Ambulant Laparoscopic Nephrectomy; Are There Limiting Factors
Condition: Nephrectomy
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Ambulant laparoscopic nephrectomy
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research