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Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique

Primary Purpose

Prolapse Uterovaginal, Prolapse Bladder, Laparoscopy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laparoscopic Meshless Sacrocolpopexy Technique
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse Uterovaginal focused on measuring Laparoscopy, Pelvic Organ Prolapse

Eligibility Criteria

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

Inclusion Criteria:

  • Female patients older than 30 years and younger than 80 years old
  • Patients who provided written consent for this surgical procedure

Exclusion Criteria:

  • Patients who cannot obtain anesthesia approval for laparoscopic surgery
  • Patients with asymptomatic pelvic organ prolapse
  • Patients with active pelvic inflammatory disease
  • Patients who have a confirmed or suspected pregnancy or malignancy
  • Patients who have an unexplored abnormal cervical-uterine cytology

Sites / Locations

  • Zeynep Kamil Maternity and Childrens Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meshless Approach

Arm Description

Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse.

Outcomes

Primary Outcome Measures

Visual analog Scale
Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.
POP-Q classification
examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.
PQOL
Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.
FSFI
Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.
Urinary Incontinance
Questioning and examining patient after surgery related to urinary incontinancy complaint, and evaluating the incontinancy state with questionnaires of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6)

Secondary Outcome Measures

Full Information

First Posted
September 25, 2022
Last Updated
September 28, 2022
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05558852
Brief Title
Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique
Official Title
Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mesh is widely applied in the abdominal approach to pelvic organ prolapse surgery, and sacrocolpopexy-sacrohysteropexy is the gold standard application, particularly for central compartment abnormalities. There are numerous disadvantages associated with the use of mesh. In some studies, the rate of mesh complications (such as mesh erosion, contraction, response, and pain) can reach 20%. This surgical approach aims to provide laparoscopic repair of pelvic organ prolapse without the use of mesh, hence avoiding the difficulties associated with mesh.
Detailed Description
Patients who present to the Zeynep Kamil Education and Research Hospital Gynecology and Obstetrics Clinic between July 2022 and April 2023 with the complaint of prolapse and have uterine or vaginal cuff prolapse due to a central defect or cystocele due to an anterior compartment defect and are indicated for surgery will be included in the study.The surgeries will be performed laparoscopically after obtaining their written consent. The Technique; The anterior promontory and the presacral area are dissected to expose the anterior longitudinal ligament. Dissection from this region, extension of the right sacrouter ligament from the lateral to the vaginal cuff or retrocervical region as well as visualization of the right ureter, isolation of the right sacrouterine ligament. Dissection of the vesicovaginal space by cutting the vesicouterine peritoneum and eradication of the bladder. Lower limit of anterior compartment dissection; Exposing the puboservicovaginal fascia sufficiently to repair the anterior defect and exposing the defect. Dissection of the Yabuki space to control the entrance of the ureters into the bladder during anterior compartment dissection. Performing a hysterectomy and suturing the vaginal cup if additional gynecological indications are present. (in women with a uterus). Repairing the defective pubocervico-vaginal fascia using 2.0 prolene for an anterior compartment defect and suturing this fascia to the cervical ring or sacrouterine ligaments in the vaginal cuff using 2.0 prolene. Attaining the sacral promontory with two strong sutures starting from the vaginal cuff or cervix using 1.0 prolene and continuous circular sutures along the right sacrouterine ligament while using the same suture. After passing 1 strong suture through the anterior longitudinal ligament, the same suture will be continued along the right sacrouterine ligament in a continuous and circular manner. Knotting where the suture begins to create sufficient tension (maintaining the vaginal cuff level at -2) (The sacrocolpopexy technique: transforming the sacrouterine ligament into a rope with an insoluble suture material). Finally, providing peritonization with 2.0 vicryl and, if indicated, culdoplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse Uterovaginal, Prolapse Bladder, Laparoscopy
Keywords
Laparoscopy, Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Anticipated 25 patients will be evaluated and operated with meshless method.
Masking
None (Open Label)
Masking Description
Only one attending surgeon will operate the all participants. The patients will be evaluated pre-operatively by the surgeon and postoperatively 6th months by a different physician ( who is practicing as a gynecologist in the same hospital).
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meshless Approach
Arm Type
Experimental
Arm Description
Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Meshless Sacrocolpopexy Technique
Intervention Description
Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse
Primary Outcome Measure Information:
Title
Visual analog Scale
Description
Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.
Time Frame
6 months after the operation
Title
POP-Q classification
Description
examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.
Time Frame
6 months after the operation
Title
PQOL
Description
Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.
Time Frame
6 months after the operation
Title
FSFI
Description
Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.
Time Frame
6 months after the operation
Title
Urinary Incontinance
Description
Questioning and examining patient after surgery related to urinary incontinancy complaint, and evaluating the incontinancy state with questionnaires of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6)
Time Frame
6 months after the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients in between 30 to 80 years old with a symptomatic vaginal cuff/uterine prolapse and/or cyctocele
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patients older than 30 years and younger than 80 years old Patients who provided written consent for this surgical procedure Exclusion Criteria: Patients who cannot obtain anesthesia approval for laparoscopic surgery Patients with asymptomatic pelvic organ prolapse Patients with active pelvic inflammatory disease Patients who have a confirmed or suspected pregnancy or malignancy Patients who have an unexplored abnormal cervical-uterine cytology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Resul Karakus, MD
Phone
05059164216
Email
resul-karakus@hotmail.com
Facility Information:
Facility Name
Zeynep Kamil Maternity and Childrens Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34660
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Resul Karakus, MD
Phone
+905059164216
Email
resul-karakus@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique

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