Application of improved mesh and instrumental in laparoscopic sacrocolpopexy for severe pelvic organ prolapse

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ONN-16009439
• Date of registration: 2016-10-15
• Prospective Registration: No
• Primary sponsor: Shanghai First Maternity and Infant Hospital
• Public title: Application of improved mesh and instrumental in laparoscopic sacrocolpopexy for severe pelvic organ prolapse
• Scientific title: Application of improved mesh and instrumental in laparoscopic sacrocolpopexy for severe pelvic organ prolapse
• Date of first enrolment: 2016-10-01
• Target sample size: Group A:100;Group B:100;Group C:100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=16143
• Study type: Observational study
• Study design: Non randomized control
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Huimin Shu
• Affiliation: Shanghai First Maternity and Infant Hospital

• Name: Zhiyuan Dai
• Affiliation: Shanghai First Maternity and Infant Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged from 18 Years to 80 years;
2. Subject has been diagnosed with uterine prolapse or posthysterectomy vaginal vault prolapse (symptomatic POP-Q stage III or higher) requiring surgical repair;
3. Subject has no uncontrolled systemic disease;
4. Subject is unwilling or unable to give valid informed consent.
Exclusion criteria: 1. Investigator determines subject is not a candidate for surgical repair of her genital prolapse (lack of symptomatic or imaging basis;
2. Subject has active or latent systemic disease (including server liver diseasekidney diseaserespiratory diseasecardiovascular diseaseepilepsy or uncontrolled diabetes;
3. Subject is currently pregnant or intends to become pregnant during the study period;
4. Subject has gynecological or other cancer;
5. Subject is on any medication with could result in compromised immune response, such as immune modulators;
6. Subject is unwilling or unable to give valid informed consent;
7. Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits;
8. Subject with contraindications for laparoscopy.

Age minimum: 18
Age maximum: 80
Gender: Female

Health Condition(s) or Problem(s) studied

pelvic organ prolapse

Intervention(s)

Group A:Laproscopiccross-shaped sacrocolpopexy;Group B:Laproscopic Y-shaped sacrocolpopexy;Group C:SSLF+anterior pelvic reconstruction;

Primary Outcome(s)

POP-Q;pelvic MRI;

Source(s) of Monetary Support

Shanghai Shenkang Hospital Development Center