Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

"Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Procedure: Short Transverse Incision; Procedure: Hockey Stick Incision

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • University Hospital Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Short Transverse Incision	Procedure: Short Transverse Incision; Short Transverse Incision for kidney transplantation
Active Comparator: 2; Hockey Stick Incision	Procedure: Hockey Stick Incision; Hockey Stick Incision for kidney transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QoR (Quality of Recovery) - Score	preoperative, day 1/3/5/7 postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Operation time	intraoperative
Quality of Life by SF (Short Form) 36	preoperative, day 7, week 4, month 6 postoperative
Warm ischemic time	intraoperative
Postoperative pain measured by VAS (visual analog scale) and amount of analgesia	day 1/2/3/4/5/6/7 postoperative
Surgical complications	day 7, week 4, month 6, month 12 postoperative

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Uta Herden, MD, University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 31, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimate): January 11, 2008

Study Record Updates

• Last Update Posted (Estimate): May 23, 2011
• Last Update Submitted That Met QC Criteria: May 20, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: quality of life; transplantation; kidney; minimal invasive; incision; short transverse; hockey stick; planned kidney transplantation
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 220/07