Single Incision Laparoscopy

NCT ID: NCT00616616

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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Conditions

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Appendicitis Cholelithiasis Malignant Hypertension

Keywords

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appendectomy cholecystectomy gastric banding adrenalectomy Gastric lap-band placement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

all subjects

Group Type EXPERIMENTAL

single incision laparoscopic surgery

Intervention Type PROCEDURE

Surgery will be performed with ine laparoscopic incision

Interventions

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single incision laparoscopic surgery

Surgery will be performed with ine laparoscopic incision

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Santiago Horgan

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Santiago Horgan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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071271

Identifier Type: -

Identifier Source: org_study_id