Single Incision Laparoscopy

Appendicitis Clinical Trial

— SIL  

Official title:

Single Incision Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616616
• Other study ID #: 071271
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: October 24, 2016
• Start date: September 2007
• Est. completion date: February 2010

Study information

• Verified date: October 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Hypertension, Malignant
• Malignant Hypertension

Intervention

Procedure:
• single incision laparoscopic surgery
Surgery will be performed with ine laparoscopic incision

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and efficacy of single incision laparoscopy		1 month	Yes