Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-30 @ 6:10 AM
Study NCT ID:
NCT01203566
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2010-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
A Double-blinded Randomised Controlled Trial of Laparoendoscopic Single-site Access (LESS) Versus Conventional Three-port Appendicectomy.
Status:
COMPLETED
Status Verified Date:
2010-09
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:
LESS laparoscopic appendectomy is associated with less pain than conventional 3-port laparoscopic appendectomy.
Detailed Description:
Since the original description in the 1970's, the laparoscopic approach to management of surgical diseases has gained widespread acceptance. It has been shown to be associated with decreased wound pain, analgesic requirements, hospital stay and allows improved cosmesis and quality of life without significantly increasing the risks of morbidities and mortalities. With continued improvements in technology, however, efforts to reduce the number of abdomen wounds in an attempt to further decrease pain, improve cosmesis and outcomes are underway. Natural Orifices Transluminal Endoscopic Surgery (NOTES) has received widespread attention in both the medical field as well as the general public. However, there are still a multitude of problems that needs to be solved before the technique can be broadly applied to human subjects \[7\]. On the other hand, a renewed interest in single incision laparoscopic surgeries is emerging. The approach has been shown to be safe and feasible in our experience as well as the others. It also has the potential to further decrease the surgical trauma induced to the patient and to improve cosmesis.
Since laparoscopic appendicectomy is one of the most basic procedures in laparoscopic surgery, it is an appropriate model for initial evaluation of single incision laparoscopic surgery. Our unit has already performed 20 cases of single site access laparoscopic appendicectomy (SSALA) and so far, the results have been encouraging (data pending publication). All the patients in the series had their procedures completed with a single incision. None of the patients suffered from adverse events and all had resumption of oral diet by day 1 and were discharged on day 2 post-operatively. However, whether the approach is more beneficial as compared to conventional three-port laparoscopic appendicectomy is still uncertain.
Hence, the aim of the current study is to compare the approach of SSALA to conventional three-port laparoscopic appendicectomy in reducing surgical trauma and improving cosmesis to the patient.
Since laparoscopic appendicectomy is one of the most basic procedures in laparoscopic surgery, it is an appropriate model for initial evaluation of single incision laparoscopic surgery. Our unit has already performed 20 cases of single site access laparoscopic appendicectomy (SSALA) and so far, the results have been encouraging (data pending publication). All the patients in the series had their procedures completed with a single incision. None of the patients suffered from adverse events and all had resumption of oral diet by day 1 and were discharged on day 2 post-operatively. However, whether the approach is more beneficial as compared to conventional three-port laparoscopic appendicectomy is still uncertain.
Hence, the aim of the current study is to compare the approach of SSALA to conventional three-port laparoscopic appendicectomy in reducing surgical trauma and improving cosmesis to the patient.
Study Oversight
Has Oversight DMC:
True
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?: