Gastroesophageal Reflux DiseaseGERDSurgeryNCT00507377
Foreshortened Esophagus and Its Surgical Therapy
An observational study of Gastroesophageal Reflux Disease and Hiatal Hernia, run by University of Bologna at 8 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia
- How many people
- 180 participants
- Where
- 8 sitesItaly
- Study dates
- Sep 2005to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GERD patients > 18 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Dept. of "Surgery, Intensive Care and Organs Transplantation"
Bologna, 40138
Department of General and Minimally Invasive Surgery -- Esophago-gastric Surgery Unit, Istituto Clinico Humanitas, Rozzano, University of Milan
Milan, 20089
First Division of General and Gastrointestinal Surgery, Second University of Naples
Naples, 80131
Unit of Gastrointestinal Surgery, School of Medicine, II University of Naples
Naples, 80135
VIII Division of General Surgery and Gastroenterologic Physiopathology, II University of Naples
Naples, 80138
Department of Medical and Surgical Sciences Clinica Chirurgica 3, University of Padova
Padua, 35128
General Surgery IV, Regional Referral Center for Esophageal Pathology, Department of Medical and Surgical Gastroenterology, AOU Pisana, Pisa
Pisa, 56126
Department of Surgery, Minimally Invasive Surgery Center, University of Turin
Turin, 10126
About this study
Official title: Frequency, Predictors, Intraoperative Assessment and Outcome of Foreshortened Esophagus and Its Surgical Therapy in Patients Treated for Gastro-Esophageal Reflux Disease (GERD)
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.
Read more
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.
Read the detailed description
INTRODUCTION The existence, diagnosis and treatment of short esophagus is one of the controversies of the past within esophageal surgery which has recently re-emerged. This entity was described in detail by radiologists in the 60's. Many surgeons confirmed its existence in the operating room, describing the clinical, anatomical and surgical patterns along with the modalities of surgical treatment of shortened esophagus following progressive fibrosis and retraction of the esophageal wall consequent to severe long standing gastro-esophageal reflux disease (GERD). Contrarily other surgeons denied its existence claiming that the gastro-oesophageal junction can be reduced into the abdomen without tension in virtually all patients and that the esophagus is, in fact, not shortened. In the case series of open antireflux surgery, the percentage of dedicated procedures aimed to treat the condition of non-reducibility of the gastro-esophageal junction (GEJ) below the diaphragm is highly variable.
In the present era of minimally invasive antireflux surgery, short esophagus again seems to originate controversy and open debate. Many thousands of laparoscopic standard antireflux operations have been performed in the world and numerous articles report satisfactory short and medium-term functional results in over 90% of cases, although in these experiences the need for a tailored approach has not emerged. However, in the last two or three years, many reports on the diagnosis and laparoscopic management of shortened esophagus in GERD surgery have been published.
The controversy is based on four facts.
- If the indications for surgical therapy of GERD are restricted to severe, long standing cardial incontinence and to the complications associated with a hiatus hernia, then the number of patients with panmural esophagitis and esophageal shortening will be higher in percentage than if the indications are open also to refluxers otherwise treatable with intermittent low dosage medical therapy
- The clinical-instrumental predictors of esophageal elastic or fibrotic shortening are not defined and current studies adopt different evaluation criteria
- The perception of "excessive tension" of the fundoplication at the operating table is highly subjective.
- During the process of progressive shortening of the esophagus, the portion of the fundus attracted above the diaphragm may take the appearance of a funnel hardly distinguishable from a thickened oesophagus. Therefore the gastric fundus may be erroneously wrapped around the herniated stomach.
Preoperative assessment of the length of the esophagus in order to decide which surgical technique to adopt is controversial. Yau et all. demonstrated that there is an association between esophageal shortening measured by standard manometry and postoperative para-esophageal herniation, but this increased risk is small. Predictors of the need for esophageal lengthening procedure are para-esophageal hernia, Barrett's esophagus and failed antireflux surgery. However no preoperative assessment can give information on the degree of elasticity or fibrosis of the esophagus.
Through laparoscopic surgery, by cranially distending the diaphragmatic hiatus the pneumoperitoneum may by artefact increase the length of the intra-abdominal esophagus, and the impossibility to manually palpate and feel the tension applied to the esophagus to bring the GEJ below the diaphragm may make it difficult to recognize a condition of shortened esophagus, more so if the experience of the surgeon is not adequate.
On the basis of a radiological classification used since the sixties, later validated with a radiological-manometric study it was demonstrated that the progressive orad migration of the GEJ is associated with an increasing severity of cardial incontinence and gastro-esophageal reflux.
Recent studies have shown that the permanent orad displacement of the GEJ across or above the diaphragm is not infrequent in patients affected by various grades of GERD and that it is present in 50% of patients undergoing antireflux surgery for severe, not otherwise manageable GERD. Up to 25% of patients may require a procedure of lengthening of the esophagus in order to place the fundoplication below the diaphragm without tension.
The missed diagnosis of short esophagus and the consequent inadequacy of treatment is one of the major causes of failure of antireflux surgery.
As the number of antireflux operations, mainly laparoscopic, performed per year has remarkably increased, the issue of the so-called short esophagus is today one of the major points in the management of antireflux surgery, which deserves reappraisal and definitive clarification.
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, whether medical or surgical and to plan the best performance of the surgical procedure.
AIMS OF THE STUDY Principal aim
- 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. Secondary aims
- To define the percentage of surgical procedures aimed to treat electively a condition of non reducible, 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;
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- Esophageal Benign Disease, Gastroesophageal Reflux Disease, Hiatal Hernia, Antireflux Surgery, Short Esophagus
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startSep 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- The European Society of Esophagology
- Responsible party
- Principal investigator, Sandro Mattioli, University of Bologna
- Investigators
- Sandro Mattioli, MD, Study chair, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507377
- Sponsor's protocol ID
- 61657
- Acronym
- GERDSurgery
- Status last verified
- May 2018
- First submitted
- 25 Jul 2007
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency, Predictors, Intraoperative Assessment and Outcome of Foreshortened Esophagus and Its Surgical Therapy in Patients Treated for Gastro-Esophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00507377
- Acronym / sponsor ID
- GERDSurgery / 61657
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- Esophageal Benign Disease, Gastroesophageal Reflux Disease, Hiatal Hernia, Antireflux Surgery, Short Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- The European Society of Esophagology
- Study start
- Sep 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION The existence, diagnosis and treatment of short esophagus is one of the controversies of the past within esophageal surgery which has recently re-emerged. This entity was described in detail by radiologists in the 60's. Many surgeons confirmed its existence in the operating room, describing the clinical, anatomical and surgical patterns along with the modalities of surgical treatment of shortened esophagus following progressive fibrosis and retraction of the esophageal wall consequent to severe long standing gastro-esophageal reflux disease (GERD). Contrarily other surgeons denied its existence claiming that the gastro-oesophageal junction can be reduced into the abdomen without tension in virtually all patients and that the esophagus is, in fact, not shortened. In the case series of open antireflux surgery, the percentage of dedicated procedures aimed to treat the condition of non-reducibility of the gastro-esophageal junction (GEJ) below the diaphragm is highly variable.
In the present era of minimally invasive antireflux surgery, short esophagus again seems to originate controversy and open debate. Many thousands of laparoscopic standard antireflux operations have been performed in the world and numerous articles report satisfactory short and medium-term functional results in over 90% of cases, although in these experiences the need for a tailored approach has not emerged. However, in the last two or three years, many reports on the diagnosis and laparoscopic management of shortened esophagus in GERD surgery have been published.
The controversy is based on four facts.
- If the indications for surgical therapy of GERD are restricted to severe, long standing cardial incontinence and to the complications associated with a hiatus hernia, then the number of patients with panmural esophagitis and esophageal shortening will be higher in percentage than if the indications are open also to refluxers otherwise treatable with intermittent low dosage medical therapy
- The clinical-instrumental predictors of esophageal elastic or fibrotic shortening are not defined and current studies adopt different evaluation criteria
- The perception of "excessive tension" of the fundoplication at the operating table is highly subjective.
- During the process of progressive shortening of the esophagus, the portion of the fundus attracted above the diaphragm may take the appearance of a funnel hardly distinguishable from a thickened oesophagus. Therefore the gastric fundus may be erroneously wrapped around the herniated stomach.
Preoperative assessment of the length of the esophagus in order to decide which surgical technique to adopt is controversial. Yau et all. demonstrated that there is an association between esophageal shortening measured by standard manometry and postoperative para-esophageal herniation, but this increased risk is small. Predictors of the need for esophageal lengthening procedure are para-esophageal hernia, Barrett's esophagus and failed antireflux surgery. However no preoperative assessment can give information on the degree of elasticity or fibrosis of the esophagus.
Through laparoscopic surgery, by cranially distending the diaphragmatic hiatus the pneumoperitoneum may by artefact increase the length of the intra-abdominal esophagus, and the impossibility to manually palpate and feel the tension applied to the esophagus to bring the GEJ below the diaphragm may make it difficult to recognize a condition of shortened esophagus, more so if the experience of the surgeon is not adequate.
On the basis of a radiological classification used since the sixties, later validated with a radiological-manometric study it was demonstrated that the progressive orad migration of the GEJ is associated with an increasing severity of cardial incontinence and gastro-esophageal reflux.
Recent studies have shown that the permanent orad displacement of the GEJ across or above the diaphragm is not infrequent in patients affected by various grades of GERD and that it is present in 50% of patients undergoing antireflux surgery for severe, not otherwise manageable GERD. Up to 25% of patients may require a procedure of lengthening of the esophagus in order to place the fundoplication below the diaphragm without tension.
The missed diagnosis of short esophagus and the consequent inadequacy of treatment is one of the major causes of failure of antireflux surgery.
As the number of antireflux operations, mainly laparoscopic, performed per year has remarkably increased, the issue of the so-called short esophagus is today one of the major points in the management of antireflux surgery, which deserves reappraisal and definitive clarification.
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, whether medical or surgical and to plan the best performance of the surgical procedure.
AIMS OF THE STUDY Principal aim
- 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. Secondary aims
- To define the percentage of surgical procedures aimed to treat electively a condition of non reducible, 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;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GERD patients > 18 years
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Mattioli, MD study chair
University of Bologna
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Hiatal Hernia, run by University of Bologna at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.