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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Uterine Prolapse; Vault Prolapse

Treatments: Device: "Gynemesh"; Procedure: LSC; Procedure: modified PFRS

Study type: Interventional

Funder types: Other

Identifiers

NCT01762384

pumch-gyn-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidates with symptomatic uterine or vault prolapse of Stage III-IV, suitable for surgical repair.
• Age from 55-65 years old.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.

Exclusion criteria

• Patients who could not tolerate laparoscopic surgery.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

LSC

Active Comparator group

Description:

procedure: laparoscopic sacral colpopexy.

Treatment:

Device: "Gynemesh"

Procedure: LSC

Modified PFRS

Active Comparator group

Description:

procedure: modified pelvic floor reconstructive surgery with mesh.

Treatment:

Device: "Gynemesh"

Procedure: modified PFRS