RefluxNCT01509352
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
A study testing esophageal stitches during fundoplication and no esophageal stitches placed during fundoplication in people with Reflux, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This is a prospective trial of the utility of esophageal stitches during fundoplication. The hypothesis is that recurrence rate may be different with or without the esophageal stitches. Read more about this study
- Who is it for?
- Ages 1 day to 7 years
- Conditions the study is for
- Reflux
- What is being tested?
- esophageal stitches during fundoplication and no esophageal stitches placed during fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2015
- 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 1 day to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.
Who cannot join
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.
This is a prospective trial of the utility of esophageal stitches during fundoplication.
The hypothesis is that recurrence rate may be different with or without the esophageal stitches.
Read the detailed description
This will be a single center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane intact in all patients.
One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.
- Conditions
- Reflux
- Being tested
- esophageal stitches during fundoplication, no esophageal stitches placed during fundoplication
- Keywords
- fundoplication, gastric reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophageal stitches during fundoplicationProcedure or surgery
Also called crural stitches.
placement of esophageal stitches with fundoplication
no esophageal stitches placed during fundoplicationProcedure or surgery
Also called crural stitches
no esophageal stitches are placed during the fundoplication procedure
| Study group | Role | What they receive |
|---|---|---|
| with esophageal stitches | Active comparator | fundoplication with crural stitches Receives: Procedure: esophageal stitches during fundoplication |
| without esophageal stitches | Experimental | fundoplication without crural stitches. Receives: Procedure: no esophageal stitches placed during fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
hiatal herniation
Measured: 4 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startFeb 2010
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RefluxStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509352
- Sponsor's protocol ID
- 10 01-003
- Status last verified
- Jan 2017
- First submitted
- 14 Dec 2011
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.
- ClinicalTrials.gov ID
- NCT01509352
- Acronym / sponsor ID
- 10 01-003
- Conditions
- Reflux
- Keywords
- fundoplication, gastric reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Jan 2012 (estimated)
- 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.
This is a prospective trial of the utility of esophageal stitches during fundoplication.
The hypothesis is that recurrence rate may be different with or without the esophageal stitches.
Detailed description
This will be a single center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane intact in all patients.
One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with esophageal stitches | Active comparator | Procedure: esophageal stitches during fundoplicationfundoplication with crural stitches |
| without esophageal stitches | Experimental | Procedure: no esophageal stitches placed during fundoplicationfundoplication without crural stitches. |
Who may qualify
- Ages
- 1 day to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.
Key exclusion criteria (4 listed)
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)
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 |
|---|---|---|
| esophageal stitches during fundoplicationAlso: crural stitches.placement of esophageal stitches with fundoplication | Procedure or surgery | with esophageal stitches |
| no esophageal stitches placed during fundoplicationAlso: crural stitchesno esophageal stitches are placed during the fundoplication procedure | Procedure or surgery | without esophageal stitches |
Primary outcome
hiatal herniation
Time frame: 4 year follow-up
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 26 Jan 2017.
- 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.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophageal stitches during fundoplication and no esophageal stitches placed during fundoplication in people with Reflux, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 1 inclusion and 4 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
hiatal herniation (time frame: 4 year follow-up). 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 26 Jan 2017.