Uterine Prolapse Clinical Trial
Official title:
Nationwide Multicenter Randomized Prospective Study to Compare Laparoscopic Sacral Colpopexy and Modified Total Pelvic Floor Reconstructive Surgery With Mesh for Apical Prolapse Stage III-IV
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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