Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01348620|
Recruitment Status : Unknown
Verified May 2011 by IRCCS Sacro Cuore Don Calabria di Negrar.
Recruitment status was: Recruiting
First Posted : May 5, 2011
Last Update Posted : May 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa) Procedure: Four port laparoscopic cholecystectomy surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||January 2012|
|Experimental: Single port laparoscopic device||
Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
Other Name: One-trocar cholecistectomy
|Active Comparator: Four-port laparoscopic device||
Procedure: Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery
Other Name: traditional Laparoscopic cholecistectomy
- Post-operative pain scores (visual analogue pain scale from 0-10) [ Time Frame: Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery ]
- Patient-assessed cosmesis on the Visual Analogue Scale [ Time Frame: 30 days after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348620
|Contact: Giuliano Barugola, MDemail@example.com|
|Sacro Cuore - Don Calabria Hospital||Recruiting|
|Negrar, Verona, Italy, 37024|
|Contact: Giuliano Barugola, MD firstname.lastname@example.org|
|Principal Investigator: Giacomo Ruffo, MD|
|Sub-Investigator: Giuliano Barugola, MD|
|Sub-Investigator: Alberto Sartori, MD|
|Sub-Investigator: Stefano crippa, MD|
|Sub-Investigator: Stefano Partelli, MD|