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Single Incision Laparoscopy (SIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616616
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego

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

Condition or disease Intervention/treatment Phase
Appendicitis Cholelithiasis Malignant Hypertension Procedure: single incision laparoscopic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopy
Study Start Date : September 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
all subjects
Procedure: single incision laparoscopic surgery
Surgery will be performed with ine laparoscopic incision

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616616

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

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Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego Identifier: NCT00616616    
Other Study ID Numbers: 071271
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Santiago Horgan, University of California, San Diego:
gastric banding
Gastric lap-band placement
Additional relevant MeSH terms:
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Hypertension, Malignant
Vascular Diseases
Cardiovascular Diseases
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Biliary Tract Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical