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OpenTrials
Completed

NCT Number: NCT00798746

Quality of Life After Esophagectomy for Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who are 18 years-old or older
  • Patients who received esophagectomy indicated for primary esophageal cancer, either adenocarcinoma or squamous cell carcinoma
  • Patients who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy at MDACC during or after 2004
  • Patients who are English-speaking and of any ethnicity
  • 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

  • Patients who received esophagectomies indicated for emergency, salvage or redo

Treatment and study plan

Telephone Questionnaire

Behavioral

Ten questions regarding symptoms of reflux

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

Primary outcomes

  1. Reflux Symptoms: Open Esophagectomy versus Minimally Invasive

    Time frame: Survey response collected at single point in time.

    Comparison of reflux symptoms in patients who underwent open esophagectomies with pyloric drainage and those who received minimally invasive esophagectomies without pyloric drainage. The survey consisted of ten questions regarding symptoms associated with reflux using Gastrointestinal Symptoms Rating Scale (GSRS). Responses to degree of reflux distress rated on a six-point scale for questions with "0" indicating no heartburn symptoms and "5" indicating most symptoms experienced.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2008
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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