Renal CancerNCT02295982
Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
A study testing Hand assisted laparoscopic nephrectomy in people with Renal Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Hand assisted laparoscopic nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mentally sick patient
- Dement
- Living alone
- Cardiac problem
- Per operative bleeding with the need to blood transfusion
- Operation time at afternoon
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Cancer
- Being tested
- Hand assisted laparoscopic nephrectomy
- Keywords
- Laparoscopic nephrectomy, one day surgery
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand assisted laparoscopic nephrectomyProcedure or surgery
patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic nephrectomy | Placebo comparator | Patient with renal cell carcenoma will undergo laparoscopic nephrectomy within standarized technique Receives: Procedure: Hand assisted laparoscopic nephrectomy |
| Hand assisted laparoscopic nephrectomy | Active comparator | Patient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy Receives: Procedure: Hand assisted laparoscopic nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hospital admission
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessn Azawi, Zealand University Hospital
- Investigators
- Nessn H Azawi, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295982
- Sponsor's protocol ID
- SJ-416
- Status last verified
- Jan 2018
- First submitted
- 17 Nov 2014
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)
- ClinicalTrials.gov ID
- NCT02295982
- Acronym / sponsor ID
- SJ-416
- Conditions
- Renal Cancer
- Keywords
- Laparoscopic nephrectomy, one day surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic nephrectomy | Placebo comparator | Procedure: Hand assisted laparoscopic nephrectomyPatient with renal cell carcenoma will undergo laparoscopic nephrectomy within standarized technique |
| Hand assisted laparoscopic nephrectomy | Active comparator | Procedure: Hand assisted laparoscopic nephrectomyPatient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Mentally sick patient
- Dement
- Living alone
- Cardiac problem
- Per operative bleeding with the need to blood transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand assisted laparoscopic nephrectomypatients with renal cancer will undergo hans assisted laparoscopic nephrectomy | Procedure or surgery | Hand assisted laparoscopic nephrectomy, Laparoscopic nephrectomy |
Primary outcome
postoperative hospital admission
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nessn H Azawi principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand assisted laparoscopic nephrectomy in people with Renal Cancer, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative hospital admission (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018; AzTrials last refreshed its copy on 31 Oct 2026.