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

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

Interventions

PROCEDURE

sacrospinous Ligament Fixation

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.

Sponsors & Collaborators

• First Hospitals affiliated to the China PLA General Hospital

  collaborator OTHER_GOV

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Foshan Women's and Children's Hospital

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Chongqing Maternal and Child Health Hospital

  collaborator OTHER

• Hangzhou Maternal and Child Health Hospital

  collaborator UNKNOWN

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Peking Union Medical College

  collaborator OTHER

• St. Francis Hospital, Chicago, USA

  collaborator UNKNOWN

• University of Texas, Southwestern Medical Center at Dallas

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Lan Zhu · Peking Union Medical College Hospital

• Yongxian Lu · 1st Affiliated hospital of PLA general hospital

• Zhiyuan Dai · Shanghai First Maternity and Infant Hospital

• Wenyan Wang · 2nd Affiliated hospital of Anhui Medical college

• Zhaoai Li · Shan'xi Province Women's and Children's Hospital

• Yuling Wang · Foshan Women's and Children's Hospital

• Shunyu Hou · Suzhou City Hospital

• Lubin Liu · Chongqing Women's and Children's Hospital

• Xiangjuan Li · Hangzhou Women's and Children's Hospital

• Le Ma · Beijing Obstetrics and Gynecology Hospital

• Tao Xu · Statistics Department of Peking Union Medical College

• Joseph Schaffer · UT Southwestern Medical Center

• Marko J Jachtorowycz · Saint Francis Hospital

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-23

Primary Completion

2019-08-31

Completion

2019-09-30

Countries

• China

Study Locations