Gastroesophageal Reflux Disease Clinical Trial
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.
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.
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.
1. 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
2. The clinical-instrumental predictors of esophageal elastic or fibrotic shortening are
not defined and current studies adopt different evaluation criteria
3. The perception of "excessive tension" of the fundoplication at the operating table is
highly subjective.
4. 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
1. 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
2. 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;
3. To define the preoperative clinical and instrumental predictors for a surgical procedure
aimed to treat foreshortened esophagus;
4. To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures
adopted for the surgical treatment of GERD;
;
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