Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| Active Comparator: Four-port laparoscopic device
|
Procedure: Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Post-operative pain scores (visual analogue pain scale from 0-10) [Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery]
Secondary Outcome Measures
- Patient-assessed cosmesis on the Visual Analogue Scale [30 days after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Biliary cholic
-
Biliary dyskinesia
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Gallbladder polyps
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Other diagnosis at the discretion of the surgeon
Exclusion Criteria:
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History of Acute cholecystitis
-
Jaundice
-
Choledocolithiasis
-
History of Pancreatitis
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Severe comorbidity
-
BMI > 30
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sacro Cuore - Don Calabria Hospital | Negrar | Verona | Italy | 37024 |
Sponsors and Collaborators
- IRCCS Sacro Cuore Don Calabria di Negrar
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Gumbs AA, Milone L, Sinha P, Bessler M. Totally transumbilical laparoscopic cholecystectomy. J Gastrointest Surg. 2009 Mar;13(3):533-4. doi: 10.1007/s11605-008-0614-8.
- Hirano Y, Watanabe T, Uchida T, Yoshida S, Tawaraya K, Kato H, Hosokawa O. Single-incision laparoscopic cholecystectomy: single institution experience and literature review. World J Gastroenterol. 2010 Jan 14;16(2):270-4. Review.
- Kuon Lee S, You YK, Park JH, Kim HJ, Lee KK, Kim DG. Single-port transumbilical laparoscopic cholecystectomy: a preliminary study in 37 patients with gallbladder disease. J Laparoendosc Adv Surg Tech A. 2009 Aug;19(4):495-9. doi: 10.1089/lap.2008.0424.
- Rao PP, Bhagwat SM, Rane A, Rao PP. The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB (Oxford). 2008;10(5):336-40. doi: 10.1080/13651820802276622.
- Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25.
- MNT-2011