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RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients

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ClinicalTrials.gov Identifier: NCT04213027
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
zhulan, Peking Union Medical College Hospital

Study Description
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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
Apical Prolapse Procedure: native tissue repair procedures with conventional surgical instruments Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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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
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Primary Outcome Measures :
  1. rate of surgical success [ Time Frame: 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 :
  1. rate of Postoperative recurrence [ Time Frame: 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.


  2. visual analogue scales [ Time Frame: 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

  3. changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7) [ Time Frame: 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.

  4. changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20) [ Time Frame: 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.

  5. changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12) [ Time Frame: 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.

  6. results of postoperative symptomatic improvement using patient global impression of change (PGI-C) [ Time Frame: 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.

  7. intraoperative and post operative complications [ Time Frame: up to 36 months after operation ]
    using IUGA/ICS joint terminology CTS coding system and dingo system


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213027


Contacts
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Contact: Yuxin Dai, MD 0086-010-69156204 helen81918@163.com
Contact: Lan Zhu, MD

Locations
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China, Anhui
2nd Affiliated hospital of Anhui Medical college Recruiting
Hefei, Anhui, China, 230041
Contact: Wenyan Wang         
China, Beijing
1st Affiliated hospital of PLA general hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Yongxian Lu         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yuxin Dai, MD    0086-010-69156204    helen81918@163.com   
Contact: Lan Zhu         
China, Jiangsu
Suzhou City Hospital Recruiting
Suzhou, Jiangsu, China, 215008
Contact: Shunyu Hou         
China, Shanghai
Shanghai First Maternity and Infant Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Zhiyuan Dai         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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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
More Information
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Publications of Results:

Other Publications:

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Responsible Party: zhulan, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04213027    
Other Study ID Numbers: PekingUMCH SSLFvsISFF-CSI
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical