True Short Esophagus in Gastroesophageal Reflux Disease

NCT03848494 | Completed

• 1 other identifier: True Short Esophagus-2019
• Study Type: observational
• Target: 311
• Locations: 0 countries
• Sites: N/A

Brief Summary

True short esophagus is controversial in surgery for gastroesophageal reflux disease and hiatus hernia. Recently, it was published that extensive esophageal mobilization achieved an esophageal length adequate to perform around the esophagus fundoplication in all cases with satisfactory long-term results.

Conditions

Gastroesophageal Reflux Disease

Keywords

gastroesophageal reflux disease; hiatus hernia

Outcome Measures

Primary Outcomes (2)

• Frequency of true short esophagus

  Intraoperative abdominal esophageal length \< 1.5 cm

  9 years

• Long term results after surgery

  Excellent = no reflux symptoms or dysphagia or esophagitis; good = slight reflux symptoms or dysphagia on a monthly basis and no esophagitis; fair = moderate reflux symptoms or dysphagia on a weekly basis; grade A esophagitis according to Los Angeles classification; poor = severe reflux symptoms or dysphagia on a daily basis and esophagitis B,C,D according to Los Angeles classification.

  9 years

Study Arms (1)

Gastroesophageal reflux disease

Patients submitted to primary minimally invasive surgery for gastroesophageal reflux disease or hiatus hernia

Procedure: Surgery

Interventions

Surgery PROCEDURE

Laparoscopic floppy Nissen, laparoscopic-left thoracoscopic Collis-Nissen, laparoscopic gastric fundus wrapped around the stomach

Gastroesophageal reflux disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by gastroesophageal reflux disease or hiatus hernia submitted to primary minimally invasive surgery.

You may qualify if:

• Patients submitted to primary minimally invasive surgery for gastroesophageal reflux diseases or hiatus hernia.
• Age \> 18 years.

You may not qualify if:

• Patients already submitted to minimally invasive surgery for gastroesophageal reflux diseases or hiatus hernia for recurrence of the disease.
• Patients submitted to open surgery for gastroesophageal reflux diseases or hiatus hernia.
• Patients affected by other esophageal diseases.
• Age \< 18 years.

Sponsors & Collaborators

• University of Bologna: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Marialuisa Lugaresi, MD, PhD

  Department of Medical and Surgical Sciences University of Bologna Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor MD, PhD

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 20, 2019
• Study Start: January 1, 2004
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share