GERDNCT05851794
Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes
A study testing endomanometric guided LNF and laparoscopic Nissen fundoplication alone in people with GERD, run by Zagazig University.
Trial summary
Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- GERD
- What is being tested?
- endomanometric guided LNF and laparoscopic Nissen fundoplication alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 1 Apr 2023
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 18≥ years with large sliding hiatus hernia (> 5 cm) with severe GERD patients (DeMeester score >100)with typical symptoms and successful medical management (due to quality of life considerations, life-long need medication intake or cost) or patients with unresponsive or inadequate symptom control despite eight weeks of adequate medical therapy with or without extra-esophageal Atypical symptoms that are related to GERD(cough, Globus, or hoarseness) confirmed diagnosis by hypotensive lower esophageal sphincter confirmed by HRM and a positive pH/impedance test (based on DeMeester scores)
- fitness and consenting for surgery
- patients that completed three year follow up period,
- with esophagitis
Who cannot join
- <18years,
- pregnancy,
- Patients unfit for surgery [ comorbid condition like severe cardiac illness, chronic respiratory diseases, chronic renal failure, and bleeding disorder],
- Non cooperative or lost patients for regular follow up,
- Patients who had undergone previous antireflux surgery or who required a concurrent abdominal procedure at the same time as fundoplication (eg, cholecystectomy), -
- psychiatric disorders.
- esophageal dysmotility,
About this study
Official title: Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes in Large Sliding Hiatus Hernia With Severe Gastroesophageal Reflux Disease (DeMeester Score >100). A Retrospective Comparative Study.
Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively
Read the detailed description
Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.
Study design: This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively.
This study contributes to the mounting evidence for the effectiveness of endomanometric use during LNF. Intraoperative HRM and Endoscope were feasible in all patients and demonstrated that the clinical outcomes for endomanometric NF were favorable from an effectiveness and safety standpoint.
- Conditions
- GERD
- Being tested
- endomanometric guided LNF, laparoscopic Nissen fundoplication alone
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endomanometric guided LNFProcedure or surgery
use of endomanometry during LNF
laparoscopic Nissen fundoplication aloneProcedure or surgery
laparoscopic Nissen fundoplication alone
| Study group | Role | What they receive |
|---|---|---|
| endomanometric laparoscopic Nissen fundoplication | Active comparator | use endomanometry and endoscope during laparoscopic Nissen fundoplication Receives: Procedure: endomanometric guided LNF |
| laparoscopic Nissen fundoplication alone | Active comparator | laparoscopic Nissen fundoplication only Receives: Procedure: laparoscopic Nissen fundoplication alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
DeMeester score (0-3)
0 is best while 3 is worst
Measured: 3 years
dysphagia score(0-3)
0 is best while 3 is worst
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Apr 2012
- Primary completion1 Apr 2020
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851794
- Sponsor's protocol ID
- GERD
- Status last verified
- Jul 2023
- First submitted
- 1 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes in Large Sliding Hiatus Hernia With Severe Gastroesophageal Reflux Disease (DeMeester Score >100). A Retrospective Comparative Study.
- ClinicalTrials.gov ID
- NCT05851794
- Acronym / sponsor ID
- GERD
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 10 May 2023 (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.
Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively
Detailed description
Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (>5cm) with severe GERD (DeMeester score >100), is needed.
Study design: This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively.
This study contributes to the mounting evidence for the effectiveness of endomanometric use during LNF. Intraoperative HRM and Endoscope were feasible in all patients and demonstrated that the clinical outcomes for endomanometric NF were favorable from an effectiveness and safety standpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endomanometric laparoscopic Nissen fundoplication | Active comparator | Procedure: endomanometric guided LNFuse endomanometry and endoscope during laparoscopic Nissen fundoplication |
| laparoscopic Nissen fundoplication alone | Active comparator | Procedure: laparoscopic Nissen fundoplication alonelaparoscopic Nissen fundoplication only |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients 18≥ years with large sliding hiatus hernia (> 5 cm) with severe GERD patients (DeMeester score >100)with typical symptoms and successful medical management (due to quality of life considerations, life-long need medication intake or cost) or patients with unresponsive or inadequate symptom control despite eight weeks of adequate medical therapy with or without extra-esophageal Atypical symptoms that are related to GERD(cough, Globus, or hoarseness) confirmed diagnosis by hypotensive lower esophageal sphincter confirmed by HRM and a positive pH/impedance test (based on DeMeester scores)
- fitness and consenting for surgery
- patients that completed three year follow up period,
- with esophagitis
Key exclusion criteria (7 listed)
- <18years,
- pregnancy,
- Patients unfit for surgery [ comorbid condition like severe cardiac illness, chronic respiratory diseases, chronic renal failure, and bleeding disorder],
- Non cooperative or lost patients for regular follow up,
- Patients who had undergone previous antireflux surgery or who required a concurrent abdominal procedure at the same time as fundoplication (eg, cholecystectomy), -
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 |
|---|---|---|
| endomanometric guided LNFuse of endomanometry during LNF | Procedure or surgery | endomanometric laparoscopic Nissen fundoplication |
| laparoscopic Nissen fundoplication alonelaparoscopic Nissen fundoplication alone | Procedure or surgery | laparoscopic Nissen fundoplication alone |
Primary outcome
DeMeester score (0-3)
Time frame: 3 years
0 is best while 3 is worst
dysphagia score(0-3)
Time frame: 3 years
0 is best while 3 is worst
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 Jul 2023.
- Individual participant dataSharing planned: No
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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 endomanometric guided LNF and laparoscopic Nissen fundoplication alone in people with GERD, run by Zagazig University.
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 4 inclusion and 7 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 Jul 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?
DeMeester score (0-3) (time frame: 3 years). 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 Jul 2023.