Hiatal HerniaNCT03730233
Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
A study testing Hiatal hernia repair by tension-free mesh closure and Hiatal hernia repair by simple suturing in people with Hiatal Hernia, run by Karolinska Institutet.
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… Read more about this study
- Who is it for?
- Ages 20 to 72 years
- Conditions the study is for
- Hiatal Hernia
- What is being tested?
- Hiatal hernia repair by tension-free mesh closure and Hiatal hernia repair by simple suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2006to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 .
About this study
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.
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.
Read the 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.
- Conditions
- Hiatal Hernia
- Being tested
- Hiatal hernia repair by tension-free mesh closure, Hiatal hernia repair by simple suturing
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hiatal hernia repair by tension-free mesh closureProcedure or surgery
Hiatal hernia repair by simple suturingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Tension-free | Active comparator | Hiatal hernia repair by tension-free mesh closure Receives: Procedure: Hiatal hernia repair by tension-free mesh closure |
| Suturing | Active comparator | Hiatal hernia repair by simple suturing of the diaphragmatic Receives: Procedure: Hiatal hernia repair by simple suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Secondary outcomes (6)
Complications
Number of patients who had a bleeding or a leakage that requires a intervention, either blood transfusion or reoperation.
Measured: from operation day up to 12 month
Proton pump inhibitor (PPI)
Use of PPI
Measured: 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).
Measured: 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
Measured: 12 month
Gastrointestinal symptom rating scale (GSRS)
A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea).
Measured: 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start11 Jan 2006
- Primary completion10 May 2010
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- repair by tension-free mesh closure or simple suturing of the diaphragmatic
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730233
- Sponsor's protocol ID
- 2006/37-31/4
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2018
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32936951
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03730233
- Acronym / sponsor ID
- 2006/37-31/4
- Conditions
- Hiatal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Jan 2006 (actual)
- Primary completion
- 10 May 2010 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- repair by tension-free mesh closure or simple suturing of the diaphragmatic
| Arm | Type | Receives |
|---|---|---|
| Tension-free | Active comparator | Procedure: Hiatal hernia repair by tension-free mesh closureHiatal hernia repair by tension-free mesh closure |
| Suturing | Active comparator | Procedure: Hiatal hernia repair by simple suturingHiatal hernia repair by simple suturing of the diaphragmatic |
Who may qualify
- Ages
- 20 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hiatal hernia repair by tension-free mesh closure | Procedure or surgery | Tension-free |
| Hiatal hernia repair by simple suturing | Procedure or surgery | Suturing |
Primary outcome
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
6 secondary outcomes
Complications
Time frame: from operation day up to 12 month
Proton pump inhibitor (PPI)
Time frame: 12 month
Quality of Life, physical and mental score: SF-36
Time frame: 12 month
Postoperative oesophageal acid exposure
Time frame: 12 month
Gastrointestinal symptom rating scale (GSRS)
Time frame: 12 month
Dysphagia
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 32936951Analatos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Thorell, Professor principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Hiatal hernia repair by tension-free mesh closure and Hiatal hernia repair by simple suturing in people with Hiatal Hernia, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent hiatal hernia (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.