DysphagiaNCT01501071
Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
A study testing Esophageal calibration tube in people with Dysphagia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic Nissen fundoplication became the standard surgical treatment of this disease. Although being almost transient postoperative dysphagia is still a common complaint following this procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysphagia
- What is being tested?
- Esophageal calibration tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Grade 3 or more esophagitis
- Hiatal hernia larger than 3 centimeters
- Acide suppression therapy history longer than 2 years
Who cannot join
- Story of endoscopic mucosal resection for Barret's mucosa
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of 2nd General Surgery
Antalya, 07100
About this study
Official title: Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia
Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic Nissen fundoplication became the standard surgical treatment of this disease. Although being almost transient postoperative dysphagia is still a common complaint following this procedure. The aim of this study is to investigate the effect of inserting a soft structured and blunt mounted 39 F orogastric tube to postoperative dysphagia.
- Conditions
- Dysphagia
- Being tested
- Esophageal calibration tube
- Keywords
- Laparoscopic Nissen fundoplication, Esophageal calibration, Postoperative dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal calibration tubeDevice
Also called A.M.I.Gastric tube code: AGB 355
An orogastric calibration tube is inserted during laparoscopic Nissen fundoplication in order to secure a certain esophageal lumen for reducing postoperative dysphagia
| Study group | Role | What they receive |
|---|---|---|
| esophageal calibration | Experimental | Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation Receives: Device: Esophageal calibration tube |
| Control | No intervention | Standard Laparoscopic Nissen fundoplication without esophageal calibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
dysphagia severity score
This score system is used to assess the severity of dysphagia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nurullah Bulbuller, Antalya Training and Research Hospital
- Investigators
- Nurullah Bulbuller, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501071
- Sponsor's protocol ID
- 001
- Status last verified
- Dec 2011
- First submitted
- 27 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
PubMed 984016Ronkainen J, Aro P, Storskrubb T, Lind T, Bolling-Sternevald E, Junghard O, Talley NJ, Agreus L. Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population--the Kalixanda study. Aliment Pharmacol Ther. 2006 Jun 15;23(12):1725-33. doi: 10.1111/j.1365-2036.2006.02952.x.
PubMed 16817916Rattner DW. Measuring improved quality of life after laparoscopic Nissen fundoplication. Surgery. 2000 Mar;127(3):258-63. doi: 10.1067/msy.2000.103881.
PubMed 10715979Terry M, Smith CD, Branum GD, Galloway K, Waring JP, Hunter JG. Outcomes of laparoscopic fundoplication for gastroesophageal reflux disease and paraesophageal hernia. Surg Endosc. 2001 Jul;15(7):691-9. doi: 10.1007/s004640080144. Epub 2001 May 7.
PubMed 11591970Pessaux P, Arnaud JP, Delattre JF, Meyer C, Baulieux J, Mosnier H. Laparoscopic antireflux surgery: five-year results and beyond in 1340 patients. Arch Surg. 2005 Oct;140(10):946-51. doi: 10.1001/archsurg.140.10.946.
PubMed 16230543Lafullarde T, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Laparoscopic Nissen fundoplication: five-year results and beyond. Arch Surg. 2001 Feb;136(2):180-4. doi: 10.1001/archsurg.136.2.180.
PubMed 11177138Gotley DC, Smithers BM, Rhodes M, Menzies B, Branicki FJ, Nathanson L. Laparoscopic Nissen fundoplication--200 consecutive cases. Gut. 1996 Apr;38(4):487-91. doi: 10.1136/gut.38.4.487.
PubMed 8707074Watson DI, Pike GK, Baigrie RJ, Mathew G, Devitt PG, Britten-Jones R, Jamieson GG. Prospective double-blind randomized trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels. Ann Surg. 1997 Nov;226(5):642-52. doi: 10.1097/00000658-199711000-00009.
PubMed 9389398Hunter JG, Swanstrom L, Waring JP. Dysphagia after laparoscopic antireflux surgery. The impact of operative technique. Ann Surg. 1996 Jul;224(1):51-7. doi: 10.1097/00000658-199607000-00008.
PubMed 8678618Patterson EJ, Herron DM, Hansen PD, Ramzi N, Standage BA, Swanstrom LL. Effect of an esophageal bougie on the incidence of dysphagia following nissen fundoplication: a prospective, blinded, randomized clinical trial. Arch Surg. 2000 Sep;135(9):1055-61; discussion 1061-2. doi: 10.1001/archsurg.135.9.1055.
PubMed 10982510Richardson WS, Hunter JG. Laparoscopic floppy Nissen fundoplication. Am J Surg. 1999 Feb;177(2):155-7. doi: 10.1016/s0002-9610(98)00324-9.
PubMed 10204561Schauer PR, Meyers WC, Eubanks S, Norem RF, Franklin M, Pappas TN. Mechanisms of gastric and esophageal perforations during laparoscopic Nissen fundoplication. Ann Surg. 1996 Jan;223(1):43-52. doi: 10.1097/00000658-199601000-00007.
PubMed 8554418Lowham AS, Filipi CJ, Hinder RA, Swanstrom LL, Stalter K, dePaula A, Hunter JG, Buglewicz TG, Haake K. Mechanisms and avoidance of esophageal perforation by anesthesia personnel during laparoscopic foregut surgery. Surg Endosc. 1996 Oct;10(10):979-82. doi: 10.1007/s004649900218.
PubMed 8864089Rantanen TK, Salo JA, Salminen JT, Kellokumpu IH. Functional outcome after laparoscopic or open Nissen fundoplication: a follow-up study. Arch Surg. 1999 Mar;134(3):240-4. doi: 10.1001/archsurg.134.3.240.
PubMed 10088561Somasekar K, Morris-Stiff G, Al-Madfai H, Barton K, Hassn A. Is a bougie required for the performance of the fundal wrap during laparoscopic Nissen fundoplication? Surg Endosc. 2010 Feb;24(2):390-4. doi: 10.1007/s00464-009-0592-2. Epub 2009 Jun 24.
PubMed 19551431
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia
- ClinicalTrials.gov ID
- NCT01501071
- Acronym / sponsor ID
- 001
- Conditions
- Dysphagia
- Keywords
- Laparoscopic Nissen fundoplication, Esophageal calibration, Postoperative dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Dec 2011 (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.
Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic Nissen fundoplication became the standard surgical treatment of this disease. Although being almost transient postoperative dysphagia is still a common complaint following this procedure. The aim of this study is to investigate the effect of inserting a soft structured and blunt mounted 39 F orogastric tube to postoperative dysphagia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esophageal calibration | Experimental | Device: Esophageal calibration tubeEsophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation |
| Control | No intervention | –Standard Laparoscopic Nissen fundoplication without esophageal calibration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Grade 3 or more esophagitis
- Hiatal hernia larger than 3 centimeters
- Acide suppression therapy history longer than 2 years
Key exclusion criteria (1 listed)
- Story of endoscopic mucosal resection for Barret's mucosa
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 calibration tubeAlso: A.M.I.Gastric tube code: AGB 355An orogastric calibration tube is inserted during laparoscopic Nissen fundoplication in order to secure a certain esophageal lumen for reducing postoperative dysphagia | Device | esophageal calibration |
Primary outcome
dysphagia severity score
Time frame: one year
This score system is used to assess the severity of dysphagia
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 29 Dec 2011.
- Background: PubMed 984016Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
- Background: PubMed 16817916Ronkainen J, Aro P, Storskrubb T, Lind T, Bolling-Sternevald E, Junghard O, Talley NJ, Agreus L. Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population--the Kalixanda study. Aliment Pharmacol Ther. 2006 Jun 15;23(12):1725-33. doi: 10.1111/j.1365-2036.2006.02952.x.
- Background: PubMed 10715979Rattner DW. Measuring improved quality of life after laparoscopic Nissen fundoplication. Surgery. 2000 Mar;127(3):258-63. doi: 10.1067/msy.2000.103881.
- Background: PubMed 11591970Terry M, Smith CD, Branum GD, Galloway K, Waring JP, Hunter JG. Outcomes of laparoscopic fundoplication for gastroesophageal reflux disease and paraesophageal hernia. Surg Endosc. 2001 Jul;15(7):691-9. doi: 10.1007/s004640080144. Epub 2001 May 7.
- Background: PubMed 16230543Pessaux P, Arnaud JP, Delattre JF, Meyer C, Baulieux J, Mosnier H. Laparoscopic antireflux surgery: five-year results and beyond in 1340 patients. Arch Surg. 2005 Oct;140(10):946-51. doi: 10.1001/archsurg.140.10.946.
- Background: PubMed 11177138Lafullarde T, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Laparoscopic Nissen fundoplication: five-year results and beyond. Arch Surg. 2001 Feb;136(2):180-4. doi: 10.1001/archsurg.136.2.180.
- Background: PubMed 8707074Gotley DC, Smithers BM, Rhodes M, Menzies B, Branicki FJ, Nathanson L. Laparoscopic Nissen fundoplication--200 consecutive cases. Gut. 1996 Apr;38(4):487-91. doi: 10.1136/gut.38.4.487.
- Background: PubMed 9389398Watson DI, Pike GK, Baigrie RJ, Mathew G, Devitt PG, Britten-Jones R, Jamieson GG. Prospective double-blind randomized trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels. Ann Surg. 1997 Nov;226(5):642-52. doi: 10.1097/00000658-199711000-00009.
- Background: PubMed 8678618Hunter JG, Swanstrom L, Waring JP. Dysphagia after laparoscopic antireflux surgery. The impact of operative technique. Ann Surg. 1996 Jul;224(1):51-7. doi: 10.1097/00000658-199607000-00008.
- Background: PubMed 10982510Patterson EJ, Herron DM, Hansen PD, Ramzi N, Standage BA, Swanstrom LL. Effect of an esophageal bougie on the incidence of dysphagia following nissen fundoplication: a prospective, blinded, randomized clinical trial. Arch Surg. 2000 Sep;135(9):1055-61; discussion 1061-2. doi: 10.1001/archsurg.135.9.1055.
- Background: PubMed 10204561Richardson WS, Hunter JG. Laparoscopic floppy Nissen fundoplication. Am J Surg. 1999 Feb;177(2):155-7. doi: 10.1016/s0002-9610(98)00324-9.
- Background: PubMed 8554418Schauer PR, Meyers WC, Eubanks S, Norem RF, Franklin M, Pappas TN. Mechanisms of gastric and esophageal perforations during laparoscopic Nissen fundoplication. Ann Surg. 1996 Jan;223(1):43-52. doi: 10.1097/00000658-199601000-00007.
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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.
Nurullah Bulbuller, MD study director
Antalya Training and Research Hospital
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 calibration tube in people with Dysphagia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 29 Dec 2011. 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 Turkey (Türkiye). 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?
dysphagia severity score (time frame: one 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 NCT01501071, which also lists 17 linked publications.
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 29 Dec 2011.