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

Hiatal Hernia Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730233
• Other study ID #: 2006/37-31/4
• Status: Completed
• Phase: N/A
• Start date: January 11, 2006
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 31, 2022
• Est. primary completion date: May 10, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 72 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Procedure:
• Hiatal hernia repair by tension-free mesh closure

• Hiatal hernia repair by simple suturing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proton pump inhibitor (PPI)	Use of PPI	12 month
Secondary	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
Secondary	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
Secondary	Gastrointestinal symptom rating scale (GSRS)	A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea).	12 month
Secondary	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