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Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV

NCT01762384 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Uterine Prolapse
  • Vault Prolapse

Interventions

PROCEDURE

LSC

subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.

PROCEDURE

modified PFRS

subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh.

DEVICE

"Gynemesh"

Both surgeries will be conducted using mesh constructed from polypropylene mesh.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Lan Zhu · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762384 on ClinicalTrials.gov