Safe Colorectal Surgery in the Elderly

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Proctectomy

• Registration Number: NCT03765411
• Lead Sponsor: Tripler Army Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2013-01-01
• Primary Completion: 2013-04-15
• Study Completion: 2017-04-15
• Study First Submitted: 2018-11-28
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6740

Inclusion Criteria

• 70 years of age or older
• underwent proctectomy

Exclusion Criteria

• emergent admissions
• abdominoperineal resections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic Proctectomy Patients	Proctectomy	Patients who underwent Proctectomy through a Robotic approach
Open Proctectomy Patients	Proctectomy	Patients who underwent Proctectomy through an open approach
Laparoscopic Proctectomy Patients	Proctectomy	Patients who underwent Proctectomy through a Laparoscopic approach

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	through study completion, an average of 5 days	Death during admission
Length of Stay	through study completion, an average of 5 days	Length of in hospital stay
Costs and Charges	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

Trial Locations

Locations (1)

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States