Gastroesophageal Reflux DiseaseNCT00287612
Necessity of Esophageal Dissection During Laparoscopic Fundoplication
A study testing Lap. Fundo. with Mobilization of the Esophageal Junction and Lap. Fundo. without Mobilization of the Esophageal Junction in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by Children's Mercy Hospital Kansas City at 2 sites in United States.
Trial summary
This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia
- What is being tested?
- Lap. Fundo. with Mobilization of the Esophageal Junction and Lap. Fundo. without Mobilization of the Esophageal Junction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Aug 2009
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Under 18 years of age
- Gastroesophageal Reflux Disease
Who cannot join
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)
- 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
2 sites in 1 country.
United States2 sites
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children
This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.
Read the detailed description
This will be a 2-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 either separating the phrenoesophageal membrane, or by leaving the phrenoesophageal membrane intact.
Sample size calculated on a power of 80% with an alpha level of 0.05 using the recurrence rates demonstrated by our retrospective data produce a number of 159 patients in each arm of the study. Given that we will need to follow these patients for 1 year after enrollment, there may be some attrition due to lost follow-up. Therefore 180 patients per arm would account for just over 10% attrition.
One group will undergo laparoscopic fundoplication with complete mobilization of the lower esophagus by circumferentially dividing the phrenoesophageal membrane. The other group will undergo laparoscopic fundoplication without dividing this membrane. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.
If 4 consecutive recurrences are found in one group, an interim analysis will be conducted. If a recurrence difference between groups of statistical significance is detected, the study will be concluded at this point. Without this occurrence, an interim analysis will be conducted at 180 patients enrolled.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Being tested
- Lap. Fundo. with Mobilization of the Esophageal Junction, Lap. Fundo. without Mobilization of the Esophageal Junction
- Keywords
- GERD, Hiatal Hernia, Recurrence
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lap. Fundo. with Mobilization of the Esophageal JunctionProcedure or surgery
Complete mobilization of the esophageal junction
Lap. Fundo. without Mobilization of the Esophageal JunctionProcedure or surgery
phrenoesophageal membrane left intact
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arms:Lap. Fundo. with Mobilization of the Esophageal Junction Receives: Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction |
| 2 | Experimental | Not described Receives: Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hiatal hernia
Measured: 1 year
Secondary outcomes (2)
control of symptoms
Measured: 1 year
retching
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2009
- Study completionAug 2009
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 Gastroesophageal 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287612
- Sponsor's protocol ID
- 05 12-150
- Status last verified
- Mar 2009
- First submitted
- 6 Feb 2006
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136.
PubMed 35171266
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children
- ClinicalTrials.gov ID
- NCT00287612
- Acronym / sponsor ID
- 05 12-150
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- GERD, Hiatal Hernia, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Feb 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Feb 2006 (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 study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.
Detailed description
This will be a 2-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 either separating the phrenoesophageal membrane, or by leaving the phrenoesophageal membrane intact.
Sample size calculated on a power of 80% with an alpha level of 0.05 using the recurrence rates demonstrated by our retrospective data produce a number of 159 patients in each arm of the study. Given that we will need to follow these patients for 1 year after enrollment, there may be some attrition due to lost follow-up. Therefore 180 patients per arm would account for just over 10% attrition.
One group will undergo laparoscopic fundoplication with complete mobilization of the lower esophagus by circumferentially dividing the phrenoesophageal membrane. The other group will undergo laparoscopic fundoplication without dividing this membrane. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.
If 4 consecutive recurrences are found in one group, an interim analysis will be conducted. If a recurrence difference between groups of statistical significance is detected, the study will be concluded at this point. Without this occurrence, an interim analysis will be conducted at 180 patients enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Lap. Fundo. with Mobilization of the Esophageal JunctionArms:Lap. Fundo. with Mobilization of the Esophageal Junction |
| 2 | Experimental | Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Under 18 years of age
- Gastroesophageal Reflux Disease
Key exclusion criteria (5 listed)
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)
- 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 |
|---|---|---|
| Lap. Fundo. with Mobilization of the Esophageal JunctionComplete mobilization of the esophageal junction | Procedure or surgery | 1 |
| Lap. Fundo. without Mobilization of the Esophageal Junctionphrenoesophageal membrane left intact | Procedure or surgery | 2 |
Primary outcome
Hiatal hernia
Time frame: 1 year
2 secondary outcomes
control of symptoms
Time frame: 1 year
retching
Time frame: 1 year
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 22 Sep 2009.
- Derived from this study: PubMed 35171266van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136.
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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 Kansas City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lap. Fundo. with Mobilization of the Esophageal Junction and Lap. Fundo. without Mobilization of the Esophageal Junction in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by Children's Mercy Hospital Kansas City at 2 sites 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 2 inclusion and 5 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 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 hernia (time frame: 1 year). 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 NCT00287612, 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 22 Sep 2009.