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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hiatal Hernia
• Intervention / Treatment: Procedure: Hiatal hernia repair by tension-free mesh closure; Procedure: Hiatal hernia repair by simple suturing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tension-free; Hiatal hernia repair by tension-free mesh closure	Procedure: Hiatal hernia repair by tension-free mesh closure
Active Comparator: Suturing; Hiatal hernia repair by simple suturing of the diaphragmatic	Procedure: Hiatal hernia repair by simple suturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Number of patients who had a bleeding or a leakage that requires a intervention, either blood transfusion or reoperation.	from operation day up to 12 month
Proton pump inhibitor (PPI)	Use of PPI	12 month
Quality of Life, physical and mental score: SF-36	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).	12 month
Postoperative oesophageal acid exposure	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	12 month
Gastrointestinal symptom rating scale (GSRS)	A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea).	12 month
Dysphagia	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.	12 month

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Thorell, Professor, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2006
• Primary Completion (Actual): May 10, 2010
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: 2006/37-31/4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No