NCT02295982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

November 17, 2014

Last Update Submit

January 22, 2018

Conditions

Renal Cancer

Keywords

Laparoscopic nephrectomyone day surgery

Outcome Measures

Primary Outcomes (1)

  • postoperative hospital admission

    one day

Study Arms (2)

Laparoscopic nephrectomy

PLACEBO COMPARATOR

Patient with renal cell carcenoma will undergo laparoscopic nephrectomy within standarized technique

Procedure: Hand assisted laparoscopic nephrectomy

Hand assisted laparoscopic nephrectomy

ACTIVE COMPARATOR

Patient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy

Procedure: Hand assisted laparoscopic nephrectomy

Interventions

Hand assisted laparoscopic nephrectomyPROCEDURE

patients with renal cancer will undergo hans assisted laparoscopic nephrectomy

Hand assisted laparoscopic nephrectomyLaparoscopic nephrectomy

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Mentally sick patient
  • Dement
  • Living alone
  • Cardiac problem
  • Per operative bleeding with the need to blood transfusion
  • Operation time at afternoon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roskilde Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Nessn H Azawi

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Urologist

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 20, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

DK(1)