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Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

Primary Purpose

Pelvic Organ Prolapse, Surgical Procedure, Unspecified

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Apical prolapse fixation - anterior access
Apical prolapse fixation - posterior access
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse.
  • Women who suffer from symptomatic POP and care for a surgical treatment

Exclusion Criteria:

  • Women with a contra-indication for surgical treatment

Sites / Locations

  • Haemek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

anterior approach for apical fixation to the SSL

posterior approach for apical fixation to the SSL

Arm Description

In this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall.

In this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall.

Outcomes

Primary Outcome Measures

Compound cure rate
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 6-month follow-up (and will be further followed yearly until 2 years of total follow up): A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment

Secondary Outcome Measures

Duration of surgery
Duration of surgery in minutes
Change in hemoglobin level from pre-operation level to post-operative level in g/dl units
to assess the difference in Hb level before and after the surgery
Intraoperative complications
Any documented event of perforation of adjacent organs such as bladder, ureter, intestine or blood vessel injury that occured during the surgery
Peri-operative complications
Any event of fever / abnormal discharge / abscess / contaminated hematoma/ need for blood transfusion
Maximal pain score
To assess a patient's pain level, the investigators will use visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). the investigators will assess the maximum pain level during the 6 weeks after the surgery
Change in PFDI-20 score
Mean scores and change from baseline of PFDI-20 score at 6 and 12, 24 months. To evaluate prolapse, urinary and bowel function(PFDI-20).
Patient global impression of improvement from surgery
Mean scores of PGI-I at 6 and 12, 24 months. To evaluate patient satisfaction from the surgery.
Cure rate at 12 months post-operation
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 12-month follow-up : A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment
Cure rate at 24 months post-operation
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 24-month follow-up : A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment
long term complications
Incidence of new-onset dyspareunia; de-novo urinary or bowel problems; re-operation for prolapse in the index compartment; de-novo pelvic pain.

Full Information

First Posted
February 24, 2020
Last Updated
November 30, 2022
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT04306250
Brief Title
Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
Official Title
Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%. The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall. A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length. From the literature review to date, no comparisons were made between the methods in a randomized controlled trial. Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF
Detailed Description
Pelvic organ prolapse (POP) is a common problem among women and its incidence is rising due to population aging. Approximately 11-19% of women will undergo surgery for pelvic organ prolapse (POP) or urinary incontinence during their lifetime and approximately 30% will need repeat surgery during their lifetime .Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. The severity of the prolapsed organ can be graded according to the POP-Q classification .There are several approaches to apical fixation, some of which are done vaginally and include fixation by sutures to the uterosacral ligament (USLF) or the sacrospinous ligament (SSLF). A mesh can be used for ligament fixation as well. The abdominal approach is also an option, the sacro-colpo-pexy fixation using a Y mesh. Apical fixation to the SSL was first introduced in 1968 by K.RICHTER. medical devices such as the Capio that assist in performing SSLF were also developed with ease. In a review article that included 2,390 women undergoing SSLF subjective cure rate ranged from 70 to 98%, while objective cure rate was 67-97% .Such fixation in combination with posterior or anterior wall repair, especially after hysterectomy, showed a 94% objective cure rate at 7-year postoperative follow-up. A randomized study (The "OPTIMAL randomised trial") comparing SSLF with USLF found no preference for either method. Success rates were measured according to three criteria - 1) no significant vaginal dome or one of the vaginal walls 2) no vaginal bulge symptoms 3) no need for repeated surgery within two years of the original surgery. According to this study, the success rates of SSLF after two years were 63.1%. Among women with anterior vaginal wall prolapse and AP, SSLF can be performed in two ways: anterior access, ie dissection through the anterior wall of the vagina or fixation through the posterior wall of the vagina. A retrospective comparison of the two methods was performed, demonstrating some efficacy in anterior approach in terms of vaginal length and postoperative apical fixation with less reference to healing rates or impact on the anterior compartment, compared with a posterior approach. From the literature review to date, no comparisons were made between the methods in a randomized controlled trial. Objective: To compare the success rates of two approaches (anterior and posterior) for SSLF

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Surgical Procedure, Unspecified

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anterior approach for apical fixation to the SSL
Arm Type
Experimental
Arm Description
In this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall.
Arm Title
posterior approach for apical fixation to the SSL
Arm Type
Active Comparator
Arm Description
In this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall.
Intervention Type
Procedure
Intervention Name(s)
Apical prolapse fixation - anterior access
Intervention Description
The surgery is done in anterior access
Intervention Type
Procedure
Intervention Name(s)
Apical prolapse fixation - posterior access
Intervention Description
The surgery is done in posterior access
Primary Outcome Measure Information:
Title
Compound cure rate
Description
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 6-month follow-up (and will be further followed yearly until 2 years of total follow up): A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment
Time Frame
6-month (and will be further followed yearly until 2 years of total follow up)
Secondary Outcome Measure Information:
Title
Duration of surgery
Description
Duration of surgery in minutes
Time Frame
From the time of the first cut of the surgery to the time the surgery ends (as documented in the surgery report), up to 240 minutes
Title
Change in hemoglobin level from pre-operation level to post-operative level in g/dl units
Description
to assess the difference in Hb level before and after the surgery
Time Frame
Hb level will be measured up to 1 month before the surgery and at the 24 hours after surgery. Further examinations will be taken if there is clinical suspicious for bleeding, up to the day of discharge)
Title
Intraoperative complications
Description
Any documented event of perforation of adjacent organs such as bladder, ureter, intestine or blood vessel injury that occured during the surgery
Time Frame
Any complication the occured during the duration of the surgery
Title
Peri-operative complications
Description
Any event of fever / abnormal discharge / abscess / contaminated hematoma/ need for blood transfusion
Time Frame
Any complications that occured from the end of the surgery until the first check-up visit (6 weeks after rthe surgery)
Title
Maximal pain score
Description
To assess a patient's pain level, the investigators will use visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). the investigators will assess the maximum pain level during the 6 weeks after the surgery
Time Frame
Maximal pain level during the 6 weeks after the surgery
Title
Change in PFDI-20 score
Description
Mean scores and change from baseline of PFDI-20 score at 6 and 12, 24 months. To evaluate prolapse, urinary and bowel function(PFDI-20).
Time Frame
6, 12 and 24 months post the operation
Title
Patient global impression of improvement from surgery
Description
Mean scores of PGI-I at 6 and 12, 24 months. To evaluate patient satisfaction from the surgery.
Time Frame
6, 12 and 24 months post the operation
Title
Cure rate at 12 months post-operation
Description
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 12-month follow-up : A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment
Time Frame
12 months post the operation
Title
Cure rate at 24 months post-operation
Description
A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 24-month follow-up : A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score <2). c. No re-treatment (surgical/ non-surgical) for index compartment
Time Frame
24 months post the operation
Title
long term complications
Description
Incidence of new-onset dyspareunia; de-novo urinary or bowel problems; re-operation for prolapse in the index compartment; de-novo pelvic pain.
Time Frame
6, 12 and 24 months post the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse. Women who suffer from symptomatic POP and care for a surgical treatment Exclusion Criteria: Women with a contra-indication for surgical treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
meirav breverman, MD
Phone
97246495507
Email
meirav_al@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
eyal rom, MD
Phone
97246495507
Email
eyalro@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
meirav breverman, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meirav Breverman, MD
Email
meirav_al@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Sivan Witzman
Phone
972-4-6495348
Email
sivan_we@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

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