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Single Incision Laparoscopy (SIL)

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ClinicalTrials.gov Identifier: NCT00616616
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : October 26, 2016
Sponsor:
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

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

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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00616616


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

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00616616     History of Changes
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:
appendectomy
cholecystectomy
gastric banding
adrenalectomy
Gastric lap-band placement

Additional relevant MeSH terms:
Appendicitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Hypertension, Malignant
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Hypertension
Vascular Diseases
Cardiovascular Diseases