Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00798746 |
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. We hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.
Condition | Intervention |
---|---|
Esophageal Cancer |
Behavioral: Telephone Questionnaire |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Role of Pyloric Drainage in Reflux Symptoms After Esophagectomy for Cancer. |
Estimated Enrollment: | 90 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
Esophagectomy with pyloric drainage procedure.
|
Behavioral: Telephone Questionnaire
Ten questions regarding symptoms of reflux
|
2
Esophagectomy without pyloric drainage procedure.
|
Behavioral: Telephone Questionnaire
Ten questions regarding symptoms of reflux
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adults who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy for primary esophageal cancer at MDACC during or after 2004.
Inclusion Criteria:
Exclusion Criteria:
1) Patients who received esophagectomies indicated for emergency, salvage or redo
Contact: Reza J. Mehran, MD | 713-794-1477 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Reza J. Mehran, MD 713-794-1477 | |
Principal Investigator: Reza J. Mehran, MD |
Principal Investigator: | Reza J. Mehran, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Reza J. Mehran, MD/Professor ) |
Study ID Numbers: | 2008-0465 |
Study First Received: | November 25, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00798746 |
Health Authority: | United States: Institutional Review Board |
Esophageal cancer pyloric drainage pyloric drainage procedure reflux reflux symptoms |
esophagectomy Quality of Life Health-related quality of life HRQL |
Digestive System Neoplasms Digestive System Diseases Esophageal disorder Gastrointestinal Diseases Head and Neck Neoplasms |
Esophageal Neoplasms Quality of Life Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
Neoplasms Neoplasms by Site |