Clinical trial NCT01762384: Laparoscopic Sacral Colpopexy Versus Modified Total Pelvic Floor Reconstructive Surgery for Apical Prolapse Stage III-IV
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Prolapse
Vault Prolapse
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: anatomical improvement according to POP-Q score
timeFrame: 6 months
measure: Anatomical improvement according to POP-Q Score
timeFrame: 1 year
measure: Anatomical improvement according to POP-Q Score
timeFrame: 2 years
measure: Anatomical improvement according to POP-Q Score
timeFrame: 3 years
Secondary outcomes:
measure: Hospital data:operative time
timeFrame: At discharge, an expected average of 5 days after operation.
measure: Presence/absence of complications (composite score).
timeFrame: up to 6 weeks
measure: Change from baseline in PFIQ-7 scores.
timeFrame: 6 months, 1 year, 2 year, 3 year
measure: Change from baseline in PFDI-21 scores.
timeFrame: 6 months, 1 year, 2 year, 3 year
measure: In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)
timeFrame: 6 months, 1 year, 2 year, 3 year
measure: Subject global impression assessed on a 5 point Likert scale
timeFrame: 6 months, 1 year, 2 year, 3 year
measure: Presence/absence of complications (composite score)
timeFrame: up to 3 years
measure: hospital data: estimated blood loss
timeFrame: At discharge, an expected average of 5 days after operation.
measure: hospital data:length of stay
timeFrame: At discharge, an expected average of 5 days after operation.
measure: hospital data: postoperative morbidity
timeFrame: At discharge, an expected average of 5 days after operation.
measure: hospital data: time to recovery
timeFrame: At discharge, an expected average of 5 days after operation.
Other outcomes:
Locations:
city: Ghuangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: