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Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

Primary Purpose

Kidney Transplantation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Short Transverse Incision
Hockey Stick Incision
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring kidney, transplantation, minimal invasive, short transverse, hockey stick, incision, quality of life, planned kidney transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age equal or over 18 years
  • Sole kidney transplantation
  • Consent form

Sites / Locations

  • University Hospital Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Short Transverse Incision

Hockey Stick Incision

Outcomes

Primary Outcome Measures

QoR (Quality of Recovery) - Score

Secondary Outcome Measures

Quality of Life by SF (Short Form) 36
Operation time
Warm ischemic time
Postoperative pain measured by VAS (visual analog scale) and amount of analgesia
Surgical complications

Full Information

First Posted
December 31, 2007
Last Updated
May 20, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00592020
Brief Title
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation
Official Title
"Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection). Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic. The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation
Keywords
kidney, transplantation, minimal invasive, short transverse, hockey stick, incision, quality of life, planned kidney transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Short Transverse Incision
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hockey Stick Incision
Intervention Type
Procedure
Intervention Name(s)
Short Transverse Incision
Intervention Description
Short Transverse Incision for kidney transplantation
Intervention Type
Procedure
Intervention Name(s)
Hockey Stick Incision
Intervention Description
Hockey Stick Incision for kidney transplantation
Primary Outcome Measure Information:
Title
QoR (Quality of Recovery) - Score
Time Frame
preoperative, day 1/3/5/7 postoperative
Secondary Outcome Measure Information:
Title
Quality of Life by SF (Short Form) 36
Time Frame
preoperative, day 7, week 4, month 6 postoperative
Title
Operation time
Time Frame
intraoperative
Title
Warm ischemic time
Time Frame
intraoperative
Title
Postoperative pain measured by VAS (visual analog scale) and amount of analgesia
Time Frame
day 1/2/3/4/5/6/7 postoperative
Title
Surgical complications
Time Frame
day 7, week 4, month 6, month 12 postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age equal or over 18 years Sole kidney transplantation Consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uta Herden, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Inselspital
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

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