Clinical trial NCT04213027: RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
Official title: Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Prolapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 320
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in prolapse women randomized to Sacrospinous ligament fixation (SSLF) and Ischial spinous fascia fixation (ISFF).

Detailed description: The population will include Chinese female patients with advanced apical prolapse (stage II-III) and who are undergoing Sacrospinous Ligament Fixation (SSLF) and Ischial spinous fascia fixation (ISFF) procedure using conventional surgical instruments without special instrument. After enrollment, standardized baseline data including demographics, POPQ evaluation, series of validated questionaires via interviews( PFDI-20, PFIQ-7, PISQ-12) will be collected by study personnel at the baseline visit. Eligible consenting patients will proceed to randomizations with equal probability of assignment to SSLF or ISFF. Randomization to either SSLF or ISFF will take place preoperatively by each clinical site using a random permutated block design. After index surgical intervention, scheduled follow-up will occur at 3, 6, 12, 24 and 36 months after the index surgery. At the follow-up visits, POPQ examination will be performed and an update of current medications, an assessment of new or continuing pelvic floor disorders, adverse events that occurred since the previous evaluation, and an assessment of health care costs. A series of validated instruments will be administered via interviews to including PFDI-20, PFIQ-7, PISQ-12, PGI-C.

Eligibility criteria: Inclusion Criteria:

1. Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
2. SSLF or ISFF is proceeded as described before，while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously.
3. Women who have been eligible for long-term follow-up.
4. Women who agreed to participate in the study and signed informed consent.

Exclusion Criteria:

1. Women who have surgical history for prolapse with mesh.
2. Women who have contraindication for surgical procedure
3. Women who are unable to comply with the study procedures

Primary outcomes:
measure: rate of surgical success
timeFrame: up to 36 months after operation
Secondary outcomes:
measure: rate of Postoperative recurrence
timeFrame: from 3 months after operation up to 36 months after operation
measure: visual analogue scales
timeFrame: up to 36 months after operation, usuallly within 3 days after operation
measure: changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)
timeFrame: up to 36 months after operation
measure: changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)
timeFrame: up to 36 months after operation
measure: changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)
timeFrame: up to 36 months after operation
measure: results of postoperative symptomatic improvement using patient global impression of change (PGI-C)
timeFrame: up to 36 months after operation
measure: intraoperative and post operative complications
timeFrame: up to 36 months after operation
Other outcomes:
Locations:
city: Hefei
country: China
facility: 2nd Affiliated hospital of Anhui Medical college
state: Anhui
city: Beijing
country: China
facility: 1st Affiliated hospital of PLA general hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Suzhou
country: China
facility: Suzhou City Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
affiliation: 1st Affiliated hospital of PLA general hospital
name: Yongxian Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai First Maternity and Infant Hospital
name: Zhiyuan Dai
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated hospital of Anhui Medical college
name: Wenyan Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Shan'xi Province Women's and Children's Hospital
name: Zhaoai Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Foshan Women's and Children's Hospital
name: Yuling Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou City Hospital
name: Shunyu Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou Women's and Children's Hospital
name: Xiangjuan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing Women's and Children's Hospital
name: Lubin Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Le Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: Statistics Department of Peking Union Medical College
name: Tao Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center
name: Joseph Schaffer
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Francis Hospital
name: Marko J Jachtorowycz
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Yuxin Dai
role: STUDY_DIRECTOR
References:
citation: Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
citation: Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
citation: Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
citation: Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.
citation: Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.