Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730233
Recruitment Status : Active, not recruiting
First Posted : November 5, 2018
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

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


Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Anders Thorell, Professor Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Anders Thorell, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03730233    
Other Study ID Numbers: 2006/37-31/4
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic
Internal Hernia