Status:
UNKNOWN
Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
First Hospitals affiliated to the China PLA General Hospital
Shanghai First Maternity and Infant Hospital
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
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 Englis...
Detailed Description
Apical prolapse is defined as descent of the uterus and cervix, the cervix alone, or the post-hysterectomy vaginal cuff down to the hymen, lower vagina, or past the introitus. Among 684,250 POP proced...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Women who have surgical history for prolapse
- Women who have contraindication for surgical procedure
- Women who are unable to comply with the study procedures
Key Trial Info
Start Date :
November 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03782285
Start Date
November 23 2018
End Date
September 1 2019
Last Update
December 20 2018
Active Locations (9)
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1
2nd Affiliated hospital of Anhui Medical college
Hefei, Anhui, China, 230041
2
1st Affiliated hospital of PLA general hospital
Beijing, Beijing Municipality, China, 100037
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
Chongqing Women's and Children's Hospital
Chongqing, Chongqing Municipality, China, 400021