trials to compare the clinical efficacy, complications between the two surgical methods. This study aims to compare the incidence of surgical complications, objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate in patients with pelvic organ prolapse treated by total colpocleisis and LeFort.
Methods: This trial is a prospective, multicenter, randomized, non-blinded non-inferiority trial, comparing the application of hysterectomy with total colpocleisis and LeFort in symptomatic pelvic organ prolapse patients with no need for vaginal sexual life, and aged ≥70 years. The primary outcome measure is the incidence of surgical complications, including perioperative and postoperative complications within 3 months, as well as the incidence of severe complications. Secondary outcomes include the objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate at 3 months, 1 year, and 2 years post-surgery. This study is a non-inferiority study, based on the literature reports that the incidence of complications for colpocleisis and LeFort with hysterectomy are 11.4% and 7.0%, respectively, with a non-inferiority boundary value of 5%, α=0.025 (one-sided), β=0.2, and a ratio of 1:1 between the two groups. The sample size is calculated to be n=296, considering a 10% dropout rate, a total of 330 patients need to be included.
Discussion: This is a randomized multicenter clinical trial that will provide evidence to demonstrate the differences in complications and efficacy between colpocleisis and LeFort with hysterectomy.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- total colpocleisis, partial colpocleisis (LeFort)
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total colpocleisisProcedure or surgery
Total colpocleisis refers to the process where, during the dissection of the anterior and posterior vaginal walls to remove the vaginal mucosa, no holes are left. When suturing, the anterior and posterior vaginal walls are completely interrupted with mattress sutures, and no holes are left on either side or at the top of the vagina.
partial colpocleisis (LeFort)Procedure or surgery
LeFort involves the removal of a rectangular piece of mucosa from the anterior and posterior walls of the vagina, leaving a strip of mucosa 2 to 3 cm wide on each side of the vagina. The dissection is carried out close to the vaginal mucosa while preserving the vaginal bladder fascia as much as possible, creating channels on both sides of the vagina.
| Study group | Role | What they receive |
|---|---|---|
| total colpocleisis | Active comparator | Not described Receives: Procedure: total colpocleisis |
| partial colpocleisis (LeFort) | Experimental | Not described Receives: Procedure: partial colpocleisis (LeFort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complication rate
The surgical complication rates include the incidence of complications during the perioperative period and within 3 months postoperatively, as well as the incidence of severe complications.
Measured: at the perioperative period and three months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lan Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lan Zhu, Peking Union Medical College Hospital
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482697
- Sponsor's protocol ID
- K5441
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Clinical Efficacy and Complications of Total Colpocleisis and Partial Colpocleisis in the Treatment of Pelvic Organ Orolapse
- ClinicalTrials.gov ID
- NCT06482697
- Acronym / sponsor ID
- K5441
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Lan ZhuUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Pelvic organ prolapse (POP) is one of the most common benign gynecological diseases among middle-aged and elderly women, which severely affects the quality of life of patients. Colpocleisis for the treatment of POP has a high success rate and low incidence of complications. The classic colpocleisis is divided into total colpocleisis and partial colpocleisis (LeFort). However, there are no long-term follow-up large-scale randomized trials to compare the clinical efficacy, complications between the two surgical methods. This study aims to compare the incidence of surgical complications, objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate in patients with pelvic organ prolapse treated by total colpocleisis and LeFort.
Methods: This trial is a prospective, multicenter, randomized, non-blinded non-inferiority trial, comparing the application of hysterectomy with total colpocleisis and LeFort in symptomatic pelvic organ prolapse patients with no need for vaginal sexual life, and aged ≥70 years. The primary outcome measure is the incidence of surgical complications, including perioperative and postoperative complications within 3 months, as well as the incidence of severe complications. Secondary outcomes include the objective surgical success rate, subjective satisfaction rate, pelvic floor symptom improvement rate, and regret rate at 3 months, 1 year, and 2 years post-surgery. This study is a non-inferiority study, based on the literature reports that the incidence of complications for colpocleisis and LeFort with hysterectomy are 11.4% and 7.0%, respectively, with a non-inferiority boundary value of 5%, α=0.025 (one-sided), β=0.2, and a ratio of 1:1 between the two groups. The sample size is calculated to be n=296, considering a 10% dropout rate, a total of 330 patients need to be included.
Discussion: This is a randomized multicenter clinical trial that will provide evidence to demonstrate the differences in complications and efficacy between colpocleisis and LeFort with hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total colpocleisis | Active comparator | Procedure: total colpocleisis |
| partial colpocleisis (LeFort) | Experimental | Procedure: partial colpocleisis (LeFort) |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Symptomatic POP patients (POP-Q ≥ stage II) with no need for vaginal sexual life, aged 70 or older
- Patients who are eligible for long-term follow-up for at least one year
- Patients who agree to participate in this study and have signed the informed consent form.
Key exclusion criteria (8 listed)
- During the acute phase of infection of the internal and/or external genital organs
- Patients who cannot undergo hysterectomy through the vagina
- Patients who have previously undergone hysterectomy or subtotal hysterectomy
- Patients diagnosed with stress urinary incontinence by preoperative urodynamic examination
- Patients who are unable to take care of themselves, have cognitive impairment, are bedridden for a long time, and cannot complete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total colpocleisisTotal colpocleisis refers to the process where, during the dissection of the anterior and posterior vaginal walls to remove the vaginal mucosa, no holes are left. When suturing, the anterior and posterior vaginal walls are completely interrupted with mattress sutures, and no holes are left on either side or at the top of the vagina. | Procedure or surgery | total colpocleisis |
| partial colpocleisis (LeFort)LeFort involves the removal of a rectangular piece of mucosa from the anterior and posterior walls of the vagina, leaving a strip of mucosa 2 to 3 cm wide on each side of the vagina. The dissection is carried out close to the vaginal mucosa while preserving the vaginal bladder fascia as much as possible, creating channels on both sides of the vagina. | Procedure or surgery | partial colpocleisis (LeFort) |
Primary outcome
Surgical complication rate
Time frame: at the perioperative period and three months of follow-up
The surgical complication rates include the incidence of complications during the perioperative period and within 3 months postoperatively, as well as the incidence of severe complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing total colpocleisis and partial colpocleisis (LeFort) in people with Pelvic Organ Prolapse, run by Lan Zhu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, MD (+8613681253992, shellypumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complication rate (time frame: at the perioperative period and three months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.