Gastroesophageal RefluxNCT01260935
Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
A study testing Laparoscopic Hill Repair and Laparoscopic Nissen Repair in people with Gastroesophageal Reflux and Esophageal Reflux, run by Swedish Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux, Esophageal Reflux, Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic Hill Repair and Laparoscopic Nissen Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
- > 18 years of age and < 75 years of age
Who cannot join
- hiatal hernias measuring > 7 cm
- esophageal body amplitude < 30 or in two or more segments
- < 40% propagated peristaltic waves
- GE junction > 5 cm above the esophageal hiatus
- dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
- body mass index > 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Cancer Institute
Seattle, Washington, 98104
About this study
Official title: A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.
Read the detailed description
The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.
- Being tested
- Laparoscopic Hill Repair, Laparoscopic Nissen Repair
- Keywords
- GERD, laparoscopic surgery, 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.
Laparoscopic Hill RepairProcedure or surgery
With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.
Laparoscopic Nissen RepairProcedure or surgery
With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Laparoscopic Hill Receives: Procedure: Laparoscopic Hill Repair |
| Arm B | Active comparator | Laparoscopic Nissen Receives: Procedure: Laparoscopic Nissen Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).
Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay.
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 posted15 Dec 2010 (estimated)
- Study startNov 2002
- Primary completionNov 2010
- Study completionNov 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.
- 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
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph Aye, MD, Principal investigator, Swedish Medical Center Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260935
- Sponsor's protocol ID
- IR 3722
- Status last verified
- Jan 2012
- First submitted
- 30 Nov 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
- ClinicalTrials.gov ID
- NCT01260935
- Acronym / sponsor ID
- IR 3722
- Keywords
- GERD, laparoscopic surgery, gastroesophageal, reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Dec 2010 (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 compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.
Detailed description
The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: Laparoscopic Hill RepairLaparoscopic Hill |
| Arm B | Active comparator | Procedure: Laparoscopic Nissen RepairLaparoscopic Nissen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
- > 18 years of age and < 75 years of age
Key exclusion criteria (6 listed)
- hiatal hernias measuring > 7 cm
- esophageal body amplitude < 30 or in two or more segments
- < 40% propagated peristaltic waves
- GE junction > 5 cm above the esophageal hiatus
- dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
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 |
|---|---|---|
| Laparoscopic Hill RepairWith the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine. | Procedure or surgery | Arm A |
| Laparoscopic Nissen RepairWith the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations. | Procedure or surgery | Arm B |
Primary outcome
Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).
Time frame: 1 year
Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay.
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 18 Jan 2012.
Related trials for Gastroesophageal Reflux
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Ralph Aye, MD principal investigator
Swedish Medical Center Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Hill Repair and Laparoscopic Nissen Repair in people with Gastroesophageal Reflux and Esophageal Reflux, run by Swedish Medical Center 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 6 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 18 Jan 2012. 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?
Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). (time frame: 1 year). 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 18 Jan 2012.