Trials · 2026
Can gastropexy reduce the recurrence rate after paraesophageal hernia repair? A study protocol for a double blind, randomized, multicenter clinical trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Dackhammar J Blixt, Tsoposidis A, Wallenius V, Kostic S, Cengiz Y, Linder G, Jeremiasen M, Analatos A, Lundell L, Håkanson B, Thorell A, Hansson M Reuterwall
Аннотация
BACKGROUND: Despite several attempts to improve the durability of the reconstruction of paraesophageal hernias (PEH), recurrence rates remain high. Gastropexy has often been added to the reconstruction with the intention to reduce recurrence rates by anchoring the stomach in the abdominal cavity. The efficacy of adding gastropexy to standard PEH repair has, however, not yet been investigated in a randomized controlled trial setting.
METHODS: All patients scheduled for PEH repair are assessed for eligibility for enrolment. Preoperative work-up includes upper GI endoscopy, computed tomography, and symptom assessments. Participants will be randomized (1:1) to either the control or intervention group. In the control group, patients will have a standardized repair, including posterior crural repair and a total fundoplication. In the intervention group, a three-point gastropexy using running non-absorbable sutures will be added to the same reconstruction as in the control group: a posterior fixation of the wrap to the diaphragm, a lateral fixation of the left wrap to the diaphragm, and an anterior fixation of the minor curvature to the inner surface of the anterior abdominal wall. The primary outcome is computed tomography-verified radiological recurrence at 1 year. Secondary outcomes include radiological recurrence at 3 years, patient-reported quality of life, and disease-specific symptoms at 3 months, 1 year, and 3 years, as well as postoperative complications. The study design is double-blinded, with both participants and outcome assessors being blinded to the allocation of patients to treatment arms.
DISCUSSION: Although gastropexy is frequently used in PEH repair with the intent to reduce recurrence rates, the scientific evidence behind its effects is limited. The present trial is the first RCT to evaluate the efficacy of gastropexy combined with a standardized PEH repair.
TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, NCT06107634 . Registered 9 September 2023.
METHODS: All patients scheduled for PEH repair are assessed for eligibility for enrolment. Preoperative work-up includes upper GI endoscopy, computed tomography, and symptom assessments. Participants will be randomized (1:1) to either the control or intervention group. In the control group, patients will have a standardized repair, including posterior crural repair and a total fundoplication. In the intervention group, a three-point gastropexy using running non-absorbable sutures will be added to the same reconstruction as in the control group: a posterior fixation of the wrap to the diaphragm, a lateral fixation of the left wrap to the diaphragm, and an anterior fixation of the minor curvature to the inner surface of the anterior abdominal wall. The primary outcome is computed tomography-verified radiological recurrence at 1 year. Secondary outcomes include radiological recurrence at 3 years, patient-reported quality of life, and disease-specific symptoms at 3 months, 1 year, and 3 years, as well as postoperative complications. The study design is double-blinded, with both participants and outcome assessors being blinded to the allocation of patients to treatment arms.
DISCUSSION: Although gastropexy is frequently used in PEH repair with the intent to reduce recurrence rates, the scientific evidence behind its effects is limited. The present trial is the first RCT to evaluate the efficacy of gastropexy combined with a standardized PEH repair.
TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, NCT06107634 . Registered 9 September 2023.