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

Primary Purpose

Uterine Prolapse, Vault Prolapse

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

LSC

modified PFRS

"Gynemesh"

About this trial

This is an interventional treatment trial for Uterine Prolapse

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

The First Affiliated Hospital of Guangzhou Medical CollegeRecruiting
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Women's Hospital School of Medicine Zhejiang UniversityRecruiting
Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

LSC

Modified PFRS

Arm Description

procedure: laparoscopic sacral colpopexy.

procedure: modified pelvic floor reconstructive surgery with mesh.

Outcomes

Primary Outcome Measures

anatomical improvement according to POP-Q score

Anatomical improvement according to POP-Q Score

Secondary Outcome Measures

Hospital data:operative time

Presence/absence of complications (composite score).

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.

Change from baseline in PFDI-21 scores.

In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline)

Subject global impression assessed on a 5 point Likert scale

Presence/absence of complications (composite score)

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

hospital data:length of stay

hospital data: postoperative morbidity

hospital data: time to recovery

Full Information

NCT ID

NCT01762384

First Posted

December 30, 2012

Last Updated

January 4, 2013

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01762384

Brief Title

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

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Prolapse, Vault Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LSC

Arm Type

Active Comparator

Arm Description

procedure: laparoscopic sacral colpopexy.

Arm Title

Modified PFRS

Arm Type

Active Comparator

Arm Description

procedure: modified pelvic floor reconstructive surgery with mesh.

Intervention Type

Procedure

Intervention Name(s)

LSC

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

modified PFRS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

"Gynemesh"

Intervention Description

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

Primary Outcome Measure Information:

Title

anatomical improvement according to POP-Q score

Time Frame

6 months

Title

Anatomical improvement according to POP-Q Score

Time Frame

1 year

Title

Anatomical improvement according to POP-Q Score

Time Frame

2 years

Title

Anatomical improvement according to POP-Q Score

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Hospital data:operative time

Time Frame

At discharge, an expected average of 5 days after operation.

Title

Presence/absence of complications (composite score).

Description

Time Frame

up to 6 weeks

Title

Change from baseline in PFIQ-7 scores.

Time Frame

6 months, 1 year, 2 year, 3 year

Title

Change from baseline in PFDI-21 scores.

Time Frame

6 months, 1 year, 2 year, 3 year

Title

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

Title

Subject global impression assessed on a 5 point Likert scale

Time Frame

6 months, 1 year, 2 year, 3 year

Title

Presence/absence of complications (composite score)

Description

Time Frame

up to 3 years

Title

hospital data: estimated blood loss

Time Frame

At discharge, an expected average of 5 days after operation.

Title

hospital data:length of stay

Time Frame

At discharge, an expected average of 5 days after operation.

Title

hospital data: postoperative morbidity

Time Frame

At discharge, an expected average of 5 days after operation.

Title

hospital data: time to recovery

Time Frame

At discharge, an expected average of 5 days after operation.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lan Zhu

Phone

86-13911714696

zhu_julie@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Chen

Phone

86-13521354364

pumchcj@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lan Zhu

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Guangzhou Medical College

City

Ghuangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaowei Zhang

Phone

86-13609086710

xwzhang81341235@163.com

Facility Name

The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mei Ji

jimei0821@yahoo.com.cn

Facility Name

Women's Hospital School of Medicine Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hangmei Jin

jinhm@zju.edu.cn

Facility Name

Peking Union Medical College Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lan Zhu

Phone

86-13911714696

12. IPD Sharing Statement

Learn more about this trial

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

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