NCT00592020

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

3.3 years

First QC Date

December 31, 2007

Last Update Submit

May 20, 2011

Conditions

Kidney Transplantation

Keywords

kidneytransplantationminimal invasiveshort transversehockey stickincisionquality of lifeplanned kidney transplantation

Outcome Measures

Primary Outcomes (1)

  • QoR (Quality of Recovery) - Score

    preoperative, day 1/3/5/7 postoperative

Secondary Outcomes (5)

  • Quality of Life by SF (Short Form) 36

    preoperative, day 7, week 4, month 6 postoperative

  • Operation time

    intraoperative

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Short Transverse Incision

Procedure: Short Transverse Incision

2

ACTIVE COMPARATOR

Hockey Stick Incision

Procedure: Hockey Stick Incision

Interventions

Short Transverse IncisionPROCEDURE

Short Transverse Incision for kidney transplantation

1
Hockey Stick IncisionPROCEDURE

Hockey Stick Incision for kidney transplantation

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Uta Herden, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

CH(1)