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Completed

NCT Number: NCT01723540

A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70211, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minilaparotomy vs laparoscopy

Procedure

MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy

Primary outcomes

  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 outcomes

  1. Peroperative outcome

    Time frame: 24 hours

    Operative time, time at the operation theatre, bleeding, length of skin incision

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Acronym: MC-UsD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2012
Registry last updated
Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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