Gastro Oesophageal Reflux DiseaseNCT04335734
Influence of Wrap Fixation Technique on the Results of Fundoplication
A study testing Nissen Fundoplication with wrap fixation and Nissen Fundoplication without wrap fixation in people with Gastro Oesophageal Reflux Disease, run by Grubnik Volodymyr.
Trial summary
Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastro Oesophageal Reflux Disease
- What is being tested?
- Nissen Fundoplication with wrap fixation and Nissen Fundoplication without wrap fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2012to 28 May 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20 - 80 years;
- Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
- HH type I, II
Who cannot join
- Age < 20 years and > 80 years;
- Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
- HH type III, IV;
- BMI < 16 and > 45 kg/m²;
- Pregnancy (in females);
- Oesophageal motility disorders;
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- Oesophageal peptic strictures;
- Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
- History of oesophageal/gastric/duodenal surgery including vagotomy;
- Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
About this study
Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.
- Conditions
- Gastro Oesophageal Reflux Disease
- Being tested
- Nissen Fundoplication with wrap fixation, Nissen Fundoplication without wrap fixation
- Keywords
- Gastro Oesophageal Reflux Disease, Nissen Fundoplication
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nissen Fundoplication with wrap fixationProcedure or surgery
Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side.
Nissen Fundoplication without wrap fixationProcedure or surgery
Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Nissen fundoplication with fixation of the wrap | Active comparator | In this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. . Receives: Procedure: Nissen Fundoplication with wrap fixation |
| Nissen fundoplication without fixation of the wrap | Active comparator | Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation. Receives: Procedure: Nissen Fundoplication without wrap fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of hiatal hernia
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Measured: 60 months
Slipped wrap
Slipped wrap will be assessed by barium contrast swallow study
Measured: 60 months
Secondary outcomes (1)
Quality of life and satisfaction
Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Nov 2012
- Primary completion1 Oct 2014
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Oesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grubnik Volodymyr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grubnik Volodymyr, Odessa National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335734
- Sponsor's protocol ID
- ONMedU 1
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Wrap Fixation Technique on the Results of Fundoplication
- ClinicalTrials.gov ID
- NCT04335734
- Acronym / sponsor ID
- ONMedU 1
- Conditions
- Gastro Oesophageal Reflux Disease
- Keywords
- Gastro Oesophageal Reflux Disease, Nissen Fundoplication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Grubnik VolodymyrUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 6 Apr 2020 (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.
Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nissen fundoplication with fixation of the wrap | Active comparator | Procedure: Nissen Fundoplication with wrap fixationIn this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. . |
| Nissen fundoplication without fixation of the wrap | Active comparator | Procedure: Nissen Fundoplication without wrap fixationArm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20 - 80 years;
- Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
- HH type I, II
Key exclusion criteria (10 listed)
- Age < 20 years and > 80 years;
- Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
- HH type III, IV;
- BMI < 16 and > 45 kg/m²;
- Pregnancy (in females);
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 |
|---|---|---|
| Nissen Fundoplication with wrap fixationFirstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side. | Procedure or surgery | Nissen fundoplication with fixation of the wrap |
| Nissen Fundoplication without wrap fixationFirstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. | Procedure or surgery | Nissen fundoplication without fixation of the wrap |
Primary outcome
Recurrence rate of hiatal hernia
Time frame: 60 months
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Slipped wrap
Time frame: 60 months
Slipped wrap will be assessed by barium contrast swallow study
1 secondary outcome
Quality of life and satisfaction
Time frame: 60 months
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 6 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nissen Fundoplication with wrap fixation and Nissen Fundoplication without wrap fixation in people with Gastro Oesophageal Reflux Disease, run by Grubnik Volodymyr.
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 10 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 6 Apr 2020. 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?
Recurrence rate of hiatal hernia (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2020.