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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. The primary treatment is surgery. Sacral Colpopexy is the gold standard procedure. Now it could be done laparoscopically. Modified total pelvic floor reconstructive surgery with mesh is developed in China for Asian Women.
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.
Pelvic organ prolapse is a common problem. The high rate of failure has led to an increasing use of synthetic grafts to augment vaginal repair procedures to obtain more durable results. In 2005, the investigators began to perform modified pelvic floor reconstruction surgery with mesh. The nation-wide multicenter prospective clinical trial data showed that it was safe, efficient and cost-effective. No severe intraoperative complications were recorded and the recurrence rate after 1 year follow-up was 8.1%. Quality of life improved significantly from the baseline, while the sexual function did not change.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSC | Active Comparator | procedure: laparoscopic sacral colpopexy. |
|
| Modified PFRS | Active Comparator | procedure: modified pelvic floor reconstructive surgery with mesh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LSC | Procedure | subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| anatomical improvement according to POP-Q score | 6 months | |
| Anatomical improvement according to POP-Q Score | 1 year | |
| Anatomical improvement according to POP-Q Score | 2 years | |
| Anatomical improvement according to POP-Q Score | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital data:operative time | At discharge, an expected average of 5 days after operation. | |
| Presence/absence of complications (composite score). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 86-13911714696 | zhu_julie@sina.com | |
| Juan Chen | Contact | 86-13521354364 | pumchcj@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical College | Recruiting | Ghuangzhou | Guangdong | 510120 | China |
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| modified PFRS | Procedure | subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh. |
|
| "Gynemesh" | Device | Both surgeries will be conducted using mesh constructed from polypropylene mesh. |
|
| up to 6 weeks |
| Change from baseline in PFIQ-7 scores. | 6 months, 1 year, 2 year, 3 year |
| Change from baseline in PFDI-21 scores. | 6 months, 1 year, 2 year, 3 year |
| In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) | 6 months, 1 year, 2 year, 3 year |
| Subject global impression assessed on a 5 point Likert scale | 6 months, 1 year, 2 year, 3 year |
| Presence/absence of complications (composite score) | 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. | up to 3 years |
| hospital data: estimated blood loss | At discharge, an expected average of 5 days after operation. |
| hospital data:length of stay | At discharge, an expected average of 5 days after operation. |
| hospital data: postoperative morbidity | At discharge, an expected average of 5 days after operation. |
| hospital data: time to recovery | At discharge, an expected average of 5 days after operation. |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Women's Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
|
| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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