Efficacy Study Comparing Hand-assisted Laparoscopic and Mini-incision Muscle Splitting Incision Living Donor Nephrectomy

Living Donors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258986
• Other study ID #: UMCG/166.478/RvB
• Status: Completed
• Phase: Phase 3
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: March 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors. The hypothesis is that the mini-incision is not inferior to the laparoscopic technique.

Description:

Living kidney donation has become an important source for kidney transplantation because of insufficient numbers of post mortem kidney donations. To reduce the surgical trauma of the donor operation and improve postoperative recovery minimal invasive techniques have developed. Especially the laparoscopic and the hand-assisted laparoscopic technique gained wide popularity. Minimal invasive open techniques have had less publicity. One of those open techniques is to perform the open donornephrectomy by means of an anterolateral approach. A transverse subcostal incision of 10 cm or less is made. The abdominal wall is opened by splitting the muscles and sparing the nerves. Staying in the retroperitoneal space the kidney is freed and taken out. Laparoscopic approaches have especially become more popular after the hand-assisted technique had developed. By means of an 8 cm transverse suprapubic skin incision and a vertical midline fascia incision the abdominal cavity is opened and a hand is inserted in the abdomen through an air tight sleeve. Three more trocarts are needed for the insufflation, the video camera and surgical instruments to perform a transperitoneal donornephrectomy. The hand in the abdomen assisting in the procedure has especially increased the sense of safety compared to the full laparoscopic technique without compromising the advantages of the laparoscopic technique.

So far no prospective or retrospective study has been done comparing the hand-assisted laparoscopic with the mini-incision muscle-splitting technique. Most studies that have been done comparing the (hand-assisted) laparoscopic technique with more invasive open techniques resulted in favour of the former technique.

Comparison(s): The study compares the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Accepted as living kidney donor by local protocol

• 18 years or older

• Excellent understanding of Dutch language

• Able to be operated on by both surgical techniques

• Having read patient information and signed informed consent

Exclusion Criteria:

• Previous surgery using subcostal incision(s)

• Not meeting the inclusion criteria

Related Conditions & MeSH terms

• Living Donors

Intervention

Procedure:
• Living donornephrectomy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triple pain measurement using linear Visual Analogue Scale (at rest, at coughing and in supine position lifting of straight legs)
Secondary	- CRP levels in first three days after the donor operation (indicative of the magnitude of the surgical trauma)
Secondary	- Abdominal wall muscle function (testing the functional integrity of the abdominal muscles)