Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV
NCT ID: NCT01762384
Last Updated: 2013-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2012-12-31
2017-12-31
Brief Summary
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This study is designed to determine the effectiveness and safety of Modified total pelvic floor reconstructive surgery with mesh compared with laparoscopic Sacral Colpopexy for the treatment of uterine or vault prolapse Stage III-IV.
Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.
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Detailed Description
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Sacral colpopexy has long been regarded as the gold standard. Laparoscopic sacral colpopexy could offer durable result and low morbidity compared with open procedure.
In clinical practice, many women have symptomatic POP-Q Stage III-IV uterine or vault prolapse, which requires surgical correction. The aim of this multicenter, prospective and randomized study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic apical prolapse Stage III-IV in China.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LSC
procedure: laparoscopic sacral colpopexy.
LSC
subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.
"Gynemesh"
Both surgeries will be conducted using mesh constructed from polypropylene mesh.
Modified PFRS
procedure: modified pelvic floor reconstructive surgery with mesh.
modified PFRS
subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh.
"Gynemesh"
Both surgeries will be conducted using mesh constructed from polypropylene mesh.
Interventions
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LSC
subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.
modified PFRS
subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh.
"Gynemesh"
Both surgeries will be conducted using mesh constructed from polypropylene mesh.
Eligibility Criteria
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Inclusion Criteria
* Age from 55-65 years old.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.
Exclusion Criteria
* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy. Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* Chronic cough not well-controlled.
* BMI ≥ 30.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
55 Years
65 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan Zhu
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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The First Affiliated Hospital of Guangzhou Medical College
Ghuangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Lan Zhu
Role: primary
Other Identifiers
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pumch-gyn-05
Identifier Type: -
Identifier Source: org_study_id
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