Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 21-2.11.07 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma.
In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina. |
|
| 2 | Active Comparator | NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOTES Transvaginal Cholecystectomy | Procedure | The gallbladder will be dissected free and will be removed through an incision in the vagina. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES | continuous |
| Measure | Description | Time Frame |
|---|---|---|
| TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH | continuous |
Not provided
Inclusion Criteria for group #1 Transvaginal cholecystectomy:
Exclusion Criteria for group #1 Transvaginal cholecystectomy:
Inclusion Criteria for group #2 Transvaginal appendectomy:
Exclusion Criteria for group #2 Transvaginal appendectomy:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yoav Mintz, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | 12000 | Israel | |||
| Hadassah Medical Organization |
Not provided
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NOTES Transvaginal Appendectomy | Procedure | The appendix will be dissected free and will be removed through an incision in the vagina. |
|
| Jerusalem |
| Israel |
| D005759 |
| Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |