TerminatedInterventionalNot ApplicableUpdated Aug 22, 2014
Single Incision Laparoscopy | NCT00616616 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 26, 2016
Single Incision Laparoscopy
Single Incision Laparoscopy
ClinicalTrials.gov ID
NCT00616616
Lead Sponsor
University of California, San DiegoOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
24Actual
Last Update Posted
Oct 26, 2016Estimated
Start Date
Sep 2007
Primary Completion Date
Jul 2009Actual
Completion Date
Feb 2010Actual
Official Title
Single Incision Laparoscopy
Brief Summary
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).
Appendicitis
Cholelithiasis
Malignant Hypertension
single incision laparoscopic surgery
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-75
Patient has consented for a laparoscopic operation (independent of study participation)
Attending surgeon decides operation can be completed via a single incision laparoscopic approach
Exclusion Criteria:
Patients with BMI greater than 40
Minors and cognitively impaired individuals
Patients who are ASA class IV - Illness that is a constant threat to life
Patients with ascites or Child's class C of liver failure
Patients with known common bile duct stones
Patients with coagulopathy, abnormal coagulation studies, or who take heparin, coumadin, Plavix (clopidogrel), aspirin, or other medication for the purpose of anti-coagulation and cannot be removed from the medication prior to the operation.
Patients who present with incarcerated (irreducible) or strangulated hernias
Patients with preoperative hematocrits less than 25.
Preoperative hematocrit less than 25.
Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
Heart rate greater than 130 or less than 50. Respiratory rate greater than 35 or less than 6. Patients who are on continuous pressor drip for blood pressure support.
Patients who present for emergency adrenalectomy.
Patients with CT scan evidence of an abdominal abscess.
Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)