Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
NCT ID: NCT01348620
Last Updated: 2011-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
58 participants
INTERVENTIONAL
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy
NCT01094379
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
NCT01268748
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
NCT01824186
A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
NCT00892879
Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
NCT06375057
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single port laparoscopic 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)
Four-port laparoscopic device
Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Four port laparoscopic cholecystectomy surgery
Four port laparoscopic cholecystectomy surgery
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Biliary dyskinesia
* Gallbladder polyps
* Other diagnosis at the discretion of the surgeon
Exclusion Criteria
* Jaundice
* Choledocolithiasis
* History of Pancreatitis
* Severe comorbidity
* BMI \> 30
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sacro Cuore Don Calabria General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sacro Cuore - Don Calabria Hospital
Negrar, Verona, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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. doi: 10.3748/wjg.v16.i2.270.
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.
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.
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.
Partelli S, Barugola G, Sartori A, Crippa S, Falconi M, Ruffo G. Single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy performed by a single surgeon: findings of a randomized trial. Surg Today. 2016 Mar;46(3):313-8. doi: 10.1007/s00595-015-1182-7. Epub 2015 Jun 3.
Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MNT-2011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.