Paraesophageal HerniaNCT04436159
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
A study testing Addition of 360 fundoplication after crural closure and Addition of 180 posterior fundoplication after crural closure in people with Paraesophageal Hernia and Gastro Esophageal Reflux, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraesophageal Hernia, Gastro Esophageal Reflux
- What is being tested?
- Addition of 360 fundoplication after crural closure and Addition of 180 posterior fundoplication after crural closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2009to Sep 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital
Who cannot join
- age below 18 years
- axial sliding hiatal hernia only (type I)
- missing informed consent
- previous hiatal hernia surgery
- American Society of Anesthesiologists (ASA) score IV or above
- achalasia
Show all 9Show fewer
- Zollinger-Ellison syndrome
- malignant tumor
- inability or unwillingness to complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial
Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication
Read the detailed description
Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.
One might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.
We therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.
Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.
Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36: physical and mental component scores.
Time points: 1, 3 and 6 months after surgery
- Conditions
- Paraesophageal Hernia, Gastro Esophageal Reflux
- Being tested
- Addition of 360 fundoplication after crural closure, Addition of 180 posterior fundoplication after crural closure
- Keywords
- Nissen fundoplication, Toupet fundoplication, crural repair, Quality of Life
- Medical subject headings
- Hernia, Hiatal, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of 360 fundoplication after crural closureProcedure or surgery
A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.
Addition of 180 posterior fundoplication after crural closureProcedure or surgery
The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures.
Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Nissen fundoplication | Active comparator | Addition of 360 fundoplication after crural closure Receives: Procedure: Addition of 360 fundoplication after crural closure |
| Toupet fundoplication | Active comparator | Addition of 180 posterior fundoplication after crural closure Receives: Procedure: Addition of 180 posterior fundoplication after crural closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ogilvie dysphagia score
The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .
Measured: 6 months
Secondary outcomes (6)
intra-and postoperative courses
Peri and postoperative complications.
Measured: 6 mohths
length of hospital stay
postoperative length of hospital stay
Measured: 6 months
Watson dysphagia score
Watson dysphagia score is a validated instrument for benign dysphagia where the patient is asked whether he/she always, sometimes or never has difficulty swallowing nine different groups of liquid and food items.
This gives a score ranging from zero to 45, where 45 represents the worst possible dysphagia.
Measured: 6 months
Acid reflux control
24-hour pH monitoring
Measured: 6 months
Quality of Life (SF-36)
The Swedish version of this validated global questionnaire is presented as physical and mental summary component scores (PCS and MCS, respectively). Each subscale scores reaches a value of at the most 100, where higher values reflect better health status.
Measured: 6 months
Radiology
Radiologically verified recurrent hiatal hernia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 May 2009
- Primary completionSep 2018
- Study completionSep 2018
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 Paraesophageal HerniaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Lars Lundell, professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436159
- Sponsor's protocol ID
- 2008/179-31
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Analatos A, Lindblad M, Ansorge C, Lundell L, Thorell A, Hakanson BS. Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac034. doi: 10.1093/bjsopen/zrac034.
PubMed 35511051
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04436159
- Acronym / sponsor ID
- 2008/179-31
- Conditions
- Paraesophageal Hernia, Gastro Esophageal Reflux
- Keywords
- Nissen fundoplication, Toupet fundoplication, crural repair, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Study start
- 1 May 2009 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Jun 2020 (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.
Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication
Detailed description
Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.
One might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.
We therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.
Six months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.
Dysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36: physical and mental component scores.
Time points: 1, 3 and 6 months after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nissen fundoplication | Active comparator | Procedure: Addition of 360 fundoplication after crural closureAddition of 360 fundoplication after crural closure |
| Toupet fundoplication | Active comparator | Procedure: Addition of 180 posterior fundoplication after crural closureAddition of 180 posterior fundoplication after crural closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital
Key exclusion criteria (9 listed)
- age below 18 years
- axial sliding hiatal hernia only (type I)
- missing informed consent
- previous hiatal hernia surgery
- American Society of Anesthesiologists (ASA) score IV or above
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 |
|---|---|---|
| Addition of 360 fundoplication after crural closureA total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall. | Procedure or surgery | Nissen fundoplication |
| Addition of 180 posterior fundoplication after crural closureThe wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures. Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively. | Procedure or surgery | Toupet fundoplication |
Primary outcome
Ogilvie dysphagia score
Time frame: 6 months
The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow .
6 secondary outcomes
intra-and postoperative courses
Time frame: 6 mohths
length of hospital stay
Time frame: 6 months
Watson dysphagia score
Time frame: 6 months
Acid reflux control
Time frame: 6 months
Quality of Life (SF-36)
Time frame: 6 months
Radiology
Time frame: 6 months
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 2 Sep 2021.
- Derived from this study: PubMed 35511051Analatos A, Lindblad M, Ansorge C, Lundell L, Thorell A, Hakanson BS. Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac034. doi: 10.1093/bjsopen/zrac034.
- 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.
Lars Lundell, professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of 360 fundoplication after crural closure and Addition of 180 posterior fundoplication after crural closure in people with Paraesophageal Hernia and Gastro Esophageal Reflux, run by Karolinska University Hospital at 1 site in Sweden.
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 9 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 2 Sep 2021. 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 Sweden. 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.
What does the primary outcome measure?
Ogilvie dysphagia score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436159, 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 2 Sep 2021.