Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01348620
Status:
UNKNOWN
Last Update Posted:
2011-05-05
First Post:
2011-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
Sponsor:
IRCCS Sacro Cuore Don Calabria di Negrar
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-05
Last Known Status:
RECRUITING
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:
This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
Detailed Description:
The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies.
The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies.
The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.
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?: