Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592020
• Other study ID #: 220/07
• Status: Completed
• Phase: N/A
• First received: December 31, 2007
• Last updated: May 20, 2011
• Start date: January 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age equal or over 18 years

• Sole kidney transplantation

• Consent form

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• Short Transverse Incision
Short Transverse Incision for kidney transplantation
• Hockey Stick Incision
Hockey Stick Incision for kidney transplantation

Locations

Country	Name	City	State
Switzerland	University Hospital Inselspital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR (Quality of Recovery) - Score		preoperative, day 1/3/5/7 postoperative	No
Secondary	Quality of Life by SF (Short Form) 36		preoperative, day 7, week 4, month 6 postoperative	No
Secondary	Operation time		intraoperative	No
Secondary	Warm ischemic time		intraoperative	No
Secondary	Postoperative pain measured by VAS (visual analog scale) and amount of analgesia		day 1/2/3/4/5/6/7 postoperative	No
Secondary	Surgical complications		day 7, week 4, month 6, month 12 postoperative	No