A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy

Postoperative Pain Clinical Trial

— MC-UsD  

Official title:

A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723540
• Other study ID #: KUH5204520
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: November 6, 2012
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2012
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Research Ethics Committee, Hospital District of Northern Savo
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early recovery	Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery	One month	No
Secondary	Peroperative outcome	Operative time, time at the operation theatre, bleeding, length of skin incision	24 hours	No