Foreshortened Esophagus and Its Surgical Therapy

NCT00507377 | Completed DMC

• 1 other identifier: 61657
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 8

Brief Summary

Background The existence, diagnosis and treatment of short esophagus is one of the controversies of the past which has recently re-emerged The missed diagnosis of short esophagus and the consequent inadequacy of treatment is one of the major causes of failure of antireflux surgery. The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could take advantage of the definition of frequency, preoperative predictors, intraoperative management and post operative outcomes of cases of foreshortened esophagus, in order to offer the patient affected by GERD the elements necessary for a conscious choice of therapy and to plan the best performance of the surgical procedure. Aims of the Study To define the percentage of cases among the total of antireflux procedures performed, in which, after standard isolation of the ge junction and eventual dissection of the mediastinal esophagus at least two centimetres of esophagus can not be replaced without any applied tension below the apex of the diaphragmatic hiatus. To define the percentage of surgical procedures aimed to treat electively a condition of non reducible G-E junction and foreshortened esophagus, among a multicentric formed case series of patients submitted to antireflux surgery. To define the preoperative clinical and instrumental predictors for a surgical procedure aimed to treat foreshortened esophagus. To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures adopted for the surgical treatment of GERD. Materials and Methods The study will comprise patients in which surgical therapy for GERD is indicated according to the international guidelines and the Centres policy . Patients will be submitted to the antireflux procedure chosen by the surgeon according to the internationally recognized scientific surgical principles and the personal judgement. The preoperative study and the postoperative follow up adopted in the present study are accepted by the Centres as they correspond to the international guidelines and the Centres' current practice criteria for the surgical treatment of GERD.

Conditions

Gastroesophageal Reflux Disease; Hiatal Hernia

Keywords

Esophageal Benign Disease; Gastroesophageal Reflux Disease; Hiatal Hernia; Antireflux Surgery; Short Esophagus

Eligibility Criteria

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

Study Population

GERD patients \> 18 years

You may qualify if:

• patients aged \> 18 years, undergoing surgery for the treatment of GERD, of massive incarcerated hiatus hernia ± GERD, in which a laparotomic, laparoscopic or thoracotomic approach is preoperatively indicated.

You may not qualify if:

• association of GERD with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders;
• redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach, on the diaphragm.

Sponsors & Collaborators

• University of Bologna: lead
• The European Society of Esophagology: collaborator

Study Sites (8)

Dept. of "Surgery, Intensive Care and Organs Transplantation"

Bologna, 40138, Italy

Location

Department of General and Minimally Invasive Surgery -- Esophago-gastric Surgery Unit, Istituto Clinico Humanitas, Rozzano, University of Milan

Milan, 20089, Italy

Location

First Division of General and Gastrointestinal Surgery, Second University of Naples

Naples, 80131, Italy

Location

Unit of Gastrointestinal Surgery, School of Medicine, II University of Naples

Naples, 80135, Italy

Location

VIII Division of General Surgery and Gastroenterologic Physiopathology, II University of Naples

Naples, 80138, Italy

Location

Department of Medical and Surgical Sciences Clinica Chirurgica 3, University of Padova

Padua, 35128, Italy

Location

General Surgery IV, Regional Referral Center for Esophageal Pathology, Department of Medical and Surgical Gastroenterology, AOU Pisana, Pisa

Pisa, 56126, Italy

Location

Department of Surgery, Minimally Invasive Surgery Center, University of Turin

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal

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

• Sandro Mattioli, MD

  University of Bologna

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: September 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

IT (8)