CompletedNot Applicable

Single Incision Laparoscopy

United States24 participantsStarted 2007-09

Plain-language summary

Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Evaluate the safety and efficacy of single incision laparoscopy

Timeframe: 1 month

NCT IDNCT00616616

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07