MedTrace Logo

Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

NCT02524756 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-03-06

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

laparoscopic nerve-sparing radical hysterectomy-type III/C1

PROCEDURE

laparoscopic radical hysterectomy (type III/C2).

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Osama Mohammad Ali ElDamshety

    lead OTHER

Principal Investigators

  • Khaled Gaballa, MS.c. · Assistant Lecturer of surgical oncology, Mansoura universitry

  • Adel Taha Denewar, M.D., Ph.D · Head of surgical oncology department, Mansoura oncology centre, Mansoura university

  • 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

  • Valerio Gallotta, M.D. · Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Egypt
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02524756 on ClinicalTrials.gov