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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University of California, San Diego

San Diego, California, United States, 92103