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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05558852
Enrollment
25
Registered
2022-09-28
Start date
2022-07-15
Completion date
2023-04-15
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopy, Prolapse Bladder, Prolapse Uterovaginal

Keywords

Laparoscopy, Pelvic Organ Prolapse

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.

Interventions

PROCEDURELaparoscopic Meshless Sacrocolpopexy Technique

Meshless sacrocolpopexy: laparoscopic approach to central and anterior compartment prolapse

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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).

Intervention model description

Anticipated 25 patients will be evaluated and operated with meshless method.

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog Scale6 months after the operationPain Scale of 0 to 10, aiming that the operation itself leaves no pain.
POP-Q classification6 months after the operationexamination of pelvis organs, aiming that the vaginal cuff stays at -2 level and no recur.
PQOL6 months after the operationAiming to see the increased quality of life by the questionnaire which is given preoperatively and postoperative 6th month.
FSFI6 months after the operationAiming to see the increased quality of sexual life by the questionnaire which is given preoperatively and postoperative 6th month.
Urinary Incontinance6 months after the operationQuestioning 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)

Countries

Turkey (Türkiye)

Contacts

Primary ContactResul Karakus, MD
resul-karakus@hotmail.com05059164216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026