Single Incision Laparoscopy (SIL)
Primary Purpose
Appendicitis, Cholelithiasis, Malignant Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
single incision laparoscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring appendectomy, cholecystectomy, gastric banding, adrenalectomy, Gastric lap-band placement
Eligibility Criteria
Inclusion Criteria:
- Ages 18-75
- Patient has consented for a laparoscopic operation (independent of study participation)
- Attending surgeon decides operation can be completed via a single incision laparoscopic approach
Exclusion Criteria:
- Patients with BMI greater than 40
- Minors and cognitively impaired individuals
- Patients who are ASA class IV - Illness that is a constant threat to life
- Patients with ascites or Child's class C of liver failure
- Patients with known common bile duct stones
- 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.
- Patients who present with incarcerated (irreducible) or strangulated hernias
- Patients with preoperative hematocrits less than 25.
- Preoperative hematocrit less than 25.
- Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
- 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.
- Patients who present for emergency adrenalectomy.
- Patients with CT scan evidence of an abdominal abscess.
- Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
all subjects
Outcomes
Primary Outcome Measures
Evaluate the safety and efficacy of single incision laparoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT00616616
First Posted
February 4, 2008
Last Updated
October 24, 2016
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00616616
Brief Title
Single Incision Laparoscopy
Acronym
SIL
Official Title
Single Incision Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Cholelithiasis, Malignant Hypertension
Keywords
appendectomy, cholecystectomy, gastric banding, adrenalectomy, Gastric lap-band placement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
all subjects
Intervention Type
Procedure
Intervention Name(s)
single incision laparoscopic surgery
Intervention Description
Surgery will be performed with ine laparoscopic incision
Primary Outcome Measure Information:
Title
Evaluate the safety and efficacy of single incision laparoscopy
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-75
Patient has consented for a laparoscopic operation (independent of study participation)
Attending surgeon decides operation can be completed via a single incision laparoscopic approach
Exclusion Criteria:
Patients with BMI greater than 40
Minors and cognitively impaired individuals
Patients who are ASA class IV - Illness that is a constant threat to life
Patients with ascites or Child's class C of liver failure
Patients with known common bile duct stones
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.
Patients who present with incarcerated (irreducible) or strangulated hernias
Patients with preoperative hematocrits less than 25.
Preoperative hematocrit less than 25.
Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
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.
Patients who present for emergency adrenalectomy.
Patients with CT scan evidence of an abdominal abscess.
Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Horgan, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single Incision Laparoscopy
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