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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

70 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total colpocleisis

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)

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhou, MD

CONTACT

[email protected]

+8613681253992

Sponsors and collaborators

Lead sponsor

Lan Zhu

Other

Registry information

Official study title

To Compare the Clinical Efficacy and Complications of Total Colpocleisis and Partial Colpocleisis in the Treatment of Pelvic Organ Orolapse

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Jul 1, 2024
Registry last updated: Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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