Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique
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|ClinicalTrials.gov Identifier: NCT05558852|
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : September 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prolapse Uterovaginal Prolapse Bladder Laparoscopy||Procedure: Laparoscopic Meshless Sacrocolpopexy Technique||Not Applicable|
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 anterior promontory and the presacral area are dissected to expose the anterior longitudinal ligament.
- 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.
- 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.
- Dissection of the Yabuki space to control the entrance of the ureters into the bladder during anterior compartment dissection.
- Performing a hysterectomy and suturing the vaginal cup if additional gynecological indications are present. (in women with a uterus).
- 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.
- 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.
- 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.
- 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).
- Finally, providing peritonization with 2.0 vicryl and, if indicated, culdoplasty.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|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).|
|Official Title:||Laparoscopic Central and Anterior Compartment Prolapse Surgery: A Meshless Sacrocolpopexy Technique|
|Actual Study Start Date :||July 15, 2022|
|Estimated Primary Completion Date :||October 15, 2022|
|Estimated Study Completion Date :||April 15, 2023|
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558852
|Contact: Resul Karakus, MDfirstname.lastname@example.org|
|Zeynep Kamil Maternity and Childrens Training and Research Hospital||Recruiting|
|Istanbul, Turkey, 34660|
|Contact: Resul Karakus, MD +905059164216 email@example.com|