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

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ClinicalTrials.gov Identifier: NCT05558852
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prolapse Uterovaginal Prolapse Bladder Laparoscopy Procedure: Laparoscopic Meshless Sacrocolpopexy Technique Not Applicable

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;

  1. The anterior promontory and the presacral area are dissected to expose the anterior longitudinal ligament.
  2. 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.
  3. 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.
  4. Dissection of the Yabuki space to control the entrance of the ureters into the bladder during anterior compartment dissection.
  5. Performing a hysterectomy and suturing the vaginal cup if additional gynecological indications are present. (in women with a uterus).
  6. 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.
  7. 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.
  8. 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.
  9. 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).
  10. Finally, providing peritonization with 2.0 vicryl and, if indicated, culdoplasty.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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).
Primary Purpose: Treatment
Official Title: Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique
Actual Study Start Date : July 15, 2022
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : April 15, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Meshless Approach
Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse.
 Procedure: Laparoscopic Meshless Sacrocolpopexy Technique
Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse


Outcome Measures
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Primary Outcome Measures :
  1. Visual analog Scale [ Time Frame: 6 months after the operation ]
    Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.

  2. POP-Q classification [ Time Frame: 6 months after the operation ]
    examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.

  3. PQOL [ Time Frame: 6 months after the operation ]
    Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.

  4. FSFI [ Time Frame: 6 months after the operation ]
    Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.

  5. Urinary Incontinance [ Time Frame: 6 months after the operation ]
    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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients in between 30 to 80 years old with a symptomatic vaginal cuff/uterine prolapse and/or cyctocele
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558852


Contacts
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Contact: Resul Karakus, MD 05059164216 resul-karakus@hotmail.com

Locations
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Turkey
Zeynep Kamil Maternity and Childrens Training and Research Hospital Recruiting
Istanbul, Turkey, 34660
Contact: Resul Karakus, MD    +905059164216    resul-karakus@hotmail.com   
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
More Information
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Responsible Party: Resul Karakuş, Principle Investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT05558852    
Other Study ID Numbers: 84/2022
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital:
Laparoscopy
Pelvic Organ Prolapse
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical