Gastropexy in the Repair of Patients with Paraesophageal Hernias

Last updated: December 13, 2024
Sponsor: Ersta Diakoni
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Gastropexy

Paraesophageal hernia repair

Clinical Study ID

NCT06107634
Dnr 2023-01956-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Previous major upper gastrointestinal (GI) surgery, including prior hiatal herniarepair.

  • Diagnosis of achalasia or any other significant esophageal motility disorder.

  • Inability to understand the purpose of the study and/or inability or unwillingnessto provide informed consent.

  • Severe comorbidities, defined by an American Society of Anesthesiologists (ASA)physical status score of greater than III.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Gastropexy
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
August 02, 2030

Study Description

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.

Connect with a study center

  • Sahlgrenska University Hospital

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

  • Skåne University Hospital Lund

    Lund, 221 85
    Sweden

    Site Not Available

  • Nyköping Hospital

    Nyköping, 611 85
    Sweden

    Active - Recruiting

  • Ersta Hospital

    Stockholm, 11691
    Sweden

    Active - Recruiting

  • Sundsvall County Hospital

    Sundsvall, 856 43
    Sweden

    Active - Recruiting

  • Uppsala Academic Hospital

    Uppsala, 751 85
    Sweden

    Active - Recruiting

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