Nephrectomy Clinical Trial
Official title:
Ambulant Laparoscopic Nephrectomy
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT03691935 -
Erector Spinae Plane Block (ESPB): in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision.
|
Phase 4 | |
Recruiting |
NCT01093079 -
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
|
N/A | |
Recruiting |
NCT04546230 -
Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.
|
N/A | |
Completed |
NCT05596669 -
Analgesic Effect of Ketamine Vs Ketamine Magnesium Infusion and Their Effect on Postoperative Morphine Consumption
|
Phase 1 | |
Enrolling by invitation |
NCT02287987 -
CLamp vs Off Clamp Kidney During Partial Nephrectomy
|
N/A | |
Terminated |
NCT01008709 -
Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery
|
N/A | |
Completed |
NCT00765232 -
Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
|
Phase 4 | |
Completed |
NCT03155295 -
Simulated Surgery Rehearsal (MIPN)
|
||
Completed |
NCT04402749 -
The Incidence of Pulmonary Embolism During Nephrectomy
|
||
Completed |
NCT01236326 -
Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation
|
N/A | |
Completed |
NCT06119568 -
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
|
N/A | |
Completed |
NCT03324490 -
Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
|
N/A | |
Not yet recruiting |
NCT06256120 -
Effect of Fluid Regimen on Acute Kidney Injury
|
N/A | |
Completed |
NCT03581539 -
Comparing 3 Different Types of Pain Blocks After Laparoscopic Nephrectomy
|
N/A | |
Active, not recruiting |
NCT03400085 -
Pilot Study of an mHealth Intervention for Living Donor Follow-up
|
N/A | |
Completed |
NCT03428633 -
Thoracic Paravertebral Blocks in Open Nephrectomy
|
Phase 2 | |
Active, not recruiting |
NCT03090646 -
Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance
|
N/A | |
Not yet recruiting |
NCT05106218 -
Assessment of the SurroundScope in Urologic Surgical Procedures
|
N/A | |
Completed |
NCT01054469 -
Transversus Abdominus Plane Block
|
N/A | |
Not yet recruiting |
NCT05149196 -
Goal-directed Hemodynamic Management and Kidney Injury After Radical Nephrectomy
|
N/A |