Paraesophageal HerniaNCT05201508
Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
A study testing Polyglactin mesh and Sutures only in people with Paraesophageal Hernia and Hiatal Hernia, run by Oulu University Hospital at 1 site in Finland.
Trial summary
Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal
- What is being tested?
- Polyglactin mesh and Sutures only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFinland
- Study dates
- 21 Jan 2022to 1 Jan 2043
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Over 18 years old
- Type III-IV PEH with either radiologic or endoscopic confirmation
- Scheduled for laparoscopic PEH repair
- The informed consent is acquired
Who cannot join
- Need for esophagus lengthening procedure (Collis gastroplasty)
- Recurrent PEH
- Emergency surgery
- No written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, 90220
Olli Helminen, MD, PhD, +35883152011, olli.helminen@oulu.fi
About this study
Official title: Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. In order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. Non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. Traditionally used biological mesh materials are expensive and therefore problematic in routine use. Use of polyglactin (Vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. Previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. In this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. Primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. Secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.
- Being tested
- Polyglactin mesh, Sutures only
- Medical subject headings
- Hernia, Hiatal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglactin meshProcedure or surgery
Polyglactin mesh is used in keyhole manner to enforce hiatal closure
Sutures onlyProcedure or surgery
Traditional hiatal closure with non-absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| Sutures only | Active comparator | Traditional suture closure of hiatal defect Receives: Procedure: Sutures only |
| Polyglactin mesh | Experimental | In addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure. Receives: Procedure: Polyglactin mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic recurrence of PEH
Computed tomography based recurrence after sutures only versus polyglactin mesh
Measured: 6 months after surgery
Secondary outcomes (8)
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Measured: 6 months
Reoperation rate
Reoperation rate related to hiatal hernia recurrence
Measured: 20 years
Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)
The impact of PEH repair method to health-related quality of life score in esophago-gastric questionnaire (EORTC qlq-og25) at 6 months compared to preoperative level. Score is given between 25 and 100 points with higher score meaning worse quality of life.
Measured: 6 months
Hiatal defect size related to recurrence rate
The correlation with size of hiatal defect (cm^2) to recurrence rate (scatter plot with defect size in x-axis and recurrent hernias in y-axis)
Measured: 6 months
BMI and the risk of recurrence
The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)
Measured: 6 months
Proton pump inhibitor (PPI) use
Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh)
Measured: 20 years
Age and the risk of recurrence
The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)
Measured: 6 months
Albumin level and the risk of recurrence
The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)
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 posted21 Jan 2022
- Study start21 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraesophageal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective open label randomized trial
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District
- Responsible party
- Principal investigator, Olli Helminen, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201508
- Sponsor's protocol ID
- Sutures or mesh for PEH
- Status last verified
- Mar 2023
- First submitted
- 16 Dec 2021
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05201508
- Acronym / sponsor ID
- Sutures or mesh for PEH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2043 (estimated)
- First posted
- 21 Jan 2022 (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.
Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. In order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. Non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. Traditionally used biological mesh materials are expensive and therefore problematic in routine use. Use of polyglactin (Vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. Previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. In this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. Primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. Secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective open label randomized trial
| Arm | Type | Receives |
|---|---|---|
| Sutures only | Active comparator | Procedure: Sutures onlyTraditional suture closure of hiatal defect |
| Polyglactin mesh | Experimental | Procedure: Polyglactin meshIn addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Type III-IV PEH with either radiologic or endoscopic confirmation
- Scheduled for laparoscopic PEH repair
- The informed consent is acquired
Key exclusion criteria (4 listed)
- Need for esophagus lengthening procedure (Collis gastroplasty)
- Recurrent PEH
- Emergency surgery
- No written consent
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 |
|---|---|---|
| Polyglactin meshPolyglactin mesh is used in keyhole manner to enforce hiatal closure | Procedure or surgery | Polyglactin mesh |
| Sutures onlyTraditional hiatal closure with non-absorbable sutures. | Procedure or surgery | Sutures only |
Primary outcome
Radiographic recurrence of PEH
Time frame: 6 months after surgery
Computed tomography based recurrence after sutures only versus polyglactin mesh
8 secondary outcomes
Symptomatic versus asymptomatic recurrence rates
Time frame: 6 months
Reoperation rate
Time frame: 20 years
Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)
Time frame: 6 months
Hiatal defect size related to recurrence rate
Time frame: 6 months
BMI and the risk of recurrence
Time frame: 6 months
Proton pump inhibitor (PPI) use
Time frame: 20 years
Age and the risk of recurrence
Time frame: 6 months
Albumin level and the risk of recurrence
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Paraesophageal Hernia
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglactin mesh and Sutures only in people with Paraesophageal Hernia and Hiatal Hernia, run by Oulu University Hospital at 1 site in Finland.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Mar 2023. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olli Helminen, MD, PhD (+35883152011, olli.helminen@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic recurrence of PEH (time frame: 6 months after surgery). 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 27 Mar 2023.