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| Name | Class |
|---|---|
| European Society of Pediatric Gastroenterology, Hepatology and Nutrition | OTHER |
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Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.
Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.
The primary objective is to determine the safety of the CO2 insufflation during PEG. The secondary objective of this study is to investigate the inhibitory effect of CO2 insufflation on bowel distension.
This is an investigator initiated multicentre, randomized, double blind study to evaluate the safety and adverse events profile of CO2 insufflation during PEG procedure. The study included a screening, pre-intervention (pre-PEG) and a post-intervention time (after-PEG), with total of 4 measurements of waist circumference, two measurements of i-stat.
Children aged 0-19 years, who were admitted for PEG procedure and who meet all inclusion and none of the exclusion criteria listed below. A total of 120 children after PEG insertion will be included and divided in two groups: one step group and standard pull group of children; two established groups will be randomized 1:1.
Inclusion criteria
Due to study protocol capillary blood will be withdrawn twice. To conclude there are actually no additional risks for included children due to the study protocol. Moreover, we will be able to diagnose early the important pneumoperitoneum, if it will occur and start to treat it with effective pain killers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single steep arm- CO2 insufflation | Experimental | PEG will be performed by single step technique and CO2 will be insufflated during the endoscopy |
|
| Single steep arm- air insufflation | Active Comparator | PEG will be performed by single step technique and air will be insufflated during the endoscopy |
|
| Pull technique arm- CO2 insufflation | Experimental | PEG will be performed by pull technique and CO2 will be insufflated during the endoscopy |
|
| Pull technique arm- air insufflation | Active Comparator | PEG will be performed by pull technique and air will be insufflated during the endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 | Other | to insufflate CO2 into the stomach instead of air during the PEG |
|
| Measure | Description | Time Frame |
|---|---|---|
| To asses the change in pCO2 before and after the procedure | Perform i-stat measurement (capillary pCO2 value in mmHg) | Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| To asses the change in waist circumference comparing CO2 and air insufflation | Perform waist measurements at the level of umbilicus with measuring tape in cm | at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matjaz Homan, PhD | Contact | 0038640885848 | matjaz.homan@guest.arnes.si | |
| Mike Thomson, PhD | Contact | 44 0114 271 7000 | mthomson221168@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Matjaz Homan, PhD | Children's Hospital in Ljubljana | Principal Investigator |
| Mike Thomson, PhD | Sheffield Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paediatric Gastroenterology-Hepatology, Queen Fabiola Children's University Hospital | Not yet recruiting | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6780678 | Result | Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x. | |
| 21245991 | Result | Thomson M, Rao P, Rawat D, Wenzl TG. Percutaneous endoscopic gastrostomy and gastro-oesophageal reflux in neurologically impaired children. World J Gastroenterol. 2011 Jan 14;17(2):191-6. doi: 10.3748/wjg.v17.i2.191. |
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to use REDCap platform (gender, age, weight, BMI, type of procedure, type of anestesia, type of the endoscopy, time of PEG insertion, underlining diseases, complications, stat, waist circumference)
after finishing the study to main investigators (2 years) for 1 months
principal investigators
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| ID | Term |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| air | Other | to insufflate air into the stomach instead of CO2 during the PEG |
|
| Children's Hospital Zagreb | Not yet recruiting | Zagreb | Croatia |
|
| Policlinico Universitario Messina | Not yet recruiting | Messina | Italy |
|
| University Children's Hospital | Recruiting | Ljubljana | 1000 | Slovenia |
|
| University Children's Hospital Basel | Not yet recruiting | Basel | Switzerland |
|
| Al Jalila Children's Specialty Hospital | Not yet recruiting | Dubai | United Arab Emirates |
|
| Sheffield Children's Hospital | Not yet recruiting | Sheffield | United Kingdom |
|
| 26363332 | Result | Homan M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10. |
| 19523621 | Result | Maple JT, Keswani RN, Hovis RM, Saddedin EZ, Jonnalagadda S, Azar RR, Hagen C, Thompson DM, Waldbaum L, Edmundowicz SA. Carbon dioxide insufflation during ERCP for reduction of postprocedure pain: a randomized, double-blind, controlled trial. Gastrointest Endosc. 2009 Aug;70(2):278-83. doi: 10.1016/j.gie.2008.12.050. Epub 2009 Jun 11. |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |