NCT04213027

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

December 25, 2019

Last Update Submit

December 27, 2019

Conditions

Apical Prolapse

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 36 months after operation

Secondary Outcomes (7)

  • rate of Postoperative recurrence

    from 3 months after operation up to 36 months after operation

  • visual analogue scales

    up to 36 months after operation, usuallly within 3 days after operation

  • changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)

    up to 36 months after operation

  • changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)

    up to 36 months after operation

  • changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)

    up to 36 months after operation

  • +2 more secondary outcomes

Study Arms (2)

SSLF-CSI

ACTIVE COMPARATOR

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

ISFF-CSI

ACTIVE COMPARATOR

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

Interventions

native tissue repair procedures with conventional surgical instrumentsPROCEDURE

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).

ISFF-CSISSLF-CSI

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

2nd Affiliated hospital of Anhui Medical college

Hefei, Anhui, 230041, China

RECRUITING

1st Affiliated hospital of PLA general hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Suzhou City Hospital

Suzhou, Jiangsu, 215008, China

RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23633316BACKGROUND

  • Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.

    PMID: 24142057BACKGROUND

  • 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.

    PMID: 21060988BACKGROUND

  • 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.

    PMID: 28647958BACKGROUND

  • 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.

    PMID: 25724403RESULT

Study Officials

  • 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

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

  • Marko J Jachtorowycz

    Saint Francis Hospital

    PRINCIPAL INVESTIGATOR

  • Lan Zhu

    Peking Union Medical College Hospital

    STUDY CHAIR

  • Yuxin Dai

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Yuxin Dai, MD

CONTACT

0086-010-69156204helen81918@163.com

Lan Zhu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)