Safe Colorectal Surgery in the Elderly

December 4, 2018 updated by: Carly R Richards, Tripler Army Medical Center

Safe Surgery in the Elderly: A Review of Outcomes Following Robotic Proctectomy From the Nationwide Inpatient Sample, a Retrospective Cross Sectional Cohort Study. Cross-Sectional Study

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach was compared for both primary and secondary outcomes.

Study Type

Observational

Enrollment (Actual)

6740

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
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center

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

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were eligible if they were 70 years old or greater, underwent proctectomy in an elective setting, and did not have an abdominoperioneal resection.

Description

Inclusion Criteria:

  • 70 years of age or older
  • underwent proctectomy

Exclusion Criteria:

  • emergent admissions
  • abdominoperineal resections

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
Intervention / Treatment
Open Proctectomy Patients
Patients who underwent Proctectomy through an open approach
Procedure: Proctectomy
Resection of the rectum
Laparoscopic Proctectomy Patients
Patients who underwent Proctectomy through a Laparoscopic approach
Procedure: Proctectomy
Resection of the rectum
Robotic Proctectomy Patients
Patients who underwent Proctectomy through a Robotic approach
Procedure: Proctectomy
Resection of the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Complications
Time Frame: through study completion, an average of 5 days
Complications to include mechanical wound, infections, urinary, pulmonary, gastrointestinal, cardiovascular, systemic, surgical, and any complication
through study completion, an average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: through study completion, an average of 5 days
Death during admission
through study completion, an average of 5 days
Length of Stay
Time Frame: through study completion, an average of 5 days
Length of in hospital stay
through study completion, an average of 5 days
Costs and Charges
Time Frame: through study completion, an average of 5 days
Hospital charges refer to the total amount billed by the hospital. Hospital cost refers to the amount paid by the insurance provider
through study completion, an average of 5 days

Collaborators and Investigators

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

Sponsor

Tripler Army Medical Center

Collaborators

Madigan Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

April 15, 2013

Study Completion (ACTUAL)

April 15, 2017

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (ACTUAL)

December 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Robotic Proct in the Elderly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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