Status:
COMPLETED
Melatonin Treatment After Laparoscopic Cholecystectomy
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Postoperative Complications
Fatigue
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and...
Detailed Description
Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after su...
Eligibility Criteria
Inclusion
- Operation for gall bladder disease
- Age over 18 years
Exclusion
- Known preoperative sleep disturbance
- Anticoagulant therapy
- Psychiatric disease
- Lack of written informed consent
- Treatment with hypnotics within one week prior to surgery
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00113906
Start Date
March 1 2005
End Date
August 1 2006
Last Update
February 11 2014
Active Locations (2)
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1
University Hospital of Glostrup
Glostrup Municipality, Copenhagen, Denmark, 2900
2
Copenhagen University Hospital, Gentofte
Hellerup, Copenhagen, Denmark, 2900