Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
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|ClinicalTrials.gov Identifier: NCT03730233|
Recruitment Status : Active, not recruiting
First Posted : November 5, 2018
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hiatal Hernia||Procedure: Hiatal hernia repair by tension-free mesh closure Procedure: Hiatal hernia repair by simple suturing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||repair by tension-free mesh closure or simple suturing of the diaphragmatic|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||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.|
|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.|
|Actual Study Start Date :||January 11, 2006|
|Actual Primary Completion Date :||May 10, 2010|
|Estimated Study Completion Date :||December 2021|
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
- 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
- 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.
- Proton pump inhibitor (PPI) [ Time Frame: 12 month ]Use of PPI
- 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).
- 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
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730233
|Principal Investigator:||Anders Thorell, Professor||Karolinska Institutet|