Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
NCT ID: NCT01268748
Last Updated: 2010-12-31
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
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2010-09-30
2012-06-30
Brief Summary
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Detailed Description
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Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.
Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.
Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.
Cosmesis is evaluated after 28 days.
Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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4 ports laparoscopic cholecystectomy
Conventional laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
One port transumb. laparoscopic surgery
Experimental laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
Interventions
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Conventional laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
Experimental laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis
Exclusion Criteria
* History of cholecystitis or severe pancreatitis
* Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery
18 Years
75 Years
FEMALE
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
University of Copenhagen
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Dept. of Surgery K, Bispebjerg Hospital, University of Copenhagen, DK-2400 Copenhagen NV, Denmark
Principal Investigators
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Haytham Al-Tayar, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen
Sami Assaadzadeh, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Surgery, Gentofte Hospital, University of Copenhagen
Jacob Rosenberg, MD, DrMSc
Role: PRINCIPAL_INVESTIGATOR
Dept. of Surgery, Herlev Hospital, University of Copenhagen
Flemming Hjørne, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Surgery, Køge Hospital, University of Copenhagen
Thue Bisgaard, MD, DrMSc
Role: PRINCIPAL_INVESTIGATOR
Dept. of Surgery, Køge Hospital, University of Copenhagen
Locations
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Dept. of Surgery K, Bispebjerg Hospital
Copenhagen NV, , Denmark
Gentofte Hospital, University of Copenhagen
Gentofte Municipality, , Denmark
Dept. of Surgery, Koege Hospital, University of Copenhagen
Koege, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Lars N Jorgensen, MD, DrMSc
Role: primary
Jacob Rosenberg, MD, DrMSc
Role: primary
Thue Bisgaard, MD, DrMSc
Role: primary
References
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Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.
Other Identifiers
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H-3-2010-064
Identifier Type: -
Identifier Source: org_study_id