Gastropexy as a Treatment Option for Paraesophageal Hernia

NCT ID: NCT06096402

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-12-31

Brief Summary

The present proposal aims to asses which is the optimal treatment strategy in a clinical study in patients with paraoesophageal hernia (PEH), a condition often found in elderly, fragile patients The investigator want to study the optimal approach to a paraoesophageal hernia (PEH) repair. The incidence of PEH increases with age and the older patient typically has additional co-morbidities, reduced physiological fitness, and frailty which makes surgery challenging regarding increased morbidity and mortality. Thus, the decision to offer surgery can be challenging in this cohort of patients. The need of an anti-reflux procedure as part of the repair is one of the main subjects for discussion worldwide. To date no consensus exists and many surgical centres do a routine anti-reflux procedure as part of their standard operation for PEH. But is this procedure redundant? Can the patients be managed with a less complicated procedure; an anterior gastropexy with comparable outcome?

Detailed Description

A hiatal hernia is a widening of the diaphragmatic hiatus causing herniation of the stomach into the thoracic cavity. It develops because of an insufficiency of the hiatus. The paraesophageal hernias (PEH) are classified as grade II-IV hiatal hernia with at least 50 % of the stomach misplaced in the thoracic cavity.

A paraesophageal hernia (PEH) is a potentially dangerous condition. One see in varied degree, the stomach and other organs being misplaced above diaphragm, in the thoracic cavity. Symptoms such as dysphagia, vomitus, weight loss, pain, short breath and emergent situations where abdominal organs are strangulated with risk of tissue death in thorax defines whether a patient should be offered operation and how fast it should be performed.

The operative management of PEH has become a laparoscopic procedure within the last 20-30 years with a concomitant significant decrease in morbidity and length of hospital stay. It is managed by different subspecialized surgeons, all of them having different perspectives and approaches to this condition. Surgery in this area is potentially high-risk operations with risk of perforation of oesophagus, injury to lungs, aorta, pericardia, spleen and stomach. Without operation symptomatic patients with PEH are at risk of developing an acute surgical condition with organ perforation with high per-and postoperative mortality.

Contemporary surgical technique is divided into three crucial steps; 1) removal of the hernia sac, 2) hiatoplasty with or without mesh and 3) an anti-reflux procedure and/or gastropexy. Each step is managed differently among surgeons/centres worldwide with varying evidence. Many surgeons add an anti-reflux procedure to the surgical management of PEH, to protect against postoperative acid reflux. The argument is that an anti-reflux procedure lowers postoperative reflux and recurrence of the paraesophageal hernia, but this is without clear evidence. As an addition or an alternative in step three of the PEH procedure, some centres do an anterior gastropexy to anchor the stomach in the abdominal cavity. It is a simple technique compared with an anti-reflux procedure with possibly equal satisfactory long-term outcomes but less postoperative complications. However, evidence is sparse and larger studies on this technique are highly warranted.

The aim is to study the need of a fundoplication as part of the procedure for PEH regarding symptom control and quality of life. For this reason, The investigator want to set up a prospective two-armed multicenter study in collaboration with St. Olav's Hospital, Trondheim and Gastroenheden, Hvidovre, Denmark. The reason for this collaboration is 1) to enlarge the group of investigation, as PEH is a rare condition, 2) to compare current practice (fundoplication/no fundoplication) among the included institutions. .

Conditions

Paraesophageal Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

anterior gastropexy, no fundoplication

patients with indication of operative management of a paraesophageal hernia

no intervention, but surgical practice as usual is continued. Its a pragmatic study

Intervention Type: PROCEDURE

no intervention

anterior gastropexy and fundoplication

patients with indication of operative management of a paraesophageal hernia

no intervention, but surgical practice as usual is continued. Its a pragmatic study

Intervention Type: PROCEDURE

no intervention

Interventions

no intervention, but surgical practice as usual is continued. Its a pragmatic study

no intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Both emergent and elective repair of the paraoesophageal hernia

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Kim Erlend Mortensen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim Erlend Mortensen, MD, PhD

Role: STUDY_DIRECTOR

University of North Norway

Locations

Hvidovre Hospital

Copenhagen, , Denmark

University Hospital of North Norway

Harstad, , Norway

St Olavs Hospital

Trondheim, , Norway

Countries

Denmark; Norway

Central Contacts

Lene Osterballe, MD

Role: CONTACT

lene.osterballe@unn.no

+4797572401

Facility Contacts

Mahdi Alamili, MD,PhD

Role: primary

Lene Osterballe, MD

Role: primary

Per Even Storli, MD

Role: primary

Other Identifiers

625668 (REK)

Identifier Type: -

Identifier Source: org_study_id