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Single Incision Laparoscopy (SIL)
This study is currently recruiting participants.
Verified by University of California, San Diego, February 2008
Sponsored by: University of California, San Diego
Information provided by: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00616616
  Purpose

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

MedlinePlus related topics: Appendicitis Gallstones High Blood Pressure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Single Incision Laparoscopy

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

Primary Outcome Measures:
  • Evaluate the safety and efficacy of single incision laparoscopy [ Time Frame: continuos ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2007
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
all subjects
Procedure: single incision laparoscopic surgery
Surgery will be performed with ine laparoscopic incision

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616616

Contacts
Contact: Julie Bosia, BSN 619-471-0447 misresearch@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Julie Bosia, BSN     619-471-0447     misresearch@ucsd.edu    
Principal Investigator: Santiago Horgan, MD            
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, MD University of California, San Diego
  More Information

Responsible Party: University of California, San Diego ( Santiago Horgan, MD )
Study ID Numbers: 071271
Study First Received: February 4, 2008
Last Updated: February 14, 2008
ClinicalTrials.gov Identifier: NCT00616616  
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
appendectomy
cholecystectomy
gastric banding
adrenalectomy
Gastric lap-band placement

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Cholecystolithiasis
Gallbladder Diseases
Cholelithiasis
Gallstones
Gastrointestinal Diseases
Vascular Diseases
Intestinal Diseases
Calculi
Hypertension, Malignant
Digestive System Diseases
Appendicitis
Biliary Tract Diseases
Gastroenteritis
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Cecal Diseases

ClinicalTrials.gov processed this record on January 14, 2009