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: Gastropexy

Detailed Description

Patient undergoing surgery for primary paraesophageal herniation, are randomized to either the control group or interventional group. The control group have a crural repair alone to which is added a short and floppy Nissen fundoplication. The interventional arm contains the addition of a gastropexy which incorporates fixation of the left part of the wrap to the diaphragm as well as the posterior part to the right crus. Finally the minor curvature of the stomach is sutured left to the midline of the abdominal wall.

The patients are examined by computed tomography before surgery and at 1 and 3 years after surgery.

SF-36 (global quality of Life instrument), GSRS (Gastrointestinal Symptoms Rating Scale), Reflux frequency issues and Watson's dysphagia score are completed before and at 3 and 6 month as well as 1 and 3 years after surgery.

• 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
  • Stockholm, Sweden, 11691
    • Recruiting
    • Ersta Hospital
    • Contact: Michaela Breistrand; Phone Number: 087146500; Email: michaela.breistrand@erstadiakoni.se

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery

Exclusion Criteria:

• American Society of Anesthesiologists physical status-system (ASA) >III
• inability to understand the nature of the purpose of the study and/or to give informed consent.
• Achalasia or another severe esophageal motor disorder
• Previous major upper GI surgery(including previous hiatal hernia repair)

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
No Intervention: Standard paraesophageal hernia repair; Standard paraesophageal hernia repair(Crura suture with total (Nissen) fundoplication))
Active Comparator: Standard paraesophageal hernia repair +gastropexy; Standard paraesophageal hernia repair with the addition of gastropexy(anterior, posterior and left gastropexy)	Procedure: Gastropexy; In the intervention group, the following three additional attachment points between the stomach and surrounding anatomical structures will be completed with non-absorbable suture material: The left lateral part of the fundus flap is adapted to the diaphragm at its flat tendinous part of the diaphragm lateral to the hiatus, with a 2-3 cm long continuous non-absorbable suture ("left postero-lateral gastropexy").; The anterior stomach wall is attached to the abdominal wall with a 2-3 cm long continuous non-absorbable suture ("anterior gastropexy").; The posterior fundus is adapted to the right crus with a 2-3 cm long non-absorbable suture ("right-posterior 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	Symptomatic recurrence	at approximately 10 weeks after surgery
Changes in the patients perception of gastrointestinal symptoms after surgery	GSRS = The Gastrointestinal Symptom Rating Scale. Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should 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) Watson dysphagia score and clinical evaluation. The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.	3 months, 12 months, 24 months and 36 months
Changes in the patients perception of dysphagia after surgery - Dakkak	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, 24 months and 36 months
Changes in the patients perception of dysphagia after surgery	Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.	3 months, 12 months, 24 months and 36 months
Length of stay at the hospital after surgery	Information from patients journal	at approximately 10 weeks after surgery
Manometric characteristics of the oesophagus	To assess oesophageal function at 1 yr postoperative High resolution manometry(HRM) will be performed. Postoperative primary peristalsis will be classified according to the Chicago classification.	1 year
Esophageal distensibility characteristics of the oesophagus	To assess oesophageal function at 1 yr postoperative functional lumen imaging probe (endoFLIP) will be performed. Postoperative secondary peristalsis and distensibility in the distal oesophagus will be characterized with the endo-FLIP system. Measurement unit is mm2/mmHg.	1 year
Changes in the patients perception of quality of life after surgery	SF-36 (Quality of Life issues) The SF-36 is comprised of 36 items that assess eight health concepts: 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. Scoring is from 0-100. A mean score of 50 has been articulated as normative value.	3 months, 12 months, 24 months and 36 months
Number of study participants administered post-operative analgetics in addition to standard baseline postoperative analgetic regime.	Information from patients eletcronic drug journal	at approximately 10 weeks after surgery

Collaborators and Investigators

• Sponsor: Ersta Diakoni
• Collaborators: 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): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; 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