Gastroesophageal Reflux DiseaseNCT03848494
True Short Esophagus in Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease, run by University of Bologna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 31 Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by gastroesophageal reflux disease or hiatus hernia submitted to primary minimally invasive surgery.
Who may be able to join
- Patients submitted to primary minimally invasive surgery for gastroesophageal reflux diseases or hiatus hernia.
- Age > 18 years.
Who cannot join
- 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.
About this study
Official title: True Short Esophagus in Gastroesophageal Reflux Disease or Hiatus Hernia
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Surgery
- Keywords
- gastroesophageal reflux disease, hiatus hernia
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Laparoscopic floppy Nissen, laparoscopic-left thoracoscopic Collis-Nissen, laparoscopic gastric fundus wrapped around the stomach
| Study group | Role | What they receive |
|---|---|---|
| Gastroesophageal reflux disease | Patients submitted to primary minimally invasive surgery for gastroesophageal reflux disease or hiatus hernia Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of true short esophagus
Intraoperative abdominal esophageal length < 1.5 cm
Measured: 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.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2004
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
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
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marialuisa Lugaresi, University of Bologna
- Investigators
- Marialuisa Lugaresi, MD, PhD, Principal investigator, Department of Medical and Surgical Sciences University of Bologna Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848494
- Sponsor's protocol ID
- True Short Esophagus-2019
- Status last verified
- Feb 2019
- First submitted
- 23 Jan 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- True Short Esophagus in Gastroesophageal Reflux Disease or Hiatus Hernia
- ClinicalTrials.gov ID
- NCT03848494
- Acronym / sponsor ID
- True Short Esophagus-2019
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- gastroesophageal reflux disease, hiatus hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal reflux disease | – | Procedure: SurgeryPatients submitted to primary minimally invasive surgery for gastroesophageal reflux disease or hiatus hernia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by gastroesophageal reflux disease or hiatus hernia submitted to primary minimally invasive surgery.
Key inclusion criteria (2 listed)
- Patients submitted to primary minimally invasive surgery for gastroesophageal reflux diseases or hiatus hernia.
- Age > 18 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryLaparoscopic floppy Nissen, laparoscopic-left thoracoscopic Collis-Nissen, laparoscopic gastric fundus wrapped around the stomach | Procedure or surgery | Gastroesophageal reflux disease |
Primary outcome
Frequency of true short esophagus
Time frame: 9 years
Intraoperative abdominal esophageal length < 1.5 cm
Long term results after surgery
Time frame: 9 years
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.
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 20 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Marialuisa Lugaresi, MD, PhD principal investigator
Department of Medical and Surgical Sciences University of Bologna Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by University of Bologna.
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 2 inclusion and 4 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Frequency of true short esophagus (time frame: 9 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 20 Feb 2019.