An interventional study of Polyglactin mesh and Sutures only in Paraesophageal Hernia, Hiatal Hernia and Hiatal Hernia, Paraesophageal, sponsored by Oulu University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Prevention
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 110 is close to the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional suture closure of hiatal defect
Procedure: Sutures only
In addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure.
Procedure: Polyglactin mesh
Polyglactin mesh is used in keyhole manner to enforce hiatal closure
Traditional hiatal closure with non-absorbable sutures.
Radiographic recurrence of PEH
Computed tomography based recurrence after sutures only versus polyglactin mesh
Time frame: 6 months after surgery
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Time frame: 6 months
Reoperation rate
Reoperation rate related to hiatal hernia recurrence
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Plan to share: No
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