Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial

Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who...

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Veröffentlicht in:Surgical endoscopy 2023-05, Vol.37 (5), p.3934-3943
Hauptverfasser: Garfinkle, Richard, Demian, Marie, Sabboobeh, Sarah, Moon, Jeongyoon, Hulme-Moir, Michael, Liberman, A. Sender, Feinberg, Stan, Hayden, Dana M., Chadi, Sami A., Demyttenaere, Sebastian, Samuel, Louise, Hotakorzian, Nevart, Quintin, Laurence, Morin, Nancy, Faria, Julio, Ghitulescu, Gabriela, Vasilevsky, Carol-Ann, Boutros, Marylise
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container_end_page 3943
container_issue 5
container_start_page 3934
container_title Surgical endoscopy
container_volume 37
creator Garfinkle, Richard
Demian, Marie
Sabboobeh, Sarah
Moon, Jeongyoon
Hulme-Moir, Michael
Liberman, A. Sender
Feinberg, Stan
Hayden, Dana M.
Chadi, Sami A.
Demyttenaere, Sebastian
Samuel, Louise
Hotakorzian, Nevart
Quintin, Laurence
Morin, Nancy
Faria, Julio
Ghitulescu, Gabriela
Vasilevsky, Carol-Ann
Boutros, Marylise
description Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/vomiting, abdominal distension, or the absence of flatus. Results Between January 2017 and November 2020, 101 patients were randomized, and 5 patients never underwent ileostomy closure; thus, 96 patients (47 stimulated vs. 49 control) were analyzed according to a modified intention-to-treat protocol. Baseline characteristics were well balanced in both groups. The incidence of POI was lower among patients randomized to stimulation (6.4% vs. 24.5%, p  = 0.034; unadjusted RR: 0.26, 95% CI 0.078–0.87). Stimulated patients also had earlier median time to first flatus (2.0 days (1.0–2.0) vs. 2.0 days (2.0–3.0), p  = 0.025), were more likely to pass flatus on postoperative day 1 (46.8% vs. 22.4%, p  = 0.022), and had a shorter median postoperative hospital stay (3.0 days (2.0–3.5) vs. 4.0 days (2.0–6.0), p  = 0.003). Conclusions Preoperative bowel stimulation via the efferent limb of the ileostomy reduced POI after elective loop ileostomy closure.
doi_str_mv 10.1007/s00464-022-09510-5
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Sender ; Feinberg, Stan ; Hayden, Dana M. ; Chadi, Sami A. ; Demyttenaere, Sebastian ; Samuel, Louise ; Hotakorzian, Nevart ; Quintin, Laurence ; Morin, Nancy ; Faria, Julio ; Ghitulescu, Gabriela ; Vasilevsky, Carol-Ann ; Boutros, Marylise</creator><creatorcontrib>Garfinkle, Richard ; Demian, Marie ; Sabboobeh, Sarah ; Moon, Jeongyoon ; Hulme-Moir, Michael ; Liberman, A. Sender ; Feinberg, Stan ; Hayden, Dana M. ; Chadi, Sami A. ; Demyttenaere, Sebastian ; Samuel, Louise ; Hotakorzian, Nevart ; Quintin, Laurence ; Morin, Nancy ; Faria, Julio ; Ghitulescu, Gabriela ; Vasilevsky, Carol-Ann ; Boutros, Marylise ; Bowel Stimulation Research Collaborative</creatorcontrib><description>Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/vomiting, abdominal distension, or the absence of flatus. Results Between January 2017 and November 2020, 101 patients were randomized, and 5 patients never underwent ileostomy closure; thus, 96 patients (47 stimulated vs. 49 control) were analyzed according to a modified intention-to-treat protocol. Baseline characteristics were well balanced in both groups. The incidence of POI was lower among patients randomized to stimulation (6.4% vs. 24.5%, p  = 0.034; unadjusted RR: 0.26, 95% CI 0.078–0.87). Stimulated patients also had earlier median time to first flatus (2.0 days (1.0–2.0) vs. 2.0 days (2.0–3.0), p  = 0.025), were more likely to pass flatus on postoperative day 1 (46.8% vs. 22.4%, p  = 0.022), and had a shorter median postoperative hospital stay (3.0 days (2.0–3.5) vs. 4.0 days (2.0–6.0), p  = 0.003). Conclusions Preoperative bowel stimulation via the efferent limb of the ileostomy reduced POI after elective loop ileostomy closure.</description><identifier>ISSN: 0930-2794</identifier><identifier>EISSN: 1432-2218</identifier><identifier>DOI: 10.1007/s00464-022-09510-5</identifier><identifier>PMID: 35984521</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>2022 SAGES Oral ; Abdomen ; Abdominal Surgery ; Adolescent ; Adult ; Clinical trials ; Endoscopy ; Flatulence - complications ; Gastroenterology ; Gynecology ; Hepatology ; Hospitals ; Humans ; Ileostomy - methods ; Ileus - epidemiology ; Ileus - etiology ; Ileus - prevention &amp; control ; Intervention ; Intestines ; Length of stay ; Medicine ; Medicine &amp; Public Health ; Ostomy ; Patients ; Postoperative Complications - epidemiology ; Postoperative Complications - etiology ; Postoperative Complications - prevention &amp; control ; Postoperative period ; Proctology ; Surgery</subject><ispartof>Surgical endoscopy, 2023-05, Vol.37 (5), p.3934-3943</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><rights>The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-d39346c27c9a1cd9e4c822605d1289c14318bebc91f89f343fc4531ec9b03b413</citedby><cites>FETCH-LOGICAL-c474t-d39346c27c9a1cd9e4c822605d1289c14318bebc91f89f343fc4531ec9b03b413</cites><orcidid>0000-0001-8006-321X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00464-022-09510-5$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00464-022-09510-5$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35984521$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Garfinkle, Richard</creatorcontrib><creatorcontrib>Demian, Marie</creatorcontrib><creatorcontrib>Sabboobeh, Sarah</creatorcontrib><creatorcontrib>Moon, Jeongyoon</creatorcontrib><creatorcontrib>Hulme-Moir, Michael</creatorcontrib><creatorcontrib>Liberman, A. Sender</creatorcontrib><creatorcontrib>Feinberg, Stan</creatorcontrib><creatorcontrib>Hayden, Dana M.</creatorcontrib><creatorcontrib>Chadi, Sami A.</creatorcontrib><creatorcontrib>Demyttenaere, Sebastian</creatorcontrib><creatorcontrib>Samuel, Louise</creatorcontrib><creatorcontrib>Hotakorzian, Nevart</creatorcontrib><creatorcontrib>Quintin, Laurence</creatorcontrib><creatorcontrib>Morin, Nancy</creatorcontrib><creatorcontrib>Faria, Julio</creatorcontrib><creatorcontrib>Ghitulescu, Gabriela</creatorcontrib><creatorcontrib>Vasilevsky, Carol-Ann</creatorcontrib><creatorcontrib>Boutros, Marylise</creatorcontrib><creatorcontrib>Bowel Stimulation Research Collaborative</creatorcontrib><title>Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial</title><title>Surgical endoscopy</title><addtitle>Surg Endosc</addtitle><addtitle>Surg Endosc</addtitle><description>Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/vomiting, abdominal distension, or the absence of flatus. Results Between January 2017 and November 2020, 101 patients were randomized, and 5 patients never underwent ileostomy closure; thus, 96 patients (47 stimulated vs. 49 control) were analyzed according to a modified intention-to-treat protocol. Baseline characteristics were well balanced in both groups. The incidence of POI was lower among patients randomized to stimulation (6.4% vs. 24.5%, p  = 0.034; unadjusted RR: 0.26, 95% CI 0.078–0.87). Stimulated patients also had earlier median time to first flatus (2.0 days (1.0–2.0) vs. 2.0 days (2.0–3.0), p  = 0.025), were more likely to pass flatus on postoperative day 1 (46.8% vs. 22.4%, p  = 0.022), and had a shorter median postoperative hospital stay (3.0 days (2.0–3.5) vs. 4.0 days (2.0–6.0), p  = 0.003). 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Sender ; Feinberg, Stan ; Hayden, Dana M. ; Chadi, Sami A. ; Demyttenaere, Sebastian ; Samuel, Louise ; Hotakorzian, Nevart ; Quintin, Laurence ; Morin, Nancy ; Faria, Julio ; Ghitulescu, Gabriela ; Vasilevsky, Carol-Ann ; Boutros, Marylise</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-d39346c27c9a1cd9e4c822605d1289c14318bebc91f89f343fc4531ec9b03b413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>2022 SAGES Oral</topic><topic>Abdomen</topic><topic>Abdominal Surgery</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Clinical trials</topic><topic>Endoscopy</topic><topic>Flatulence - complications</topic><topic>Gastroenterology</topic><topic>Gynecology</topic><topic>Hepatology</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Ileostomy - methods</topic><topic>Ileus - epidemiology</topic><topic>Ileus - etiology</topic><topic>Ileus - prevention &amp; control</topic><topic>Intervention</topic><topic>Intestines</topic><topic>Length of stay</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Ostomy</topic><topic>Patients</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - etiology</topic><topic>Postoperative Complications - prevention &amp; control</topic><topic>Postoperative period</topic><topic>Proctology</topic><topic>Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Garfinkle, Richard</creatorcontrib><creatorcontrib>Demian, Marie</creatorcontrib><creatorcontrib>Sabboobeh, Sarah</creatorcontrib><creatorcontrib>Moon, Jeongyoon</creatorcontrib><creatorcontrib>Hulme-Moir, Michael</creatorcontrib><creatorcontrib>Liberman, A. 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Sender</au><au>Feinberg, Stan</au><au>Hayden, Dana M.</au><au>Chadi, Sami A.</au><au>Demyttenaere, Sebastian</au><au>Samuel, Louise</au><au>Hotakorzian, Nevart</au><au>Quintin, Laurence</au><au>Morin, Nancy</au><au>Faria, Julio</au><au>Ghitulescu, Gabriela</au><au>Vasilevsky, Carol-Ann</au><au>Boutros, Marylise</au><aucorp>Bowel Stimulation Research Collaborative</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial</atitle><jtitle>Surgical endoscopy</jtitle><stitle>Surg Endosc</stitle><addtitle>Surg Endosc</addtitle><date>2023-05-01</date><risdate>2023</risdate><volume>37</volume><issue>5</issue><spage>3934</spage><epage>3943</epage><pages>3934-3943</pages><issn>0930-2794</issn><eissn>1432-2218</eissn><abstract>Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/vomiting, abdominal distension, or the absence of flatus. Results Between January 2017 and November 2020, 101 patients were randomized, and 5 patients never underwent ileostomy closure; thus, 96 patients (47 stimulated vs. 49 control) were analyzed according to a modified intention-to-treat protocol. Baseline characteristics were well balanced in both groups. The incidence of POI was lower among patients randomized to stimulation (6.4% vs. 24.5%, p  = 0.034; unadjusted RR: 0.26, 95% CI 0.078–0.87). Stimulated patients also had earlier median time to first flatus (2.0 days (1.0–2.0) vs. 2.0 days (2.0–3.0), p  = 0.025), were more likely to pass flatus on postoperative day 1 (46.8% vs. 22.4%, p  = 0.022), and had a shorter median postoperative hospital stay (3.0 days (2.0–3.5) vs. 4.0 days (2.0–6.0), p  = 0.003). Conclusions Preoperative bowel stimulation via the efferent limb of the ileostomy reduced POI after elective loop ileostomy closure.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>35984521</pmid><doi>10.1007/s00464-022-09510-5</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8006-321X</orcidid><oa>free_for_read</oa></addata></record>
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subjects 2022 SAGES Oral
Abdomen
Abdominal Surgery
Adolescent
Adult
Clinical trials
Endoscopy
Flatulence - complications
Gastroenterology
Gynecology
Hepatology
Hospitals
Humans
Ileostomy - methods
Ileus - epidemiology
Ileus - etiology
Ileus - prevention & control
Intervention
Intestines
Length of stay
Medicine
Medicine & Public Health
Ostomy
Patients
Postoperative Complications - epidemiology
Postoperative Complications - etiology
Postoperative Complications - prevention & control
Postoperative period
Proctology
Surgery
title Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial
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