Gastroesophageal RefluxNCT00382850
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
A study testing Nissen fundoplication in people with Gastroesophageal Reflux, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Nissen fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to 30 Nov 2010
- 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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical or radiographic diagnosis of gastroesophageal reflux
- age less than 2 years (24 months) at the time of surgery
Who cannot join
- prior fundoplication procedure
- concomitant need for an intraabdominal procedure (except gastrostomy tube placement)
- esophageal dysmotility
- hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age
The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age.
Read the detailed description
Nissen fundoplication is a commonly performed procedure in infants and children with gastroesophageal reflux and a variety of other medical conditions including respiratory compromise, severe neurologic impairment, failure to thrive and swallowing dysfunction. Randomized controlled trials in adults have shown that laparoscopic fundoplication is a safe procedure that results in lower morbidity, shorter hospital length of stay and similar 5-year recurrence rates when compared to an open procedure. The aim of this study is to compare laparoscopic and open Nissen fundoplication in children less than 2 years of age.
Children younger than 2 years of age presenting for Nissen fundoplication will be randomized to either a laparoscopic or an open procedure. Patients who have already undergone anti-reflux surgery or whose hospitalization is anticipated to be prolonged by an unrelated illness will be excluded. All procedures will be performed at a single institution by two surgeons who will perform both the open and laparoscopic procedures.
A total of 68 patients will be needed (34 in each group) to detect a 20% difference in length of stay at a significance level of p < 0.05 and power of 80%. Patients will be followed for up to 2 years postoperatively. Variables to be compared between the two groups will include age, gender, presence of neurologic impairment, presence and specification of any congenital abnormalities, total operative time, total dose of narcotic analgesia required, postoperative day on which the patient tolerated full feedings, postoperative and total lengths of stay as well as the occurrence of postoperative complications (including wound infection and the need for immediate reoperation). The primary outcomes analyzed will be length of stay and amount of narcotic analgesia required. Longer-term outcomes including persistent GERD, wrap failure and need for reoperation within 24 months of the initial procedure also will be determined.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Nissen fundoplication
- Keywords
- Nissen fundoplication, gastroesophageal 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.
Nissen fundoplicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| open nissen fundoplication | Active comparator | open repair through surgical midline incision Receives: Procedure: Nissen fundoplication |
| laparoscopic nissen fundoplication | Active comparator | use of laparoscope to do repair Receives: Procedure: Nissen fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative length of stay
days in hospital
Measured: 0 to 14days
postoperative narcotic pain medication requirements
days requiring narcotics for pain relief
Measured: 0 to 14 days
length of time to tolerating full feeds prior to discharge
days after surgery before feeding begins
Measured: 0 to 7 days
Secondary outcomes (4)
intraoperative complication rates
complications of procedure
Measured: duration of procedure
wrap failure and need for subsequent reoperation
operative failure
Measured: up to 2 yrs
need for continued medical therapy for GER
symptomatic reflux requiring medication
Measured: up to 2 yrs
death
death
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startNov 2005
- Primary completion30 Nov 2010
- Study completion30 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul M Colombani, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382850
- Sponsor's protocol ID
- 05-08-01-01
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2006
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age
- ClinicalTrials.gov ID
- NCT00382850
- Acronym / sponsor ID
- 05-08-01-01
- Conditions
- Gastroesophageal Reflux
- Keywords
- Nissen fundoplication, gastroesophageal reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- 30 Nov 2010 (actual)
- Study completion
- 30 Nov 2010 (actual)
- First posted
- 2 Oct 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.
The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age.
Detailed description
Nissen fundoplication is a commonly performed procedure in infants and children with gastroesophageal reflux and a variety of other medical conditions including respiratory compromise, severe neurologic impairment, failure to thrive and swallowing dysfunction. Randomized controlled trials in adults have shown that laparoscopic fundoplication is a safe procedure that results in lower morbidity, shorter hospital length of stay and similar 5-year recurrence rates when compared to an open procedure. The aim of this study is to compare laparoscopic and open Nissen fundoplication in children less than 2 years of age.
Children younger than 2 years of age presenting for Nissen fundoplication will be randomized to either a laparoscopic or an open procedure. Patients who have already undergone anti-reflux surgery or whose hospitalization is anticipated to be prolonged by an unrelated illness will be excluded. All procedures will be performed at a single institution by two surgeons who will perform both the open and laparoscopic procedures.
A total of 68 patients will be needed (34 in each group) to detect a 20% difference in length of stay at a significance level of p < 0.05 and power of 80%. Patients will be followed for up to 2 years postoperatively. Variables to be compared between the two groups will include age, gender, presence of neurologic impairment, presence and specification of any congenital abnormalities, total operative time, total dose of narcotic analgesia required, postoperative day on which the patient tolerated full feedings, postoperative and total lengths of stay as well as the occurrence of postoperative complications (including wound infection and the need for immediate reoperation). The primary outcomes analyzed will be length of stay and amount of narcotic analgesia required. Longer-term outcomes including persistent GERD, wrap failure and need for reoperation within 24 months of the initial procedure also will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open nissen fundoplication | Active comparator | Procedure: Nissen fundoplicationopen repair through surgical midline incision |
| laparoscopic nissen fundoplication | Active comparator | Procedure: Nissen fundoplicationuse of laparoscope to do repair |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinical or radiographic diagnosis of gastroesophageal reflux
- age less than 2 years (24 months) at the time of surgery
Key exclusion criteria (4 listed)
- prior fundoplication procedure
- concomitant need for an intraabdominal procedure (except gastrostomy tube placement)
- esophageal dysmotility
- hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)
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 | Procedure or surgery | laparoscopic nissen fundoplication, open nissen fundoplication |
Primary outcome
postoperative length of stay
Time frame: 0 to 14days
days in hospital
postoperative narcotic pain medication requirements
Time frame: 0 to 14 days
days requiring narcotics for pain relief
length of time to tolerating full feeds prior to discharge
Time frame: 0 to 7 days
days after surgery before feeding begins
4 secondary outcomes
intraoperative complication rates
Time frame: duration of procedure
wrap failure and need for subsequent reoperation
Time frame: up to 2 yrs
need for continued medical therapy for GER
Time frame: up to 2 yrs
death
Time frame: up to 2 years
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 1 Aug 2018.
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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.
Paul M Colombani, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nissen fundoplication in people with Gastroesophageal Reflux, run by Johns Hopkins University 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 2 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 1 Aug 2018. 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?
postoperative length of stay (time frame: 0 to 14days). The study lists 3 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 1 Aug 2018.