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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558852
• Other study ID #: 84/2022
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: September 2022
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: Resul Karakus, MD
• Phone: 05059164216
• Email: resul-karakus[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy
• Prolapse

Intervention

Procedure:
• Laparoscopic Meshless Sacrocolpopexy Technique
Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Maternity and Childrens Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog Scale	Pain Scale of 0 to 10, aiming that the operation itself leaves no pain.	6 months after the operation
Primary	POP-Q classification	examination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.	6 months after the operation
Primary	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
Primary	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
Primary	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