Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Medstron Medical Co.Ltd | UNKNOWN |
| LinkDoc Technology (Beijing) Co. Ltd. | INDUSTRY |
| Chinese Academy of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 90% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-cut mesh procedure | Active Comparator | This procedure is transvaginal mesh implantation surgery for POP patients. Self-cut mesh procedure is an economic pelvic reconstructive surgical operation with use of specially designed puncture needles and self-cut mesh, which mainly provide anterior and apical compartments support, with posterior compartment reinforced by bridge technique repair. The mesh pieces used in this surgery was cut from a single piece of mesh material(TiLOOP 10*15cm) which is much cheaper and readily available. Patients could have transvaginal hysterectomy concomitantly. |
|
| mesh-kit procedure | Active Comparator | This procedure is transvaginal mesh implantation surgery for POP patients.Mesh-kit procedure is refered to pelvic floor reconstructive surgery with titanium-coated meshes kit(TiLOOP TOTAL6).Patients could have transvaginal hysterectomy concomitantly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pelvic floor reconstructive surgery | Procedure | transvaginal mesh implantation for pelvic organ prolapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| surgical "success" | Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms, and no additional treatment for prolapse(surgical or pessary use). Anatomic cure is defined as leading edge above the hymen (i.e Ba, C, Bp<0 cm) Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20 (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area? | up to 36 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| anatomic outcomes | anatomic outcome of each vaginal segment( anterior, posterior and apical) using POP-Q score. | up to 36 months after operation |
| symptomatic improvement using validated instruments(PFIQ-7) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 86-10-69155749 | zhu_julie@sina.com | |
| Juan Chen | Contact | 86-10-69155749 | pumchcj@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36112377 | Derived | Chen J, Yu J, Morse A, Tao G, Gong J, Wang B, Wang Y, Ababaikeli G, Jiang X, Liu P, Zhang X, Nisier H, Wang P, Funfgeld C, Huang K, Zhang H, Sun X, Zhu L. Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Noninferiority Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231869. doi: 10.1001/jamanetworkopen.2022.31869. | |
| 32102687 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.
Relief of symptoms using validated instruments(PFIQ-7) .
| up to 36 months after operation |
| symptomatic improvement using validated instruments(PFDI-20) | Relief of symptoms using validated instruments(PFDI-20) . | up to 36 months after operation |
| symptomatic improvement using validated instruments(PISQ-12) | Relief of symptoms using validated instruments(PISQ-12) | up to 36 months after operation |
| symptomatic improvement using patient global impression of change (PGI-C) | Relief of symptoms using patient global impression of change (PGI-C) | up to 36 months after operation |
| intraoperative and post operative complications | using IUGA/ICS joint terminology CTS coding system and dingo system | up to 36 months after operation |
| post operative pain | visual analogue scales (VAS) were used to evaluate the degree of pain. | within 3 days after operation |
| Hospital costs | hospitlization expenses | up to 4 weeks after operation |
| Fosha Maternal and Child Health Care Hospital | Recruiting | Foshan | Guangdong | China |
|
| The First Affiliated Hospital of Guangzhou Medical College | Recruiting | Guangzhou | Guangdong | China |
|
| Changsha Maternal and Child Health Care Hospital | Recruiting | Changsha | Hunan | China |
|
| The second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
|
| Wuxi Maternal and Child Health Care Hospital | Recruiting | Wuxi | Jiangsu | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
|
| Shanxi Provincial People's Hospital | Recruiting | Xi’an | Shanxi | China |
|
| Sichuan University West China Second University Hospital | Recruiting | Chengdu | Sichuan | China |
|
| the First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | China |
|
| the People's Hospital of Xinjiang Uygur Autonomous Region | Recruiting | Ürümqi | Xinjiang | China |
|
| Derived |
| Chen J, Yu J, Morse A, Funfgeld C, Huang K, Gong J, Tao G, Wang B, Wang Y, Jiang X, Ababaikeli G, Liu P, Nisier H, Zhang X, Wang P, Sun X, Zhu L. Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial. Trials. 2020 Feb 26;21(1):226. doi: 10.1186/s13063-019-3966-3. |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided