Assessment of a Modified Minimally Invasive Esophagectomy

Esophageal Cancer Clinical Trial

Official title:

Assessment of a Modified Minimally Invasive Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219410
• Other study ID #: 1279152-4
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: January 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• patient with primary esophageal cancer of any cell type

• underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons

Exclusion Criteria:

• non-elective procedure

• less than 90 days of post-discharge follow-up

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Procedure:
• Fully minimally invasive esophagectomy
Esophagectomy using a novel fully minimally invasive approach

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Hospital length of stay	Through study completion, an average of 2.9 years
Secondary	Intensive care unit length of stay	Intensive care unit length of stay	Through study completion, an average of 2.9 years
Secondary	Feeding tube placement	Feeding tube placement	Intra-operatively
Secondary	Number of patients with inpatient mortality	Number of patients with inpatient mortality	Through study completion, an average of 2.9 years
Secondary	90-day total mortality	90-day total mortality	90 days post discharge
Secondary	Number of patients with hospital readmission within 30 days	Number of patients with hospital readmission within 30 days	30 days post discharge
Secondary	Number of patients with complications	Number of patients with medical and surgical complications both inpatient and post-discharge	Hospital stay and 30 days post discharge