Gastropexy in the Repair of Patients with Paraesophageal Hernias
NCT ID: NCT06107634
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2023-06-01
2030-08-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard paraesophageal hernia repair
Standard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication)
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 fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.
Standard paraesophageal hernia repair + gastropexy
Standard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy)
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 intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy").
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 fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.
Interventions
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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 intraabdominal pressure to the anterior abdominal wall with a 2-3 cm long running non-absorbable suture ("anterior gastropexy").
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 fundus is mobilized to allow a floppy fundoplication. A total fundoplication is created by three interrupted non-absorbable sutures. No bougies are used routinely for calibration of the fundoplication.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Sundsvall Hospital
OTHER
Karolinska Institutet
OTHER
Ersta Diakoni
OTHER
Responsible Party
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Marcus Reuterwall Hansson
PhD, senior consultant surgeon
Principal Investigators
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Anders Thorell, Professor
Role: STUDY_DIRECTOR
Ersta Diakoni
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Skåne University Hospital Lund
Lund, , Sweden
Nyköping Hospital
Nyköping, , Sweden
Ersta Hospital
Stockholm, , Sweden
Sundsvall County Hospital
Sundsvall, , Sweden
Uppsala Academic Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Alexandros Tsoposidis
Role: primary
Martin Jeremiasen, PhD
Role: primary
Apostolos Analatos, PhD
Role: primary
Michaela Breistrand
Role: primary
Yücel Cengiz, Associate professor
Role: primary
Johan Blixt Dackhammar, PhD Student
Role: backup
Gustav Linder, PhD
Role: primary
Other Identifiers
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Dnr 2023-01956-01
Identifier Type: -
Identifier Source: org_study_id