Ambulant Laparoscopic Nephrectomy; Are There Limiting Factors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital Roskilde
Sponsor:
Information provided by (Responsible Party):
Nessn Azawi, University Hospital Roskilde
ClinicalTrials.gov Identifier:
NCT01600157
First received: May 12, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

Background Fast-track concepts reduced hospital stay from 15-20 days to three days for patients who underwent a colon resection [1-5]. A well-designed pilot study determined the efficacy of a fast-track program for a laparoscopic radical nephrectomy, and the fast-track group was discharged earlier from the recovery room median (74+/-23 v 103+/-47 minutes) as well as from the hospital median (41+/-11 v 59+/-11 hours) [6]. Implementation of the principles of the fast-track program shortened the postoperative hospital stay from eight to four days for patients who underwent an open radical nephrectomy [7]. Taek-Gu Lee et al. documented how early mobilization after colon surgery resulted in reduced recovery times without increased complications [8]. Laparoscopic surgery is minimal invasive with less surgical stress, morbidity and mortality [9]. The use of laparoscopic nephrectomy in Denmark reduces the hospital stay to 5.2 days which did not meet the foreign countries outcome [06].

Therefore a combination of the advantages of laparoscopic surgery and the fast-track concepts could be used by nephrectomies. However, no prospective studies describing the course after nephrectomies, where these advantages are exploited and it is important to make a basic study to describe and understand the factors of surgical outcome.

Aim of study To describe the postoperative period after laparoscopic trans-peritoneal nephrectomy that performed as an ambulatory procedure.

Method A prospective study will involve 62 patients who have been diagnosed with Cancer Renis DC649.

All patients will receive the results of CT-scanning at outpatient and of them who meet the inclusion criteria for the study will be informed about the study and will receive a written information according to appendix 1., and a new time with (NA) to get the results for kidney function and oral information about the study as well as their acceptation to be connected to the study, those patients will receive a standard recommendation to be discharged from hospital on the day of their operation and they will restart their normal activities the day after the operation unless there are preventing factors. All patients will be thoroughly informed by the examiner how to complete the questionnaire and will come through different tests according to appendix 2., a blood test will be taken according to appendix 12.

All patients should have a CT-scanning of abdomen, chest X-ray and kidney function test before the operations.

Statistic The number of patients, have been decided to be included to each study, is based on the realized number of nephrectomy operations that can be done during the specified period within each department and not on the statistic power of study.

The Scheffé's test will be used for multiple comparisons. The correlation between variables will be evaluated by using the Spearman's rank correlation coefficient. P values less than 0.05 is considered significant. Statistical analyses will be performed by SPSS statistic program software.

Publications The results of each study, irrespective of whether these are positive or negative, will be published in international scientific journals and will be distributed at relative conferences. The published articles will have Azawi NH as first author, Christensen T as last author and co-authors according to Vancouver rules.

Ethics The study will be reported to the Danish National Committee on Biomedical Research Ethics and regionsjaelland paraplygodtkendelsen data control, Ph.D. student (NA) will apply for enrollment to the PhD programme at the University of Copenhagen. Consent forms will be received from all patients and they will receive written information about project. The project will protect all of the data gathered.


Condition Intervention
Nephrectomy
Procedure: Ambulant laparoscopic nephrectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Ambulant Laparoscopic Nephrectomy

Resource links provided by NLM:


Further study details as provided by University Hospital Roskilde:

Primary Outcome Measures:
  • Identification of the limiting factors for ambulant laparoscopic nephrectomy [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    The patient will asked a direct question after the operation if they can not be discharged at the operation day. what is the main reason not to be discharged at this time?

  • Identification of the limiting factors for ambulant laparoscopic nephrectomy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The patient will asked a direct question after the operation if they can not be discharged at the operation day. what is the main reason not to be discharged at this time?

  • Identification of the limiting factors for ambulant laparoscopic nephrectomy [ Time Frame: 2 day ] [ Designated as safety issue: No ]
    The patient will asked a direct question after the operation if they can not be discharged at the operation day. what is the main reason not to be discharged at this time?

  • Identification of the limiting factors for ambulant laparoscopic nephrectomy [ Time Frame: 3 day ] [ Designated as safety issue: No ]
    The patient will asked a direct question after the operation if they can not be discharged at the operation day. what is the main reason not to be discharged at this time?

  • Identification of the limiting factors for ambulant laparoscopic nephrectomy [ Time Frame: 4 day ] [ Designated as safety issue: No ]
    The patient will asked a direct question after the operation if they can not be discharged at the operation day. what is the main reason not to be discharged at this time?


Secondary Outcome Measures:
  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 2 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 3 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 4 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 5 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 10 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.

  • Pain,Nausea,Vomiting,Fatigue,Dizziness [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    The postoperative period of 30 days will be observed by using visual analog skala (VAS)for Pain,Nausea,Vomiting,Fatigue,Dizziness.


Estimated Enrollment: 62
Study Start Date: April 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic Nephrectomy Procedure: Ambulant laparoscopic nephrectomy
The patients with a renal cancer diagnosis with be schedule to enter the project if they meet the inclusion criteria of the project and the postoperative period will be recorded to identified the limiting factors for ambulant laparoscopic nephrectomy.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient between 30-70 years old.
  2. Diagnosed as Cancer Renis
  3. Can read and understand Danish
  4. No cardiac disease
  5. No metastatic disease

Exclusion Criteria:

  1. Mentally sick patient
  2. Dement
  3. Living alone
  4. Cardiac problem
  5. Multiple surgery previously
  6. Per operative bleeding with the need to blood transfusion
  7. Operation time at afternoon
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600157

Contacts
Contact: Nessn Htum Azawi, M.D. +4526393034 nesa@regionsjaelland.dk

Locations
Denmark
Roskilde Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Tom Christensen, Dr.med.    +454732350    thc@regionsjaelland.dk   
Sponsors and Collaborators
University Hospital Roskilde
Investigators
Principal Investigator: Nessn Htum Azawi, M.D. Roskilde Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Nessn Azawi, senior urologist, University Hospital Roskilde
ClinicalTrials.gov Identifier: NCT01600157     History of Changes
Other Study ID Numbers: SJ-267
Study First Received: May 12, 2012
Last Updated: April 22, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on October 22, 2014