Safety and Efficacy of Different Procedures of Colpocleisis: a Randomized Controlled Trial

NCT ID: NCT06482697

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-11-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

total colpocleisis

Group Type: ACTIVE_COMPARATOR

total colpocleisis

Intervention Type: PROCEDURE

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)

Group Type: EXPERIMENTAL

partial colpocleisis (LeFort)

Intervention Type: PROCEDURE

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.

Interventions

total colpocleisis

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lan Zhu

OTHER

Sponsor Role: lead

Responsible Party

Lan Zhu

Director of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Central Contacts

Ying Zhou, MD

Role: CONTACT

shellypumch@163.com

+8613681253992

Other Identifiers

K5441

Identifier Type: -

Identifier Source: org_study_id