Back to resultsLaparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
Primary Purpose
Renal Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hand assisted laparoscopic nephrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cancer focused on measuring Laparoscopic nephrectomy, one day surgery
Eligibility Criteria
Inclusion criteria:
- Patient between 25-80 years old.
- Diagnosed as Cancer Renis
- Can read and understand Danish
- No cardiac disease lead to close cardiologic observations
- Any T, any N any M stadia.
Exclusion criteria:
- Mentally sick patient
- Dement
- Living alone
- Cardiac problem
- Per operative bleeding with the need to blood transfusion
- Operation time at afternoon
Sites / Locations
- Roskilde Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Laparoscopic nephrectomy
Hand assisted laparoscopic nephrectomy
Arm Description
Patient with renal cell carcenoma will undergo laparoscopic nephrectomy within standarized technique
Patient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy
Outcomes
Primary Outcome Measures
postoperative hospital admission
Secondary Outcome Measures
Full Information
NCT ID
NCT02295982
First Posted
November 17, 2014
Last Updated
January 22, 2018
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02295982
Brief Title
Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer
Keywords
Laparoscopic nephrectomy, one day surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic nephrectomy
Arm Type
Placebo Comparator
Arm Description
Patient with renal cell carcenoma will undergo laparoscopic nephrectomy within standarized technique
Arm Title
Hand assisted laparoscopic nephrectomy
Arm Type
Active Comparator
Arm Description
Patient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy
Intervention Type
Procedure
Intervention Name(s)
Hand assisted laparoscopic nephrectomy
Intervention Description
patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
Primary Outcome Measure Information:
Title
postoperative hospital admission
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patient between 25-80 years old.
Diagnosed as Cancer Renis
Can read and understand Danish
No cardiac disease lead to close cardiologic observations
Any T, any N any M stadia.
Exclusion criteria:
Mentally sick patient
Dement
Living alone
Cardiac problem
Per operative bleeding with the need to blood transfusion
Operation time at afternoon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nessn H Azawi
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roskilde Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
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