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| Name | Class |
|---|---|
| Catholic University of the Sacred Heart | OTHER |
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The aim of this study is to assess:
in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.
The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.
Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (A) | Active Comparator | laparoscopic nerve sparing radical hysterectomy type III/C1 |
|
| Group (B) | Active Comparator | laparoscopic radical hysterectomy type III/C2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic nerve-sparing radical hysterectomy-type III/C1 | Procedure |
| ||
| laparoscopic radical hysterectomy (type III/C2). |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1 | Duration of postoperative catheterization untill PVR urine volume is less than 100 ml | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | intraoperative complications | During Surgery |
| Blood loss | Amount of blood intraoperative blood loss in ml. units |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaled Gaballa, MS.c. | Assistant Lecturer of surgical oncology, Mansoura universitry | Principal Investigator |
| Adel Taha Denewar, M.D., Ph.D | Head of surgical oncology department, Mansoura oncology centre, Mansoura university | Study Chair |
| Giovanni Scambia, M.D.,Ph.D | Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, Italy | Study Director |
| Valerio Gallotta, M.D. | Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Mansurah | Dakahlia Governorate | 35511 | Egypt | |||
| Largo Agostino Gemelli |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Procedure |
|
| Day of surgery |
| Operative time | Minutes for the surgical intervention | Day of surgery |
| Early postoperative complication | Occurence of early postoperative complication within 30 days of operation | 30 days |
| Late postoperative complication | complications related to surgery more than 30 days postoperative | more than 30 days postoperative |
| Bladder training exercise | Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume | 1 month |
| Roma |
| RM |
| 00168 |
| Italy |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |