Gastropexy in the Repair of Patients with Paraesophageal Hernias

Официальное название

Can Gastropexy Improve the Efficacy of the Crural Repair in Patients with Paraesophageal Hernias? a Double Blind, Randomized, Multicenter Clinical Trial

Обзор

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.

Подробное описание

Patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group.

Control Group: Patients undergo a crural repair combined with a short and floppy Nissen fundoplication.

Interventional Group: In addition to the crural repair and Nissen fundoplication, patients receive a gastropexy. This involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall.

Follow-Up Assessments:

Imaging: Computed tomography (CT) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes.

Patient-Reported Outcomes: The following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery:

SF-36: A global quality of life instrument. GSRS: The Gastrointestinal Symptoms Rating Scale. Reflux Frequency Questionnaire: A measure reflux disease-related symptoms. Dakkak's Dysphagia Score: An assessment of swallowing difficulties.

Вмешательства

• Процедура Gastropexy
  In the intervention group, a three-point gastropexy is added to the repair. First, the right fundus flap is adapted posteriorly to the crural portion of the diaphragm with a 2-3 cm long running non-absorbable suture ("posterior gastropexy"). Second, the left fundus flap is adapted to the diaphragm anterolateral to the hiatus with a 2-3 cm long running non-absorbable suture ("left anterolateral gastropexy"). Finally, the minor curvature of the anterior stomach wall is adapted during reduced intra
• Процедура Paraesophageal hernia repair
  Ultrasonic shears are used for dissection. The herniated viscera are completely reduced into the abdomen and the hernia sac in fully dissected and resected. The esophagus is mobilized intraabdominally until at least 3 cm rests below the hiatus without tension. The anterior and posterior vagal nerves are identified and preserved. A posterior crural closure with running non-absorbable sutures is performed. An additional anterior crural closure may be performed at the surgeon's discretion. The fund

Первичные конечные точки

• Recurrence of hernia at 1 year after surgery [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Recurrence of hernia at 3 years after surgery [Срок оценки: 3 year]
• Complications after surgery [Срок оценки: 30 days after surgery]
• Length of stay at the hospital after surgery [Срок оценки: 30 days after surgery]
• Changes in the patients perception of quality of life after surgery [Срок оценки: 3 months, 12 months, and 36 months]
• Changes in the patients perception of gastrointestinal symptoms after surgery [Срок оценки: 3 months, 12 months, and 36 months]
• Changes in the patients perception of dysphagia after surgery [Срок оценки: 3 months, 12 months, and 36 months]
• Changes in the patients perception of dysphagia and reflux frequency after surgery [Срок оценки: 3 months, 12 months, and 36 months]

Критерии участия

Критерии включения

\- Patients diagnosed with a primary paraesophageal hernia (hiatal hernia types II-IV) who are scheduled for elective or emergency surgical repair at participating centers

Критерии исключения

• Previous major upper gastrointestinal (GI) surgery, including prior hiatal hernia repair.
• Diagnosis of achalasia or any other significant esophageal motility disorder.
• Inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent.
• Severe comorbidities, defined by an American Society of Anesthesiologists (ASA) physical status score of greater than III.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швеция · 6 центров

• Sahlgrenska University Hospital — Gothenburg
• Skåne University Hospital Lund — Lund
• Nyköping Hospital — Nyköping
• Ersta Hospital — Stockholm
• Sundsvall County Hospital — Sundsvall
• Uppsala Academic Hospital — Uppsala

Публикации

• Dackhammar JB, Tsoposidis A, Wallenius V, Kostic S, Cengiz Y, Linder G, Jeremiasen M, Analatos A, Lundell L, Hakanson B, Thorell A, Hansson MR. Can gastropexy reduce the recurrence rate after paraesophageal hernia repair? A study protocol for a double blind, randomized, multicenter clinical trial. Trials. 2026 Mar 16;27(1):281. doi: 10.1186/s13063-026-09578-7. PMID 41840686

Идентификаторы

NCT: NCT06107634 · Dnr 2023-01956-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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