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Single Incision Laparoscopy (SIL)

This study has been completed.
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego Identifier:
First received: February 4, 2008
Last updated: October 24, 2016
Last verified: October 2016
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).

Condition Intervention
Appendicitis Cholelithiasis Malignant Hypertension Procedure: single incision laparoscopic surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopy

Further study details as provided by Santiago Horgan, University of California, San Diego:

Primary Outcome Measures:
  • Evaluate the safety and efficacy of single incision laparoscopy [ Time Frame: 1 month ]

Enrollment: 24
Study Start Date: September 2007
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
all subjects
Procedure: single incision laparoscopic surgery
Surgery will be performed with ine laparoscopic incision


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Ages 18-75
  2. Patient has consented for a laparoscopic operation (independent of study participation)
  3. Attending surgeon decides operation can be completed via a single incision laparoscopic approach

Exclusion Criteria:

  1. Patients with BMI greater than 40
  2. Minors and cognitively impaired individuals
  3. Patients who are ASA class IV - Illness that is a constant threat to life
  4. Patients with ascites or Child's class C of liver failure
  5. Patients with known common bile duct stones
  6. 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.
  7. Patients who present with incarcerated (irreducible) or strangulated hernias
  8. Patients with preoperative hematocrits less than 25.
  9. Preoperative hematocrit less than 25.
  10. Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
  11. 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.
  12. Patients who present for emergency adrenalectomy.
  13. Patients with CT scan evidence of an abdominal abscess.
  14. Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00616616

United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Santiago Horgan, MD University of California, San Diego
  More Information

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego Identifier: NCT00616616     History of Changes
Other Study ID Numbers: 071271
Study First Received: February 4, 2008
Last Updated: October 24, 2016

Keywords provided by Santiago Horgan, University of California, San Diego:
gastric banding
Gastric lap-band placement

Additional relevant MeSH terms:
Hypertension, Malignant
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Biliary Tract Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases processed this record on August 16, 2017