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Single Incision Laparoscopy (SIL)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00616616
First received: February 4, 2008
Last updated: August 27, 2010
Last verified: August 2010
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopy

Resource links provided by NLM:


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: 1 month ] [ Designated as safety issue: Yes ]

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

  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
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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Santiago Horgan, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00616616     History of Changes
Other Study ID Numbers: 071271
Study First Received: February 4, 2008
Last Updated: August 27, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014