Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III
|ClinicalTrials.gov Identifier: NCT01670682|
Recruitment Status : Unknown
Verified August 2012 by gwcmc.
Recruitment status was: Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure and modified total pelvic floor reconstructive surgery with mesh are both developed in China for vaginal apex fixation, the former is native tissue repairs, and the latter is augmentation with mesh.
This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure compared with modified total pelvic floor reconstructive surgery with mesh for the treatment of pelvic organ prolapse stage III.
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.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Procedure: ischia spinous fascia fixation Procedure: Modified Pelvic Floor Reconstruction Surgery with Mesh Device: polypropylene mesh(Gynemesh)||Not Applicable|
Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.
Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia fixation procedure with native tissue and modified total pelvic floor reconstructive surgery with mesh. They are both developed and popular in China. Clinical practice showed that they were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year follow-up were about 10%, and quality of life improved significantly from the baseline, while the.complications are different.
The purpose of this multicenter, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ prolapse Stage III in China.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective，Multicenter Pilot Study to Compare Ischia Spinous Fascia Fixation Procedure With Modified Total Pelvic Floor Reconstruction Surgery For Pelvic Organ Prolapse Stage III|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Active Comparator: fascia fixation group
procedure: ischia spinous fascia fixation
Procedure: ischia spinous fascia fixation
Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
Active Comparator: mesh group
Procedure: Modified Pelvic Floor Reconstruction Surgery with mesh
Procedure: Modified Pelvic Floor Reconstruction Surgery with Mesh
Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
Device: polypropylene mesh(Gynemesh)
Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
- •Anatomical improvement according to POP-Q score. [ Time Frame: 6 weeks ]
- •Anatomical improvement according to POP-Q score. [ Time Frame: 1 year ]
- •Anatomical improvement according to POP-Q score. [ Time Frame: 2 years ]
- •Anatomical improvement according to POP-Q score. [ Time Frame: 3 years ]
- •Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery. [ Time Frame: At discharge, an expected average of 5 days after operation. ]
- •Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 6-week visit ]
- •Presence/absence of complications (composite score). [ Time Frame: Up to 6 weeks. ]The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale.
- •Change from baseline in PFIQ-7 scores. [ Time Frame: 1 year, 2 years and 3 years. ]
- •In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) [ Time Frame: 1 year, 2 years and 3 years. ]
- •Subject global impression assessed on a 5 point Likert scale [ Time Frame: 1 year, 2 years and 3 years. ]
- •Presence/absence of complications (composite score) [ Time Frame: Up to 3 years. ]Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, mesh erosion, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670682
|Foshan Maternal and Child Health Hospital||Recruiting|
|Foshan, Guangdong, China, 528000|
|Contact: Yuling Wang 13049161630 Wujun701121@126.com|
|Peking University Shenzhen Hospital||Recruiting|
|Shenzhen, Guangdong, China, 518036|
|Contact: Huan Li 13828700921 firstname.lastname@example.org|
|the Third Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Luwen Wang 13607683293 Wangluwen_688@sohu.com|
|Affiliated Shengjing Hospital of China Medical University||Recruiting|
|Shenyang, Liaoning, China, 110004|
|Contact: Zhijun Xia 13840118800 email@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Juan Chen 13521354364 firstname.lastname@example.org|