Gastropexy in the Repair of Patients with Paraesophageal Hernias

NCT06107634 | Recruiting DMC

• 1 other identifier: Dnr 2023-01956-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Paraesophageal Hernia

Outcome Measures

Primary Outcomes (1)

• Recurrence of hernia at 1 year after surgery

  Computer tomography of abdomen and thorax

  1 year

Secondary Outcomes (7)

• Recurrence of hernia at 3 years after surgery

  3 year

• Complications after surgery

  30 days after surgery

• Length of stay at the hospital after surgery

  30 days after surgery

• Changes in the patients perception of quality of life after surgery

  3 months, 12 months, and 36 months

• Changes in the patients perception of gastrointestinal symptoms after surgery

  3 months, 12 months, and 36 months

Study Arms (2)

Standard paraesophageal hernia repair

ACTIVE COMPARATOR

Standard paraesophageal hernia repair (crural suturing and a total (Nissen) fundoplication)

Procedure: Paraesophageal hernia repair

Standard paraesophageal hernia repair + gastropexy

EXPERIMENTAL

Standard paraesophageal hernia repair with the addition of a three point gastropexy (posterior, left anterolateral and anterior gastropexy)

Procedure: Gastropexy; Procedure: Paraesophageal hernia repair

Interventions

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").

Standard paraesophageal hernia repair + 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.

Standard paraesophageal hernia repair; Standard paraesophageal hernia repair + gastropexy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ersta Diakoni: lead
• Göteborg University: collaborator
• Sundsvall Hospital: collaborator
• Karolinska Institutet: collaborator

Study Sites (6)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Skåne University Hospital Lund

Lund, 221 85, Sweden

NOT YET RECRUITING

Nyköping Hospital

Nyköping, 611 85, Sweden

RECRUITING

Ersta Hospital

Stockholm, 11691, Sweden

RECRUITING

Sundsvall County Hospital

Sundsvall, 856 43, Sweden

RECRUITING

Uppsala Academic Hospital

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal

Interventions

Gastropexy

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Anders Thorell, Professor

  Ersta Diakoni

  STUDY DIRECTOR

Central Study Contacts

Marcus Reuterwall Hansson, PhD

CONTACT

+466147500; marcus.reuterwall.hansson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, senior consultant surgeon

Model Details: Conventional paraesophageal hernia repair with the addition of gastropexy

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 30, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): August 2, 2030
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)