Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)

January 22, 2018 updated by: Nessn Azawi, Zealand University Hospital
The purpose of this study is to describe the postoperative outcomes after laparoscopic transperitoneal nephrectomy and compare them with hand assisted laparoscopic nephrectomy with a focus on the limiting factors that prevent an ambulatory nephrectomy, and the benefit of our experiences from the previous study to optimize the postoperative outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Roskilde Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patient between 25-80 years old.
  2. Diagnosed as Cancer Renis
  3. Can read and understand Danish
  4. No cardiac disease lead to close cardiologic observations
  5. Any T, any N any M stadia.

Exclusion criteria:

  1. Mentally sick patient
  2. Dement
  3. Living alone
  4. Cardiac problem
  5. Per operative bleeding with the need to blood transfusion
  6. Operation time at afternoon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Laparoscopic nephrectomy
Patient with renal cell carcenoma will undergo laparoscopic nephrectomy within standarized technique
Procedure: Hand assisted laparoscopic nephrectomy
patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
Active Comparator: Hand assisted laparoscopic nephrectomy
Patient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy
Procedure: Hand assisted laparoscopic nephrectomy
patients with renal cancer will undergo hans assisted laparoscopic nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative hospital admission
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Nessn H Azawi, Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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