Single Incision Laparoscopy (SIL)
This study has been completed.
Sponsor:
University of California, San Diego
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
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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:
- 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)
Contacts and Locations
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 Cholelithiasis Cholecystolithiasis Gallstones Hypertension Hypertension, Malignant Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Biliary Tract Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013