The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia

NCT04179578 | Active Not Recruiting

• 1 other identifier: 2019-02801
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.

Conditions

Paraesophageal Hernia

Outcome Measures

Primary Outcomes (1)

• Rat of reherniating

  computer tomography of abdomen and thorax

  1 year

Secondary Outcomes (6)

• complications after operation

  1 year

• change in quality of life

  1 year

• Patients analgesic consumption after operation

  1 year

• Length of Stay (LOS)

  1 year

• sick leave period

  1 year

Study Arms (2)

Crura

ACTIVE COMPARATOR

Closure of the diaphragmatic hiatus by a running suture alone

Procedure: Crura plastic

Crura and lateral release

ACTIVE COMPARATOR

Closure of the diaphragmatic hiatus by a running suture and an incision of 4 cm of the left diaphragm (lateral release)

Procedure: Crura plastic

Interventions

Crura plastic PROCEDURE

Closure of hiatus with a running suture

Crura; Crura and lateral release

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• inability to understand the nature of the purpose of the study and/or to give informed consent.
• American Society of Anesthesiologists physical status-system (ASA) \>III
• Achalasia or another severe esophageal motor disorder

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Ersta Hospital

Stockholm, Region Stockholm, 116 91, Sweden

Location

Related Publications (1)

• Tsoposidis A, Thorell A, Axelsson H, Reuterwall Hansson M, Lundell L, Wallenius V, Kostic S, Hakanson B. The value of "diaphragmatic relaxing incision" for the durability of the crural repair in patients with paraesophageal hernia: a double blind randomized clinical trial. Front Surg. 2023 Nov 10;10:1265370. doi: 10.3389/fsurg.2023.1265370. eCollection 2023.

  PMID: 38026477 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

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

Study Officials

• Anders Thorell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

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: Professor

Model Details: Crura plastic or crura plastic with the addition of "lateral release"

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 27, 2019
• Study Start: July 16, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)