Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Study Overview
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Brief Summary
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The aim of this study is to assess: Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time. 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

Official Title
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Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1
* Procedure: laparoscopic radical hysterectomy (type III/C2).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Karnofsky > 80, or American Society of anaethesiology (ASA) I-II Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging. Stage II, III endometrial cancer Exclusion Criteria: Non Invasive Cancer Pregnancy Bladder dysfunction detected prior to surgery. Previous pelvic lymphadenectomy. Tumour recurrence Incomplete surgery, unresectable lesion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group (A)<br>laparoscopic nerve sparing radical hysterectomy type III/C1 | Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1<br> <br> |
| Active Comparator: Group (B)<br>laparoscopic radical hysterectomy type III/C2 | Procedure: laparoscopic radical hysterectomy (type III/C2).<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | intraoperative complications | During Surgery | 
| Blood loss | Amount of blood intraoperative blood loss in ml. units | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve sparing radical hysterectomy