Clinical trials

This study intends to establish a screening cohort for HPV infection and related tumors in areas with high incidence of HIV infection, explore the screening of cervical cancer and anal cancer and the prognosis management model of precancerous lesions in HIV-infected women, and provide a scientific basis for the formulation of malignant tumor screening policies for this population in my country. In addition, this study intends to characterize the cervical, vaginal, and intestinal microecological characteristics of women with different HIV/HPV infection status, so as to explore the impact of cervical, vaginal, and intestinal microecological characteristics on persistent HPV infection or CIN/cancer progression.

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.

Background: Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women, and it has a significant negative impact on women's social, physical, and psychological health. Sacrospinous ligament fixation (SSLF) is one of the main surgical procedures for reconstructing pelvic floor defects. In previous studies, the ischial spine fascia fixation (ISFF) technique developed by our team has been shown to be a safe and effective alternative to SSLF. However, both procedures have inadequate support for the anterior vaginal wall. Therefore, based on the traditional ISFF, we fix the anterior vaginal wall to the ipsilateral ischial spine fascia to enhance support for the anterior vaginal wall. This modified procedure is called modified ISFF. This trial aims to compare the subjective and objective therapeutic effects, recurrence rates, quality of life, perioperative parameters, and complications of modified ISFF and SSLF in the treatment of patients with pelvic organ prolapse of degrees II-IV. Methods: This trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite surgical success rate at one-year follow-up, defined as the absence of subjective vaginal bulge symptoms, no need for retreatment, and absence of POP-Q points at or beyond the hymen or vaginal introitus, i.e., Aa, Ba, C, Ap, Bp all \< 0 cm. The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score, subjective improvement in quality of life evaluated by questionnaires (PFIQ-7, PFDI-20, PISQ-12, and PGI-I), perioperative parameters (operation time, blood loss, length of hospital stay, pain VAS score, hospital costs), and complications. Data analysis will be conducted according to the intention-to-treat principle. Based on a composite success rate of 88% and a non-inferiority margin of -10% (one-sided α = 0.025, β = 0.2), 370 patients will be recruited from 9 centers, including a 10% dropout rate. The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications. Discussion: This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse. If modified ISFF is proven to be non-inferior to SSLF, it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors.

Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden. The lifetime risk of undergoing surgery for POP is 12.6%. Surgery is an important treatment modality for POP, and currently, there are various surgical procedures used in clinical practice, but there is still no clear consensus on which procedure is superior. Autologous tissue repair remains crucial in pelvic floor reconstruction surgery, and high uterosacral ligament suspension (HUSLS) via a vaginal approach is a classic corrective procedure for central pelvic defects. However, with the development of minimally invasive techniques, laparoscopic uterosacral ligament suspension (LUSLS) has been widely used in the field of pelvic floor reconstruction. Compared to the vaginal approach, LUSLS is easier to perform, has a shorter learning curve, provides better exposure of the ureters, and allows for higher-quality suture placement under safe conditions. The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation, with the core concern being the risk of postoperative recurrence. High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures. Its advantages include shorter operation time, less blood loss, and the preservation of the patient's fertility. Many women request uterine preservation for various reasons. Therefore, high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension. Previous studies have found that approximately 40% of patients with pelvic organ prolapse have concurrent cervical elongation. For patients with cervical elongation, symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina. Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction, making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation. Based on long-term observational studies, the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation. This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal, providing more treatment options for future patients with pelvic organ prolapse and cervical elongation.