Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients

NCT03782285 | Unknown DMC

• 1 other identifier: PekingUnion：SSLF-CSI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally. It is usually accomplished with specially designed equipment in English-language scientific literature. However, these instruments either reusable or disposable are relatively expensive and difficult in accessibility, and are not yet widely applied around China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument.

Conditions

Pelvic Organ Prolapse

Keywords

apical prolapse; sacrospinous Ligament Fixation

Outcome Measures

Primary Outcomes (1)

• Success rate of SSLF with conventional instruments

  1. 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?". 2. The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. 3. There is no need of further treatment for prolapse, such as reoperation or pessary. 4. Pelvic MRI evaluation on postoperative 3 months follow-up

  up to 36 months after operation

Secondary Outcomes (6)

• Postoperative recurrence

  from 3 months after operation up to 36 months after operation

• visual analogue scales

  within 3 days after operation

• symptomatic improvement using validated instruments(PFIQ-7)

  up to 36 months after operation

• symptomatic improvement using validated instruments(PFDI-20)

  up to 36 months after operation

• symptomatic improvement using validated instruments(PISQ-12)

  up to 36 months after operation

Interventions

sacrospinous Ligament Fixation PROCEDURE

sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia.

Also known as: ischial spinous fascia fixation

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with apical prolapse with POP-Q III or IV who are planned to have unilateral SSLF is planned

You may qualify if:

• Women with apical prolapse with POP-Q III or IV
• Unilateral (all sutured to right sacrospinous ligament) SSLF is planned，while with vaginal hysterectomy, anterior/posterior vaginal wall repair 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
• Women who have contraindication for surgical procedure
• Women who are unable to comply with the study procedures

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• First Hospitals affiliated to the China PLA General Hospital: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• Shanxi Provincial Maternity and Children's Hospital: collaborator
• Foshan Women's and Children's Hospital: collaborator
• Suzhou Municipal Hospital: collaborator
• Chongqing Maternal and Child Health Hospital: collaborator
• Hangzhou Maternal and Child Health Hospital: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Peking Union Medical College: collaborator
• St. Francis Hospital, Chicago, USA: collaborator
• University of Texas, Southwestern Medical Center at Dallas: collaborator

Study Sites (9)

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

Chongqing Women's and Children's Hospital

Chongqing, Chongqing Municipality, 400021, China

RECRUITING

Foshan Women's and Children's Hospital

Foshan, Guangdong, 528000, China

RECRUITING

Suzhou City Hospital

Suzhou, Jiangsu, 215008, China

RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shan'xi Province Women's and Children's Hospital

Taiyuan, Shanxi, 300013, China

RECRUITING

Hangzhou Women's and Children's Hospital

Hangzhou, Zhejiang, 310008, China

RECRUITING

Related Publications (3)

• 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: 25724403 RESULT

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

  PMID: 24142057 RESULT

• 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: 28647958 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lan Zhu

  Peking Union Medical College Hospital

  STUDY CHAIR

• 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

• Lubin Liu

  Chongqing Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Xiangjuan Li

  Hangzhou 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

Central Study Contacts

Yuxin Dai, MD

CONTACT

0086-010-69156204; helen81918@163.com

Lan Zhu, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 20, 2018
• Study Start: November 23, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)