Single Incision Laparoscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616616

Acronym

SIL

Enrollment

Registered

2008-02-15

Start date

2007-09-30

Completion date

2010-02-28

Last updated

2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Cholelithiasis, Malignant Hypertension

Keywords

appendectomy, cholecystectomy, gastric banding, adrenalectomy, Gastric lap-band placement

Brief summary

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

Interventions

PROCEDUREsingle incision laparoscopic surgery

Surgery will be performed with ine laparoscopic incision

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame
Evaluate the safety and efficacy of single incision laparoscopy	1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026