Status:
COMPLETED
Single Incision Laparoscopy
Lead Sponsor:
University of California, San Diego
Conditions:
Appendicitis
Cholelithiasis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00616616
Start Date
September 1 2007
End Date
February 1 2010
Last Update
October 26 2016
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92103