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Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
laparoscopic nerve-sparing radical hysterectomy-type III/C1
laparoscopic radical hysterectomy (type III/C2).
Sponsored by
Osama Mohammad Ali ElDamshety
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring nerve sparing radical hysterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Largo Agostino Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (A)

Group (B)

Arm Description

laparoscopic nerve sparing radical hysterectomy type III/C1

laparoscopic radical hysterectomy type III/C2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intraoperative complications
intraoperative complications
Blood loss
Amount of blood intraoperative blood loss in ml. units
Operative time
Minutes for the surgical intervention
Early postoperative complication
Occurence of early postoperative complication within 30 days of operation
Late postoperative complication
complications related to surgery 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

Full Information

First Posted
August 12, 2015
Last Updated
March 2, 2018
Sponsor
Osama Mohammad Ali ElDamshety
Collaborators
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02524756
Brief Title
Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
Official Title
Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Osama Mohammad Ali ElDamshety
Collaborators
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
nerve sparing radical hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Active Comparator
Arm Description
laparoscopic nerve sparing radical hysterectomy type III/C1
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
laparoscopic radical hysterectomy type III/C2
Intervention Type
Procedure
Intervention Name(s)
laparoscopic nerve-sparing radical hysterectomy-type III/C1
Intervention Type
Procedure
Intervention Name(s)
laparoscopic radical hysterectomy (type III/C2).
Primary Outcome Measure Information:
Title
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
Description
Duration of postoperative catheterization untill PVR urine volume is less than 100 ml
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Intraoperative complications
Description
intraoperative complications
Time Frame
During Surgery
Title
Blood loss
Description
Amount of blood intraoperative blood loss in ml. units
Time Frame
Day of surgery
Title
Operative time
Description
Minutes for the surgical intervention
Time Frame
Day of surgery
Title
Early postoperative complication
Description
Occurence of early postoperative complication within 30 days of operation
Time Frame
30 days
Title
Late postoperative complication
Description
complications related to surgery more than 30 days postoperative
Time Frame
more than 30 days postoperative
Title
Bladder training exercise
Description
Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Gaballa, MS.c.
Organizational Affiliation
Assistant Lecturer of surgical oncology, Mansoura universitry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adel Taha Denewar, M.D., Ph.D
Organizational Affiliation
Head of surgical oncology department, Mansoura oncology centre, Mansoura university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giovanni Scambia, M.D.,Ph.D
Organizational Affiliation
Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Valerio Gallotta, M.D.
Organizational Affiliation
Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy
Official's Role
Study Director
Facility Information:
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
Facility Name
Largo Agostino Gemelli
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

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