Cervical Cancer
Conditions
Keywords
nerve sparing radical hysterectomy
Brief summary
The aim of this study is to assess: 1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time. 2. Evaluate patients' outcome as regard bladder function. 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
Interventions
PROCEDURElaparoscopic nerve-sparing radical hysterectomy-type III/C1
PROCEDURElaparoscopic radical hysterectomy (type III/C2).
Sponsors
Catholic University of the Sacred Heart
Osama Mohammad Ali ElDamshety
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years. 2. Karnofsky \> 80, or American Society of anaethesiology (ASA) I-II 3. Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging. 4. Stage II, III endometrial cancer
Exclusion criteria
1. Non Invasive Cancer 2. Pregnancy 3. Bladder dysfunction detected prior to surgery. 4. Previous pelvic lymphadenectomy. 5. Tumour recurrence 6. Incomplete surgery, unresectable lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1 | 1 month | Duration of postoperative catheterization untill PVR urine volume is less than 100 ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | Day of surgery | Amount of blood intraoperative blood loss in ml. units |
| Operative time | Day of surgery | Minutes for the surgical intervention |
| Intraoperative complications | During Surgery | intraoperative complications |
| Late postoperative complication | more than 30 days postoperative | complications related to surgery more than 30 days postoperative |
| Bladder training exercise | 1 month | Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume |
| Early postoperative complication | 30 days | Occurence of early postoperative complication within 30 days of operation |
Countries
Egypt, Italy
Outcome results
None listed