NCT01723540

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

November 6, 2012

Last Update Submit

November 6, 2012

Conditions

Postoperative Pain

Keywords

Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Peroperative outcome

    24 hours

Study Arms (2)

Minilaparotomy cholecystectomy with ultrasonic scissors

EXPERIMENTAL

Minilaparotomy vs laparoscopy

Procedure: Minilaparotomy vs laparoscopy

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

Minilaparotomy vs laparoscopy

Procedure: Minilaparotomy vs laparoscopy

Interventions

Minilaparotomy vs laparoscopyPROCEDURE

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

Laparoscopic cholecystectomyMinilaparotomy cholecystectomy with ultrasonic scissors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 8, 2012

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 8, 2012

Record last verified: 2012-11

Locations

FI(1)