Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

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 Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1; Procedure: laparoscopic radical hysterectomy (type III/C2).

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35511
• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Largo Agostino Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Osama Mohammad Ali ElDamshety
• Collaborators: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Khaled Gaballa, MS.c., Assistant Lecturer of surgical oncology, Mansoura universitry; Study Chair: Adel Taha Denewar, M.D., Ph.D, Head of surgical oncology department, Mansoura oncology centre, Mansoura university; Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: nerve sparing radical hysterectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: LNS-RH