NCT00616616

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

February 4, 2008

Last Update Submit

October 24, 2016

Conditions

AppendicitisCholelithiasisMalignant Hypertension

Keywords

appendectomycholecystectomygastric bandingadrenalectomyGastric lap-band placement

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety and efficacy of single incision laparoscopy

    1 month

Study Arms (1)

1

EXPERIMENTAL

all subjects

Procedure: single incision laparoscopic surgery

Interventions

single incision laparoscopic surgeryPROCEDURE

Surgery will be performed with ine laparoscopic incision

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

AppendicitisCholelithiasisHypertension, Malignant

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesBiliary Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Santiago Horgan, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

September 1, 2007

Primary Completion

July 1, 2009

Study Completion

February 1, 2010

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

US(1)