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Quality of Life After Esophagectomy for Cancer

NCT ID: NCT00798746

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-05-31

Brief Summary

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The purpose of the current study is to assess the role of pyloric drainage procedure on altering the reflux effect on the quality of life in patients who underwent esophagectomy. Researchers hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.

Detailed Description

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Surgery is considered curative for patients with esophageal cancer. The minimally invasive approach was developed such that laparoscopy and thoracoscopy replace large abdominal and thoracic incisions. For both open and minimally invasive procedures, patients have many adjustments to overcome in order to regain quality of life that is within the norm. In a recent study on the health-related quality of life (HRQL) after curative surgical resection, symptoms of reflux was the only variable that worsened with statistical significance.

The study plan is to retrospectively compare two groups of patients: those who underwent esophagectomy with pyloric drainage procedure and those who did not. The study will be done using all MD Anderson patients who underwent minimally invasive esophagectomies, in which pyloroplasty and pyloromyotomy are not standard procedures. Clinically relevant data and demographic information will be collected retrospectively for the two groups including age, gender, Body Mass Index, level of anastomosis, and time elapsed since surgery. All patients will be interviewed via telephone. At least two attempts will be made to contact each patient.

Conditions

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Esophageal Cancer

Keywords

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Esophageal cancer pyloric drainage pyloric drainage procedure reflux reflux symptoms esophagectomy Quality of Life Health-related quality of life HRQL

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pyloric Drainage Procedure

Esophagectomy with pyloric drainage procedure

Telephone Questionnaire

Intervention Type BEHAVIORAL

Ten questions regarding symptoms of reflux

No Pyloric Drainage Procedure

Esophagectomy without pyloric drainage procedure

Telephone Questionnaire

Intervention Type BEHAVIORAL

Ten questions regarding symptoms of reflux

Interventions

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Telephone Questionnaire

Ten questions regarding symptoms of reflux

Intervention Type BEHAVIORAL

Other Intervention Names

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Reflux Survey Gastrointestinal Symptoms Rating Scale GSRS Quality of life questionnaires Health-related quality of life HRQL

Eligibility Criteria

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Inclusion Criteria

1. patients who are 18 years-old or older
2. Patients who received esophagectomy indicated for primary esophageal cancer, either adenocarcinoma or squamous cell carcinoma
3. Patients who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy at MDACC during or after 2004
4. Patients who are English-speaking and of any ethnicity
5. Patients with prior cancers, any clinical stage of esophageal carcinoma, any performance status (as rated by American Society of Anesthesiologist Risk Scale), received or did not receive preoperative treatment, had level of anastomosis in either neck or chest

Exclusion Criteria

1\) Patients who received esophagectomies indicated for emergency, salvage or redo
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reza J. Mehran, MD

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

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UT MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

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2008-0465

Identifier Type: -

Identifier Source: org_study_id