Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

NCT03730233 | Completed

• 1 other identifier: 2006/37-31/4
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of PPI, postoperative oesophageal acid exposure and Quality of Life.

Conditions

Hiatal Hernia

Outcome Measures

Primary Outcomes (1)

• Recurrent hiatal hernia

  The incidence of radiologically verified recurrent hiatal hernia. Examined in the erect position after a 4-hour fast when 250 ml of low-density barium sulphate suspension (45% weight per volume) was ingested. The patients were instructed to drink the served volume within 30 seconds. Thereafter three sagittal spot films (35 x 35 cm) of the distal esophagus and GEJ were exposed 1, 2 and 5 minutes after the start of the barium ingestion (16). In

  12 month

Secondary Outcomes (6)

• Complications

  from operation day up to 12 month

• Proton pump inhibitor (PPI)

  12 month

• Quality of Life, physical and mental score: SF-36

  12 month

• Postoperative oesophageal acid exposure

  12 month

• Gastrointestinal symptom rating scale (GSRS)

  12 month

Study Arms (2)

Tension-free

ACTIVE COMPARATOR

Hiatal hernia repair by tension-free mesh closure

Procedure: Hiatal hernia repair by tension-free mesh closure

Suturing

ACTIVE COMPARATOR

Hiatal hernia repair by simple suturing of the diaphragmatic

Procedure: Hiatal hernia repair by simple suturing

Interventions

Hiatal hernia repair by tension-free mesh closure PROCEDURE

Tension-free

Hiatal hernia repair by simple suturing PROCEDURE

Suturing

Eligibility Criteria

• Age: 20 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for elective laparoscopic total fundoplication
• symptomatic gastro oesophageal reflux disease (GORD) and HH of \> 2 cm in axial length
• total esophageal acid exposure for more than 4 % of monitored time

You may not qualify if:

• if insufficient capacity prevailed to understand the study protocol,
• if the patient had undergone previous major upper gastrointestinal surgery (except for GORD or HH)
• ASA classification of \>2 .

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (1)

• Analatos A, Hakanson BS, Lundell L, Lindblad M, Thorell A. Tension-free mesh versus suture-alone cruroplasty in antireflux surgery: a randomized, double-blind clinical trial. Br J Surg. 2020 Dec;107(13):1731-1740. doi: 10.1002/bjs.11917. Epub 2020 Sep 16.

  PMID: 32936951 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The randomization process was initiated after general anesthesia had been induced and the group affiliation was determined by opening of a sealed envelope specifying the group assignment. The subsequent operation report, with information on the specific type of repair performed, was not included in the digital patient-chart. Instead, a hard copy was printed and kept in a sealed envelope, which was filed in a locked archive to maintain the patient, staff and clinical assessors blinded to the study group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: repair by tension-free mesh closure or simple suturing of the diaphragmatic

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 5, 2018
• Study Start: January 11, 2006
• Primary Completion: May 10, 2010
• Study Completion: May 31, 2022
• Last Updated: October 3, 2023

Record last verified: 2023-10