Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258986
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2005-11-23
Brief Title:
Efficacy Study Comparing Hand-assisted Laparoscopic and Mini-incision Muscle Splitting Incision Living Donor Nephrectomy
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Comparisons The study compares the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors
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
Comparisons The study compares the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None