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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopy; Prolapse Uterovaginal; Prolapse Bladder
• Intervention / Treatment: Procedure: Laparoscopic Meshless Sacrocolpopexy Technique

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
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Resul Karakus, MD; Phone Number: 05059164216; Email: resul-karakus@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34660
    • Recruiting
    • Zeynep Kamil Maternity and Childrens Training and Research Hospital
    • Contact: Resul Karakus, MD; Phone Number: +905059164216; Email: resul-karakus@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog Scale	Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.	6 months after the operation
POP-Q classification	examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.	6 months after the operation
PQOL	Aiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.	6 months after the operation
FSFI	Aiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.	6 months after the operation
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)	6 months after the operation

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: September 25, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Laparoscopy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 84/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No