NCT00311259

Brief Summary

The purpose of this study is to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 5, 2006

Status Verified

February 1, 2006

First QC Date

April 3, 2006

Last Update Submit

April 3, 2006

Conditions

Oxidative StressInflammatory StressMyocardial Ischaemia

Interventions

Melatonin (drug)DRUG
LaktoseDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indikation for laparoscopic cholecystectomy
  • women between 18 and 70 years old

You may not qualify if:

  • men
  • acute cholecystectomy
  • pancreatitis
  • renal insufficient
  • well-known liver insufficient
  • cardiovascular disease (arrhythmia, well-known ischaemic heart disease)
  • drug therapy (digoxin, Ca-antagonist, amiodaron, beta-blocker)
  • anticoagulation therapy (marevan and marcoumar)
  • praeoperative therapy with opioid, anxiolytica and hypnotica)
  • well-known sleep disease
  • endocrine disease in drug therapy (diabetes mellitus, thyroid disease)
  • daily alcohol consumption (more than 5 drinks)
  • bad compliance (language difficulty, mental problems etc.)
  • pregnancy and breast-feeding
  • lack of written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Kucukakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7. doi: 10.1111/j.1399-6576.2010.02294.x.

    PMID: 20887414DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

MelatoninPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bülent Kücükakin

    Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bülent Kücükakin

CONTACT

+45 39978224bulkuc01@gentoftehosp.kbhamt.dk

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

May 1, 2006

Study Completion

November 1, 2006

Last Updated

April 5, 2006

Record last verified: 2006-02

Locations

DK(1)