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NCT Number: NCT06107634

Gastropexy in the Repair of Patients with Paraesophageal Hernias

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

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Key information

Conditions

Paraesophageal Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • 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.

Treatment and study plan

Gastropexy

Procedure

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

Procedure

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.

Primary outcomes

  1. Recurrence of hernia at 1 year after surgery

    Time frame: 1 year

    Computer tomography of abdomen and thorax

Secondary outcomes

  1. Recurrence of hernia at 3 years after surgery

    Time frame: 3 year

    Computer tomography of abdomen and thorax

  2. Complications after surgery

    Time frame: 30 days after surgery

    Complication classified according to Clavien-Dindo

  3. Length of stay at the hospital after surgery

    Time frame: 30 days after surgery

    Information from patients journal

  4. Changes in the patients perception of quality of life after surgery

    Time frame: 3 months, 12 months, and 36 months

    SF-36 (Short Form 36) is a health related quality of life questionnaire. SF-36 is comprised of 36 items that assess eight dimensions of health: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Higher scores mean a better outcome. These can be grouped into mental and physical component summary scores. Scoring is from 0-100. A mean score of 50 has been articulated as normative value.

  5. Changes in the patients perception of gastrointestinal symptoms after surgery

    Time frame: 3 months, 12 months, and 36 months

    GSRS (The Gastrointestinal Symptom Rating Scale) is a questionnaire, which contains 15 items, and uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. The questions are grouped in five dimensions. A mean value for the items in each dimension will be calculated:

    Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation

    Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus

    Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation

    Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting

    Reflux syndrome: 2. Heartburn 3. Acid regurgitation.

  6. Changes in the patients perception of dysphagia after surgery

    Time frame: 3 months, 12 months, and 36 months

    The Dakkak dysphagia score is a questionnaire for assessing benign dysphagia, including nine questions regarding the frequency (always, sometimes, or never) of swallowing difficulties with different food consistencies (liquid, semisolid, and solid foods). The final score ranges from 0 to 45, where 45 represents the most severe dysphagia.

  7. Changes in the patients perception of dysphagia and reflux frequency after surgery

    Time frame: 3 months, 12 months, and 36 months

    Symptoms of heartburn, reflux, chest pain, dysphagia for liquids and solids, dyspnea, coughing and odynophagia were recorded using a four-graded scale to assess the frequency of symptoms with an arbitrary (empirical) cut off for clinical significance. The same instrument has been used in a previous RCT, from the same institution, comparing different types of anti-reflux procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus Reuterwall Hansson, PhD

CONTACT

[email protected]

+466147500

Sponsors and collaborators

Lead sponsor

Ersta Diakoni

Other

Collaborators

  • Göteborg University
  • Karolinska Institutet
  • Sundsvall Hospital

Registry information

Official study title

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

Acronym: PEH3

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Oct 30, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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