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A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy (MC-UsD)

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ClinicalTrials.gov Identifier: NCT01723540
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Sponsor:
Information provided by (Responsible Party):
Kuopio University Hospital

Brief Summary:
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Minilaparotomy vs laparoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.
Study Start Date : September 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Minilaparotomy cholecystectomy with ultrasonic scissors
Minilaparotomy vs laparoscopy
Procedure: Minilaparotomy vs laparoscopy
MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy

Active Comparator: Laparoscopic cholecystectomy
Minilaparotomy vs laparoscopy
Procedure: Minilaparotomy vs laparoscopy
MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy




Primary Outcome Measures :
  1. Early recovery [ Time Frame: One month ]
    Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery


Secondary Outcome Measures :
  1. Peroperative outcome [ Time Frame: 24 hours ]
    Operative time, time at the operation theatre, bleeding, length of skin incision



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud

  • ASA physical status 1-3
  • Body mass index 18-30
  • AGE 18 - 75 years

Exclusion Criteria:

  • Pregnancy or lactating
  • common bile-duct stones
  • acute cholecystitis
  • previous upper abdominal operation
  • Chirrosis
  • Renal disease
  • Pancreatitis
  • ASA 4-5
  • Participation of any other clinical trial within 30 days before the start of the screening period
  • History of uncontrolled cardiovascular, epileptic disorder, psychosis.

Information from the National Library of Medicine

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): NCT01723540


Locations
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Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
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Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01723540    
Other Study ID Numbers: KUH5204520
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012
Keywords provided by Kuopio University Hospital:
Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations