Clinical trial NCT03848494: True Short Esophagus in Gastroesophageal Reflux Disease
Official title: True Short Esophagus in Gastroesophageal Reflux Disease or Hiatus Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: gastroesophageal reflux disease
hiatus hernia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by gastroesophageal reflux disease or hiatus hernia submitted to primary minimally invasive surgery.

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.

Detailed description: In the 1960s, surgery for hiatus hernia and gastroesophageal reflux disease were introduced based on anatomical principles. The technical foundations of the new surgery were essentially dictated by experience. The following findings were reported: the stomach must be wrapped around an adequate segment of intra-abdominal esophagus, the antireflux barrier is efficient if the fundoplication acts under abdominal pressure and tension over sutures must be minimal to avoid disruption. Since the early use of open antireflux surgery, controversy has arisen between surgeons who treat patients using dedicated techniques in cases diagnosed with a shortened esophagus and surgeons who deny the existence of short esophagus. The clinical results achieved by both parties were not different, independently of the adoption of an open or minimally invasive technique. In 2008, a multicenter study found that true short esophagus was present in almost 20% of patients who were routinely submitted to surgery for gastroesophageal reflux disease and/or not axial hiatus hernias; the study was based on intraoperative measurements obtained in centimeters of the distance between the gastric folds considered the gastroesophageal junction and the apex of the diaphragm after extensive mobilization of the intra thoracic esophagus. Recently, in a study performed to assess symptomatic recurrence in patients who underwent laparoscopic repair of large hernias, the authors did not perform any esophageal lengthening procedures because an adequate segment of abdominal esophagus was always achieved after extended esophageal mobilization; they concluded that the use of proton pump inhibitors for the medical management of gastroesophageal reflux disease may have reduced the formation of peptic stricture, which is associated with short esophagus, and that esophageal lengthening procedures should probably no longer be applied.

In this study, the position of the gastroesophageal junction with respect for the diaphragmatic hiatus was assessed subjectively. Once more, crucial questions related to the debate on short esophagus were raised: is it possible that a) without an objective assessment of the position of the gastroesophageal junction , the gastric fundus may be inadvertently wrapped around the hypo cardia stomach, which acquires a tubular shape as a consequence of progressive esophageal shortening; and b) can the unconventional stomach around stomach fundoplication approach achieve good clinical results? To answer these questions, the investigators considered cases operated upon to gastroesophageal reflux disease and hiatus hernia since 2004, when was routinely adopted the use of intraoperative endoscopic assessment of the gastroesophageal junction position with respect for the diaphragmatic hiatus, were considered. In this series, participants were grouped according to the radiological classification of hiatus hernia, the length of the intra-abdominal esophagus, the surgical techniques adopted.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Frequency of true short esophagus
timeFrame: 9 years
measure: Long term results after surgery
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical and Surgical Sciences University of Bologna Italy
name: Marialuisa Lugaresi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: