RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
Primary Purpose
Apical Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
native tissue repair procedures with conventional surgical instruments
Sponsored by
About this trial
This is an interventional treatment trial for Apical Prolapse
Eligibility Criteria
Inclusion Criteria:
- Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
- 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.
- Women who have been eligible for long-term follow-up.
- Women who agreed to participate in the study and signed informed consent.
Exclusion Criteria:
- Women who have surgical history for prolapse with mesh.
- Women who have contraindication for surgical procedure
- Women who are unable to comply with the study procedures
Sites / Locations
- 2nd Affiliated hospital of Anhui Medical collegeRecruiting
- 1st Affiliated hospital of PLA general hospitalRecruiting
- Peking Union Medical College HospitalRecruiting
- Suzhou City HospitalRecruiting
- Shanghai First Maternity and Infant HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SSLF-CSI
ISFF-CSI
Arm Description
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)
Outcomes
Primary Outcome Measures
rate of surgical success
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
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
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)
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)
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)
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)
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
using IUGA/ICS joint terminology CTS coding system and dingo system
Full Information
NCT ID
NCT04213027
First Posted
December 25, 2019
Last Updated
December 27, 2019
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04213027
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SSLF-CSI
Arm Type
Active Comparator
Arm Description
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .
Arm Title
ISFF-CSI
Arm Type
Active Comparator
Arm Description
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)
Intervention Type
Procedure
Intervention Name(s)
native tissue repair procedures with conventional surgical instruments
Intervention Description
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).
Primary Outcome Measure Information:
Title
rate of surgical success
Description
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.
Time Frame
up to 36 months after operation
Secondary Outcome Measure Information:
Title
rate of Postoperative recurrence
Description
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.
Time Frame
from 3 months after operation up to 36 months after operation
Title
visual analogue scales
Description
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
Time Frame
up to 36 months after operation, usuallly within 3 days after operation
Title
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)
Description
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.
Time Frame
up to 36 months after operation
Title
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)
Description
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.
Time Frame
up to 36 months after operation
Title
changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)
Description
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.
Time Frame
up to 36 months after operation
Title
results of postoperative symptomatic improvement using patient global impression of change (PGI-C)
Description
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.
Time Frame
up to 36 months after operation
Title
intraoperative and post operative complications
Description
using IUGA/ICS joint terminology CTS coding system and dingo system
Time Frame
up to 36 months after operation
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
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.
Women who have been eligible for long-term follow-up.
Women who agreed to participate in the study and signed informed consent.
Exclusion Criteria:
Women who have surgical history for prolapse with mesh.
Women who have contraindication for surgical procedure
Women who are unable to comply with the study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxin Dai, MD
Phone
0086-010-69156204
Email
helen81918@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Zhu, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongxian Lu
Organizational Affiliation
1st Affiliated hospital of PLA general hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhiyuan Dai
Organizational Affiliation
Shanghai First Maternity and Infant Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenyan Wang
Organizational Affiliation
2nd Affiliated hospital of Anhui Medical college
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhaoai Li
Organizational Affiliation
Shan'xi Province Women's and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuling Wang
Organizational Affiliation
Foshan Women's and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shunyu Hou
Organizational Affiliation
Suzhou City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiangjuan Li
Organizational Affiliation
Hangzhou Women's and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lubin Liu
Organizational Affiliation
Chongqing Women's and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Le Ma
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tao Xu
Organizational Affiliation
Statistics Department of Peking Union Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Schaffer
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marko J Jachtorowycz
Organizational Affiliation
Saint Francis Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lan Zhu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuxin Dai
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
2nd Affiliated hospital of Anhui Medical college
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyan Wang
Facility Name
1st Affiliated hospital of PLA general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongxian Lu
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxin Dai, MD
Phone
0086-010-69156204
Email
helen81918@163.com
First Name & Middle Initial & Last Name & Degree
Lan Zhu
Facility Name
Suzhou City Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunyu Hou
Facility Name
Shanghai First Maternity and Infant Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyuan Dai
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23633316
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.
Results Reference
background
PubMed Identifier
24142057
Citation
Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
Results Reference
background
PubMed Identifier
21060988
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.
Results Reference
background
PubMed Identifier
28647958
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.
Results Reference
background
PubMed Identifier
25724403
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.
Results Reference
result
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RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
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