Gastroesophageal Reflux Disease With Hiatal HerniaNCT01606449
Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia
An observational study of Gastroesophageal Reflux Disease With Hiatal Hernia and Paraesophageal Hernia, run by University of Bologna at 1 site in Italy.
Trial summary
Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroesophageal Reflux Disease With Hiatal Hernia, Paraesophageal Hernia
- What is being tested?
- Surgical Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1980to Jan 2012
- 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 consecutively operated upon for type II-IV hiatal hernia in the period January 1980-December 2010.
Who may be able to join
- patients aged > 18 years, undergoing surgery for the treatment of type II-IV hiatal hernia ± GERD.
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
1 site in 1 country.
Italy1 site
Department of General Surgery and Organ Transplantation
Bologna, 40138
About this study
Official title: Thirty-year Follow-up of a Case Series of Patients Operated Upon for Type II-IV Hiatal Hernia
Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. The real recurrence rates and the results of surgery for GERD are difficult to assess due to the lack of serial time points during the follow-up. Further bias may have been introduced into the analysis by a lack of appropriate controls. The results of surgical therapy for type II-IV HH are even more controversial because of the high rate of anatomical relapse and the different methods of follow-up adopted in reported case series.
Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The investigators report on patients who were followed up after surgery at various time points over the course of 30 years.
Read the detailed description
We reviewed the charts of patients who underwent primary surgery for type II-IV Hiatal Hernia during the period from January 1980 - December 2010.
Pre-operatively, the patients routinely underwent symptom assessment, a barium swallow, upper GI endoscopy and esophageal manometry.
The principles of surgery for GERD and hiatal hernias involve full isolation of the diaphragmatic pillars and E-G junction, full isolation and resection of the sac and fat pad into the mediastinum (except for the fat close to the lesser curvature, to preserve the integrity of the vagus nerves), evaluation of the degree of esophageal shortening, and a Collis gastroplasty in cases of short esophagi.
Post-operatively, the patients participated in a free-of-charge outpatient follow-up program at 6 months, 12 months and every year for 5 years.
The length of the follow-up was calculated from the day of the surgery to the day that the patient underwent the last complete follow-up. The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (from 0 = absence of symptoms and esophagitis to 3 = severe symptoms and esophagitis). An evaluation scale for the surgical results, with scores ranging from "excellent" to "poor", was also used.
- Being tested
- Surgical Therapy
- Keywords
- Gastroesophageal reflux diseases, Hiatal Hernia, Paraesophageal Hernia
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical TherapyProcedure or surgery
Open Anti-reflux fundoplication according to Nissen-Rossetti, floppy Nissen, Belsey MK IV,Collis Nissen, Collis-Belsey.
Minimally-Invasive fundoplication according to floppy Nissen, left thoracoscopic Collis-laparoscopic Nissen.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 = Patients with type II Hiatal Hernia submitted to surgical therapy Receives: Procedure: Surgical Therapy | |
| Group 2 | Group 2 = Patients with type III Hiatal Hernia submitted to surgical therapy Receives: Procedure: Surgical Therapy | |
| Group 3 | Group 3 = Patients with type IV Hiatal Hernia submitted to surgical therapy Receives: Procedure: Surgical Therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJan 1980
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease With Hiatal HerniaStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Mattioli, University of Bologna
- Investigators
- Sandro Mattioli, MD, Principal investigator, Department of General Surgery and Organ Transplantations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606449
- Sponsor's protocol ID
- UniBoDipTrap2
- Other IDs
- II-IV HH
- Status last verified
- Jan 2012
- First submitted
- 23 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lugaresi M, Mattioli B, Daddi N, Di Simone MP, Perrone O, Mattioli S. Surgery for Type III-IV hiatal hernia: anatomical recurrence and global results after elective treatment of short oesophagus with open and minimally invasive surgery. Eur J Cardiothorac Surg. 2016 Apr;49(4):1137-43. doi: 10.1093/ejcts/ezv280. Epub 2015 Sep 16.
PubMed 26377635
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirty-year Follow-up of a Case Series of Patients Operated Upon for Type II-IV Hiatal Hernia
- ClinicalTrials.gov ID
- NCT01606449
- Acronym / sponsor ID
- UniBoDipTrap2
- Keywords
- Gastroesophageal reflux diseases, Hiatal Hernia, Paraesophageal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 1980
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 May 2012 (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.
Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. The real recurrence rates and the results of surgery for GERD are difficult to assess due to the lack of serial time points during the follow-up. Further bias may have been introduced into the analysis by a lack of appropriate controls. The results of surgical therapy for type II-IV HH are even more controversial because of the high rate of anatomical relapse and the different methods of follow-up adopted in reported case series.
Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The investigators report on patients who were followed up after surgery at various time points over the course of 30 years.
Detailed description
We reviewed the charts of patients who underwent primary surgery for type II-IV Hiatal Hernia during the period from January 1980 - December 2010.
Pre-operatively, the patients routinely underwent symptom assessment, a barium swallow, upper GI endoscopy and esophageal manometry.
The principles of surgery for GERD and hiatal hernias involve full isolation of the diaphragmatic pillars and E-G junction, full isolation and resection of the sac and fat pad into the mediastinum (except for the fat close to the lesser curvature, to preserve the integrity of the vagus nerves), evaluation of the degree of esophageal shortening, and a Collis gastroplasty in cases of short esophagi.
Post-operatively, the patients participated in a free-of-charge outpatient follow-up program at 6 months, 12 months and every year for 5 years.
The length of the follow-up was calculated from the day of the surgery to the day that the patient underwent the last complete follow-up. The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (from 0 = absence of symptoms and esophagitis to 3 = severe symptoms and esophagitis). An evaluation scale for the surgical results, with scores ranging from "excellent" to "poor", was also used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Surgical TherapyGroup 1 = Patients with type II Hiatal Hernia submitted to surgical therapy |
| Group 2 | – | Procedure: Surgical TherapyGroup 2 = Patients with type III Hiatal Hernia submitted to surgical therapy |
| Group 3 | – | Procedure: Surgical TherapyGroup 3 = Patients with type IV Hiatal Hernia submitted to surgical therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consecutively operated upon for type II-IV hiatal hernia in the period January 1980-December 2010.
Key inclusion criteria (1 listed)
- patients aged > 18 years, undergoing surgery for the treatment of type II-IV hiatal hernia ± GERD.
Key exclusion criteria (4 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical TherapyOpen Anti-reflux fundoplication according to Nissen-Rossetti, floppy Nissen, Belsey MK IV,Collis Nissen, Collis-Belsey. Minimally-Invasive fundoplication according to floppy Nissen, left thoracoscopic Collis-laparoscopic Nissen. | Procedure or surgery | Group 1, Group 2, Group 3 |
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 25 May 2012.
- Derived from this study: PubMed 26377635Lugaresi M, Mattioli B, Daddi N, Di Simone MP, Perrone O, Mattioli S. Surgery for Type III-IV hiatal hernia: anatomical recurrence and global results after elective treatment of short oesophagus with open and minimally invasive surgery. Eur J Cardiothorac Surg. 2016 Apr;49(4):1137-43. doi: 10.1093/ejcts/ezv280. Epub 2015 Sep 16.
Related trials for Gastroesophageal Reflux Disease With Hiatal Hernia
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Active, not recruiting
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
GERD, Hiatal Hernia
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
Recruiting
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Hiatal Hernia, Paraesophageal, Hiatal Hernia Large
Not yet recruiting
Comparison of Laparoscopic Nissen Fundoplication and Hill-Snow Repair for Hiatus Hernia With Endoscopic Evaluation
Hiatal Hernia With Gastroesophageal Reflux Disease
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 principal investigator
Department of General Surgery and Organ Transplantations
1 site 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 With Hiatal Hernia and Paraesophageal Hernia, run by University of Bologna at 1 site 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 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 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
On the ClinicalTrials.gov record for NCT01606449, which also lists 1 linked publication.
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 25 May 2012.