Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: November 2016

Interventions

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

Arms, Groups and Cohorts

• Active Comparator: Group (A)
  • laparoscopic nerve sparing radical hysterectomy type III/C1
• Active Comparator: Group (B)
  • laparoscopic radical hysterectomy type III/C2

Clinical Trial Outcome Measures

Primary Measures

• Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
  • Time Frame: 1 month
  • Duration of postoperative catheterization untill PVR urine volume is less than 100 ml

Secondary Measures

• Intraoperative complications
  • Time Frame: During Surgery
  • intraoperative complications
• Blood loss
  • Time Frame: Day of surgery
  • Amount of blood intraoperative blood loss in ml. units
• Operative time
  • Time Frame: Day of surgery
  • Minutes for the surgical intervention
• Early postoperative complication
  • Time Frame: 30 days
  • Occurence of early postoperative complication within 30 days of operation
• Late postoperative complication
  • Time Frame: more than 30 days postoperative
  • complications related to surgery more than 30 days postoperative
• Bladder training exercise
  • Time Frame: 1 month
  • Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Osama Mohammad Ali ElDamshety
• Collaborator
  • Catholic University of the Sacred Heart
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Osama Mohammad Ali ElDamshety, surgical oncology – Mansoura University
• Overall Official(s)
  • Khaled Gaballa, MS.c., Principal Investigator, Assistant Lecturer of surgical oncology, Mansoura universitry
  • Adel Taha Denewar, M.D., Ph.D, Study Chair, Head of surgical oncology department, Mansoura oncology centre, Mansoura university
  • Giovanni Scambia, M.D.,Ph.D, Study Director, Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, Italy
  • Valerio Gallotta, M.D., Study Director, Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy