NCT02524756

Brief Summary

The aim of this study is to assess:

  1. 1.Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.
  2. 2.Evaluate patients' outcome as regard bladder function.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

August 12, 2015

Last Update Submit

March 2, 2018

Conditions

Cervical Cancer

Keywords

nerve sparing radical hysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Intraoperative complications

    During Surgery

  • Blood loss

    Day of surgery

  • Operative time

    Day of surgery

  • Early postoperative complication

    30 days

  • Late postoperative complication

    more than 30 days postoperative

  • +1 more secondary outcomes

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

laparoscopic nerve sparing radical hysterectomy type III/C1

Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1

Group (B)

ACTIVE COMPARATOR

laparoscopic radical hysterectomy type III/C2

Procedure: laparoscopic radical hysterectomy (type III/C2).

Interventions

laparoscopic nerve-sparing radical hysterectomy-type III/C1PROCEDURE
Group (A)
laparoscopic radical hysterectomy (type III/C2).PROCEDURE
Group (B)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non Invasive Cancer
  • Pregnancy
  • Bladder dysfunction detected prior to surgery.
  • Previous pelvic lymphadenectomy.
  • Tumour recurrence
  • Incomplete surgery, unresectable lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Largo Agostino Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Khaled Gaballa, MS.c.

    Assistant Lecturer of surgical oncology, Mansoura universitry

    PRINCIPAL INVESTIGATOR

  • Adel Taha Denewar, M.D., Ph.D

    Head of surgical oncology department, Mansoura oncology centre, Mansoura university

    STUDY CHAIR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
surgical oncology

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 17, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

IT(1)EG(1)