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Clinical Trials/NL-OMON40838
NL-OMON40838
Recruiting
Phase 4

A phase IV, blinded, randomized controlled trial to compare the effectiveness of low pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize the quality-of-recovery during the early post-operative phase - LEOPARD-2 study

niversitair Medisch Centrum Sint Radboud0 sites64 target enrollmentTBD
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Conditionsdonor nephrectomykidney donation1003843010038365

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
donor nephrectomy
Sponsor
niversitair Medisch Centrum Sint Radboud
Enrollment
64
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

Inclusion Criteria

  • •Obtained informed consent
  • •Age over 18 years

Exclusion Criteria

  • •insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
  • •chronic use of analgetics or psychotropic drugs
  • •use of NSAIDs shorter than 5 days before surgery
  • •known of suspect allergy to rocuronium or sugammadex
  • •significant liver\* or renal\*\* dysfunction
  • •neuromuscular disease
  • •pregnant of breastfeeding;\*Liver dysfunction is defined as alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \> twice the upper limit (extremely rare in live kidney donors)
  • •\*\* renal dysfunction is defined as serum creatinine twice the normal level and/or glomerular filtration rate \< 60 ml/min (extremely rare in live kidney donors)

Outcomes

Primary Outcomes

Not specified

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