Laparoscopic Versus Hand Assisted Laparoscopic Trans-peritoneal Laparoscopic Nephrectomy as One Day Surgery (i.e.: Are There Differences in Postoperative Outcome / Convalescence)

NCT ID: NCT02295982

Last Updated: 2018-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic nephrectomy

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

Group Type PLACEBO_COMPARATOR

Hand assisted laparoscopic nephrectomy

Intervention Type PROCEDURE

patients with renal cancer will undergo hans assisted laparoscopic nephrectomy

Hand assisted laparoscopic nephrectomy

Patient with renal cell carcenoma will undergo hand assisted laparoscopic nephrectomy

Group Type ACTIVE_COMPARATOR

Hand assisted laparoscopic nephrectomy

Intervention Type PROCEDURE

patients with renal cancer will undergo hans assisted laparoscopic nephrectomy

Interventions

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Hand assisted laparoscopic nephrectomy

patients with renal cancer will undergo hans assisted laparoscopic nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient between 25-80 years old.
2. Diagnosed as Cancer Renis
3. Can read and understand Danish
4. No cardiac disease lead to close cardiologic observations
5. Any T, any N any M stadia.

Exclusion Criteria

1. Mentally sick patient
2. Dement
3. Living alone
4. Cardiac problem
5. Per operative bleeding with the need to blood transfusion
6. Operation time at afternoon
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nessn Azawi

Consultant Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nessn H Azawi

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

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Roskilde Hospital

Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SJ-416

Identifier Type: -

Identifier Source: org_study_id

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