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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01762384
First received: December 30, 2012
Last updated: January 4, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Uterine Prolapse
Vault Prolapse
Procedure: LSC
Procedure: modified PFRS
Device: "Gynemesh"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • anatomical improvement according to POP-Q score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital data:operative time [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications (composite score). [ Time Frame: up to 6 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Change from baseline in PFIQ-7 scores. [ Time Frame: 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Change from baseline in PFDI-21 scores. [ Time Frame: 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) [ Time Frame: 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Subject global impression assessed on a 5 point Likert scale [ Time Frame: 6 months, 1 year, 2 year, 3 year ] [ Designated as safety issue: No ]
  • Presence/absence of complications (composite score) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    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.

  • hospital data: estimated blood loss [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]
  • hospital data:length of stay [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]
  • hospital data: postoperative morbidity [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]
  • hospital data: time to recovery [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LSC
procedure: laparoscopic sacral colpopexy.
Procedure: LSC
subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.
Device: "Gynemesh"
Both surgeries will be conducted using mesh constructed from polypropylene mesh.
Active Comparator: Modified PFRS
procedure: modified pelvic floor reconstructive surgery with mesh.
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.

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

Ages Eligible for Study:   55 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762384

Contacts
Contact: Lan Zhu 86-13911714696 zhu_julie@sina.com
Contact: Juan Chen 86-13521354364 pumchcj@sina.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College Recruiting
Ghuangzhou, Guangdong, China, 510120
Contact: Xiaowei Zhang    86-13609086710    xwzhang81341235@163.com   
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mei Ji       jimei0821@yahoo.com.cn   
China, Zhejiang
Women's Hospital School of Medicine Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Hangmei Jin       jinhm@zju.edu.cn   
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Lan Zhu    86-13911714696      
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01762384     History of Changes
Other Study ID Numbers: pumch-gyn-05
Study First Received: December 30, 2012
Last Updated: January 4, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on August 28, 2014