Clinical trial NCT05558852: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Prolapse Uterovaginal
Prolapse Bladder
Laparoscopy
Keywords: Laparoscopy
Pelvic Organ Prolapse
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Anticipated 25 patients will be evaluated and operated with meshless method.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analog Scale
timeFrame: 6 months after the operation
measure: POP-Q classification
timeFrame: 6 months after the operation
measure: PQOL
timeFrame: 6 months after the operation
measure: FSFI
timeFrame: 6 months after the operation
measure: Urinary Incontinance
timeFrame: 6 months after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Childrens Training and Research Hospital
Study officials:
References: