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

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

Tracking Information

• First Submitted Date: September 25, 2022
• First Posted Date: September 28, 2022
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: July 15, 2022
• Estimated Primary Completion Date: October 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2022)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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;

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Prolapse Uterovaginal
• Prolapse Bladder
• Laparoscopy

Intervention

Procedure: Laparoscopic Meshless Sacrocolpopexy Technique

Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse

Study Arms

Experimental: Meshless Approach

Laparoscopic Sacrocolpopexy in central or anterior compartment prolapse.

Intervention: Procedure: Laparoscopic Meshless Sacrocolpopexy Technique

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 25, 2022): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 15, 2023
• Estimated Primary Completion Date: October 15, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• 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

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT05558852
• Other Study ID Numbers: 84/2022
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Original Responsible Party: Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, MD
• Current Study Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Verification Date: September 2022