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OpenTrials
Completed

NCT Number: NCT00616616

Single Incision Laparoscopy

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

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

single incision laparoscopic surgery

Procedure

Surgery will be performed with ine laparoscopic incision

Primary outcomes

  1. Evaluate the safety and efficacy of single incision laparoscopy

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: SIL

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Feb 15, 2008
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.