Study Results
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Basic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2011-12-31
2013-04-30
Brief Summary
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In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no study has been performed investigating the use of CO2 in SBE.
The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.
Detailed Description
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In 2007, we could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no research has been performed investigating the use of CO2 in SBE.
BAE is a long-lasting procedure. Large volumes of air are insufflated during the procedure, leading to significant distension of the small bowel during and after the examination.
One of the main technical difficulties in BAE is the formation of small bowel loops and sharp angels during deep intubation of the endoscope. These loops and angels are the major restriction to deep intubation of the endoscope. Loops and sharp angels are more pronounced in air-distended bowel segments.
The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.
Hypothesis
1. The use of CO2 in SBE leads to a reduction in abdominal pain for the patient when compared with the use of air.
2. The use of CO2 in SBE leads to deeper intubation when compared to air insufflation.
The study is designed as a two-center randomized controlled trial. Randomization to the two groups (CO2 vs. air insufflation) is performed of individual participant basis.
Randomization to the two groups (CO2 vs air insufflation) is performed on basis of the individual participant. Equally large groups are randomized, using block randomization (blocks of six patients) for each of the participating centers. Randomization (using SPSS statistical software package) is performed by an independent researcher, who is not part of the SBE team.
Individuals eligible for inclusion are patients referred for SBE at the trial centers who do not fulfill one of the following exclusion criteria:
* Age under 16 years
* Inability to understand information for participation
* Refusal of participation
All eligible individuals are informed about the nature of the study. All individuals provide written informed consent before entering the trial. Patients who do not wish to participate in the present trial are treated according to standard procedures (using air insufflation).
All procedures are performed by experienced endoscopists. Both patients and endoscopists are blinded with regard to type of gas used for any particular patient.
Sedation is performed according to current standards at the centers. Single-balloon procedure SBE is performed using the SBE endoscope system (SIF-Q180, Olympus Optical, Tokyo, Japan), as described in the literature 2-4.
Gas insufflation CO2 is insufflated using EZEM equipment (or other, to be specified). Air is insufflated using the ordinary air inlet system of the endoscope rack. The air inlet button is hidden from the view of the endoscopist to prevent unblinding (technical details to be specified in cooperation with company).
For evaluation of pain and discomfort, a questionnaire is used to classify patient pain during and after the procedure. Visual analogue scales (100-mm) are used to quantify abdominal pain during the examination and at 1, 3, 6, and 24 hours after the procedure, as validated in recent studies7,8. The questionnaire is given to every participant after the procedure, to be filled in the next day.
All procedure parameters of interest (e.g. duration, depth of insertion, use of sedatives) are registered by the endoscopist immediately after the examination using the existing GI lab databases.
Ethics The regional ethics committees of the participating centers will be asked for approval of the study protocol.
Power analysis: a 25% improvement of intubation depth is considered to be clinically important to detect. On the basis of our DBE-CO2-study9, power calculation was conducted determining the size of the study (n=66).
Ownership data are owned by the respective centers. Publication of the study results is planned in a peer-reviewed journal. Philipp Lenz and Dirk Domagk will co-ordinate study design, data generation and analysis and a first manuscript draft.
Budget: All procedures in the present study are performed in ordinary patients, with ordinary staff and endoscopists. Therefore, no extra costs occur for personal.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Air
Air as insufflation gas during single-balloon enteroscopy.
Single-Balloon-Enteroscopy with Air as insufflation gas.
Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.
CO2
CO2 as insufflation gas during single-balloon enteroscopy.
Single-Balloon-Enteroscopy with CO2 as insufflation gas.
Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.
Interventions
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Single-Balloon-Enteroscopy with Air as insufflation gas.
Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.
Single-Balloon-Enteroscopy with CO2 as insufflation gas.
Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to understand information for participation
* Refusal of participation
16 Years
ALL
No
Sponsors
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Albert Schweitzer Hospital
OTHER
Nuovo Ospedale Civile S.Agostino Estense
OTHER
Azienda Ospedaliera San Giovanni Battista
OTHER
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Dirk Domagk, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine B
Locations
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University Hopstial of Muenster, Department of Medicine B
Münster, , Germany
HELIOS Albert-Schweitzer-Hospital
Northeim, , Germany
Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S.Agostino-Estense
Baggiovara Di Modena, , Italy
San Giovanni Battista University Teaching Hospital, Department of Medicine, Division of Gastroenterology 2
Torino, , Italy
Countries
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References
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Yamamoto H, Sekine Y, Sato Y, Higashizawa T, Miyata T, Iino S, Ido K, Sugano K. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc. 2001 Feb;53(2):216-20. doi: 10.1067/mge.2001.112181.
Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. doi: 10.1055/s-2007-966616. Epub 2007 Oct 24. No abstract available.
Tsujikawa T, Saitoh Y, Andoh A, Imaeda H, Hata K, Minematsu H, Senoh K, Hayafuji K, Ogawa A, Nakahara T, Sasaki M, Fujiyama Y. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy. 2008 Jan;40(1):11-5. doi: 10.1055/s-2007-966976. Epub 2007 Dec 4.
Domagk D, Mensink P, Aktas H, Lenz P, Meister T, Luegering A, Ullerich H, Aabakken L, Heinecke A, Domschke W, Kuipers E, Bretthauer M. Single- vs. double-balloon enteroscopy in small-bowel diagnostics: a randomized multicenter trial. Endoscopy. 2011 Jun;43(6):472-6. doi: 10.1055/s-0030-1256247. Epub 2011 Mar 7.
Hussein AM, Bartram CI, Williams CB. Carbon dioxide insufflation for more comfortable colonoscopy. Gastrointest Endosc. 1984 Apr;30(2):68-70. doi: 10.1016/s0016-5107(84)72319-4.
Bretthauer M, Thiis-Evensen E, Huppertz-Hauss G, Gisselsson L, Grotmol T, Skovlund E, Hoff G. NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy. Gut. 2002 May;50(5):604-7. doi: 10.1136/gut.50.5.604.
Stevenson GW, Wilson JA, Wilkinson J, Norman G, Goodacre RL. Pain following colonoscopy: elimination with carbon dioxide. Gastrointest Endosc. 1992 Sep-Oct;38(5):564-7. doi: 10.1016/s0016-5107(92)70517-3.
Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
Domagk D, Bretthauer M, Lenz P, Aabakken L, Ullerich H, Maaser C, Domschke W, Kucharzik T. Carbon dioxide insufflation improves intubation depth in double-balloon enteroscopy: a randomized, controlled, double-blind trial. Endoscopy. 2007 Dec;39(12):1064-7. doi: 10.1055/s-2007-966990.
Hirai F, Beppu T, Nishimura T, Takatsu N, Ashizuka S, Seki T, Hisabe T, Nagahama T, Yao K, Matsui T, Beppu T, Nakashima R, Inada N, Tajiri E, Mitsuru H, Shigematsu H. Carbon dioxide insufflation compared with air insufflation in double-balloon enteroscopy: a prospective, randomized, double-blind trial. Gastrointest Endosc. 2011 Apr;73(4):743-9. doi: 10.1016/j.gie.2010.10.003. Epub 2011 Jan 14.
Lenz P, Meister T, Manno M, Pennazio M, Conigliaro R, Lebkucher S, Ullerich H, Schmedt A, Floer M, Beyna T, Lenze F, Domagk D. CO2 insufflation during single-balloon enteroscopy: a multicenter randomized controlled trial. Endoscopy. 2014 Jan;46(1):53-8. doi: 10.1055/s-0033-1359041. Epub 2013 Dec 18.
Other Identifiers
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CO2 Insufflation During SBE
Identifier Type: OTHER
Identifier Source: secondary_id
18052011
Identifier Type: -
Identifier Source: org_study_id