Gastropexy in the Repair of Patients with Paraesophageal Hernias (PEH3)

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

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

Study Overview

• Status: Recruiting
• Conditions: Paraesophageal Hernia
• Intervention / Treatment: Procedure: Paraesophageal hernia repair; Procedure: Gastropexy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcus Reuterwall Hansson, PhD; Phone Number: +466147500; Email: marcus.reuterwall.hansson@ki.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Alexandros Tsoposidis; Phone Number: +4631-3421000; Email: alexandros.tsoposidis@gu.se
  • Lund, Sweden, 221 85
    • Not yet recruiting
    • Skane University Hospital Lund
    • Contact: Martin Jeremiasen, PhD; Phone Number: +4646-171000; Email: martin.jeremiasen@med.lu.se
  • Nyköping, Sweden, 611 85
    • Recruiting
    • Nyköping Hospital
    • Contact: Apostolos Analatos, PhD; Phone Number: +46155-245000; Email: apanalat@gmail.com
  • Stockholm, Sweden, 11691
    • Recruiting
    • Ersta Hospital
    • Contact: Michaela Breistrand; Phone Number: 087146500; Email: michaela.breistrand@erstadiakoni.se
  • Sundsvall, Sweden, 856 43
    • Recruiting
    • Sundsvall County Hospital
    • Contact: Yücel Cengiz, Associate professor; Phone Number: +4660181000; Email: yucel.cengiz@rvn.se
    • Contact: Johan Blixt Dackhammar, PhD Student; Phone Number: +4660181000; Email: johan.blixt.dackhammar@rvn.se
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Uppsala Academic Hospital
    • Contact: Gustav Linder, PhD; Phone Number: +4618-6110000; Email: gustav.linder@uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard paraesophageal hernia repair; Standard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication)	Procedure: 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.
Experimental: Standard paraesophageal hernia repair + gastropexy; Standard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy)	Procedure: 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.; Procedure: 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").

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of hernia at 1 year after surgery	Computer tomography of abdomen and thorax	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of hernia at 3 years after surgery	Computer tomography of abdomen and thorax	3 year
Complications after surgery	Complication classified according to Clavien-Dindo	30 days after surgery
Length of stay at the hospital after surgery	Information from patients journal	30 days after surgery
Changes in the patients perception of quality of life after surgery	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.	3 months, 12 months, and 36 months
Changes in the patients perception of gastrointestinal symptoms after surgery	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.	3 months, 12 months, and 36 months
Changes in the patients perception of dysphagia after surgery	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.	3 months, 12 months, and 36 months
Changes in the patients perception of dysphagia and reflux frequency after surgery	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.	3 months, 12 months, and 36 months

Collaborators and Investigators

• Sponsor: Ersta Diakoni
• Collaborators: Karolinska Institutet; Göteborg University; Sundsvall Hospital
• Investigators: Study Director: Anders Thorell, Professor, Ersta Diakoni

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): August 2, 2030

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Hernia; Hernia, Hiatal
• Other Study ID Numbers: Dnr 2023-01956-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No