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

Lan Zhu

Status

Not yet enrolling

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: total colpocleisis

Procedure: partial colpocleisis (LeFort)

Study type

Interventional

Funder types

Other

Identifiers

NCT06482697

K5441

Details and patient eligibility

About

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.

Enrollment

330 estimated patients

Sex

Female

Ages

70 to 90 years old

Volunteers

No Healthy Volunteers

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