Single Incision Laparoscopy (SIL)

University of California San Diego

Status: Completed

Conditions: Appendicitis; Malignant Hypertension; Cholelithiasis

Treatments: Procedure: single incision laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00616616

071271

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Description:

all subjects

Treatment:

Procedure: single incision laparoscopic surgery