Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy

April 15, 2016 updated by: Duke University
The purpose of this study is to compare the clinical outcomes and the operative costs of appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers. Prospective data will be collected before, during, and after surgery on patients undergoing a laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at Duke Regional Hospital. Retrospective data will be collected from patients who had an appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open appendectomy to compare outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke Center for Metabolic and Weight Loss Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients, aged 18 years of age or older, scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

Exclusion Criteria:

  1. Less than 18 years of age
  2. Signs of appendiceal rupture or abcess on preoperative imaging studies (CT or ultrasound)
  3. Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Polymetric clips
The study team will prospectively enroll subjects with a diagnosis of appendicitis who are scheduled for laparoscopic appendectomy to have Hem-o-Lok® clips used for closure of the appendiceal stump. All subjects enrolled in the study will have their medical chart reviewed from consent to 30 days post operatively.
Device: Polymetric clips
The study team will prospectively enroll subjects with a diagnosis of appendicitis who are scheduled for laparoscopic appendectomy to have Hem-o-Lok® clips used for closure of the appendiceal stump.
Endoscopic Staplers
The study team will retrospectively identify patients who have undergone laparoscopic appendectomy during a one year time span by performing a database search. The operative notes will be reviewed for these patients to select patients who underwent ligation of the appendix with an endoscopic stapler.
Other: Endoscopic Staplers
The study team will retrospectively identify patients who have undergone laparoscopic appendectomy by performing a database search. The operative notes will be reviewed for these patients to select patients who underwent ligation of the appendix with an endoscopic stapler.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Subjects will be followed for the duration of their hopsital stay, an expected average of 2-3 days.
Charts will be reviewed to calculate the number of days the subject was in the hospital. Clinical and financial outcomes of subjects enrolled for laparoscopic appendectomy using Hem-o-Lok will be compared to a historical (retrospective) cohort of patients who underwent appendectomy using endoscopic staplers.
Subjects will be followed for the duration of their hopsital stay, an expected average of 2-3 days.
Total Hospital Charges
Time Frame: Financial data will be gathered for the duration of the subjects hospital stay, an expected average of 2-3 days.
Data will be gathered on the expense of the subjects hospital stay from admission, surgery, to discharge. Clinical and financial outcomes of subjects enrolled for laparoscopic appendectomy using Hem-o-Lok will be compared to a historical (retrospective) cohort of patients who underwent appendectomy using endoscopic staplers.
Financial data will be gathered for the duration of the subjects hospital stay, an expected average of 2-3 days.
Operative time
Time Frame: Length of operation is approximately one and a half hours
Subject's chart will be reviewed to gather operative start and stop times. Clinical and financial outcomes of subjects enrolled for laparoscopic appendectomy using Hem-o-Lok will be compared to a historical (retrospective) cohort of patients who underwent appendectomy using endoscopic staplers.
Length of operation is approximately one and a half hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of Surgical Outcomes
Time Frame: Immediatly Postoperative to 30 days postoperative
Measures of surgical outcomes will be compared between the two procedures including rates of postoperative appendiceal stump dehiscence, hemorrhage, pneumonia, urinary tract infection, myocardial infarction, pulmonary embolism, deep vein thrombosis, and death.
Immediatly Postoperative to 30 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chan Park, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00041869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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