RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: SSLF-CSI native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) . |
Procedure: native tissue repair procedures with conventional surgical instruments
Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
|
| Active Comparator: ISFF-CSI native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF) |
Procedure: native tissue repair procedures with conventional surgical instruments
Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
|
Outcome Measures
Primary Outcome Measures
- rate of surgical success [up to 36 months after operation]
definition for surgical success is symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. There is no need of further treatment for prolapse, such as reoperation or pessary.
Secondary Outcome Measures
- rate of Postoperative recurrence [from 3 months after operation up to 36 months after operation]
definition for postoperative recurrence is symptomatic prolapse above grade II occurred 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. Vaginal swelling sensation, that is answer "yes" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". There is need of further treatment for prolapse, such as reoperation or pessary.
- visual analogue scales [up to 36 months after operation, usuallly within 3 days after operation]
postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain). VAS result will be reported ranging from 0 to 10, with 0 representing no pain, and 10 representing unbearable severe pain
- changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7) [up to 36 months after operation]
Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
- changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20) [up to 36 months after operation]
Relief of symptoms using validated instruments, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.
- changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12) [up to 36 months after operation]
Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
- results of postoperative symptomatic improvement using patient global impression of change (PGI-C) [up to 36 months after operation]
Relief of symptoms using patient global impression of change (PGI-C)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.
- intraoperative and post operative complications [up to 36 months after operation]
using IUGA/ICS joint terminology CTS coding system and dingo system
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
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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.
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Women who have been eligible for long-term follow-up.
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Women who agreed to participate in the study and signed informed consent.
Exclusion Criteria:
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Women who have surgical history for prolapse with mesh.
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Women who have contraindication for surgical procedure
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Women who are unable to comply with the study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Affiliated hospital of Anhui Medical college | Hefei | Anhui | China | 230041 |
| 2 | 1st Affiliated hospital of PLA general hospital | Beijing | Beijing | China | 100037 |
| 3 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
| 4 | Suzhou City Hospital | Suzhou | Jiangsu | China | 215008 |
| 5 | Shanghai First Maternity and Infant Hospital | Shanghai | Shanghai | China | 200040 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Yongxian Lu, 1st Affiliated hospital of PLA general hospital
- Principal Investigator: Zhiyuan Dai, Shanghai First Maternity and Infant Hospital
- Principal Investigator: Wenyan Wang, 2nd Affiliated hospital of Anhui Medical college
- Principal Investigator: Zhaoai Li, Shan'xi Province Women's and Children's Hospital
- Principal Investigator: Yuling Wang, Foshan Women's and Children's Hospital
- Principal Investigator: Shunyu Hou, Suzhou City Hospital
- Principal Investigator: Xiangjuan Li, Hangzhou Women's and Children's Hospital
- Principal Investigator: Lubin Liu, Chongqing Women's and Children's Hospital
- Principal Investigator: Le Ma, Beijing Obstetrics and Gynecology Hospital
- Principal Investigator: Tao Xu, Statistics Department of Peking Union Medical College
- Principal Investigator: Joseph Schaffer, UT Southwestern Medical Center
- Principal Investigator: Marko J Jachtorowycz, Saint Francis Memorial Hospital
- Study Chair: Lan Zhu, Peking Union Medical College Hospital
- Study Director: Yuxin Dai, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1. Review.
- 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. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014.
- 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.
- 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.
- PekingUMCH SSLFvsISFF-CSI