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Completed

NCT Number: NCT03730233

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

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.

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Key information

Conditions

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

Age range

20 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The basic principles behind successful surgical repair of the anatomy and function of the gastro-oesophageal junction (GOJ) in gastro-oesophageal reflux disease (GORD) is not only to encircle the distal oesophagus and GOJ by the fundic wrap but also to complete a transhiatal reduction of a concomitant hiatal hernia (type I, HH), aiming for a 2 - 3 cm intra-abdominal length of the of oesophagus and to transact a tension-free hiatal closure. The physiological and morphological characteristics of the diaphragmatic hiatus, however, carry a challenge for the selection of the ideal technique for surgical repair. The diaphragmatic hiatus consists of a three-dimensional structure in constant motion, which creates a border between the counteracting pressures prevailing in the abdominal and chest cavities, respectively. Following hernia reduction, the structural quality of the diaphragmatic pillars is usually weak, offering poor support for the subsequent closure with risk for high recurrence rates. These and other considerations have encouraged the exploration of mesh reinforcement to enhance the durability of the hiatal closure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 .

Treatment and study plan

Hiatal hernia repair by tension-free mesh closure

Procedure

Hiatal hernia repair by simple suturing

Procedure

Primary outcomes

  1. Recurrent hiatal hernia

    Time frame: 12 month

    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

Secondary outcomes

  1. Complications

    Time frame: from operation day up to 12 month

    Number of patients who had a bleeding or a leakage that requires a intervention, either blood transfusion or reoperation.

  2. Proton pump inhibitor (PPI)

    Time frame: 12 month

    Use of PPI

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

    Time frame: 12 month

    The Swedish version of the validated global Short Form -36 (SF-36) questionnaire was used and data are presented as physical and mental summary component scores (PCS and MCS, respectively).

  4. Postoperative oesophageal acid exposure

    Time frame: 12 month

    Ambulatory 24-hour pH-monitoring was performed by use of a slim-line dual probe catheter system (single-use, 2 sensors, 15 cm spacing, ø 1.8 mm, Medtronic A/S, Skovlunde, Denmark). The oesophageal pH probe was positioned 5 cm above the upper border of the LOS as determined by manometry. Total time in percent of the total recording time with pH <4 was determined

  5. Gastrointestinal symptom rating scale (GSRS)

    Time frame: 12 month

    A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea).

  6. Dysphagia

    Time frame: 12 month

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. A Randomized, Double Blind Study With a 3-year Follow up.

Important dates

Study start
2006
Primary completion
2010
Study completion
2022
First posted
Nov 5, 2018
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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