Safety and Efficacy of Different Procedures of Colpocleisis: a Randomized Controlled Trial
ConditionPelvic Organ Prolapse
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age70-90
SponsorLan Zhu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
total colpocleisis
Procedure/SurgeryTotal 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/SurgeryLeFort 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.
Treatment groups
330 Participants
are divided into 2 treatment groupsGroup A: total colpocleisisActive comparator 1 intervention
Group B: partial colpocleisis (LeFort)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at the perioperative period and three months of follow-upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lan Zhu
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov
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