Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:
One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy:
Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.
Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port sacrocolpopexy | Active Comparator | Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy. |
|
| Multi-port sacrocolpopexy | Active Comparator | Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port sacrocolpopexy | Procedure | Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of surgical time | Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy. | Up to four months (2 weeks before surgery until 3 months post-surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of surgical success | Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy. | Up to four months (2 weeks before surgery until 3 months post-surgery). |
| Comparison of surgical complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female patients.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roy Lauterbach, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31589864 | Derived | Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Multi-port sacrocolpopexy | Procedure | Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse. |
|
Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.
| Up to four months (2 weeks before surgery until 3 months post-surgery). |