Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
NCT ID: NCT03941522
Last Updated: 2019-06-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
168 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-06-30
Study Completion Date
2021-06-30
Brief Summary
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The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.
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Detailed Description
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Rationale :
Loop ileostomy is defined by bringing a loop of small bowel out onto the surface of the skin to allow diversion of the fecal stream. It is a common procedure that is conjointly done with colorectal surgeries with the objective to protect intestinal anastomosis at high risk of leaking. Loop ileostomy closure is then performed in the months following the initial surgery when the anastomosis has healed. Often thought of as a simple procedure, it is still associated with a significant postoperative morbidity rate consisting mostly of postoperative ileus. In the CHU de Québec-Université Laval, patients are hospitalized for a median of five days until their bowels open up while no active care is given. This represents 645 days of hospitalization each year for Hôpital Saint-François d'Assise (HSFA), Hôtel-Dieu de Québec (HDQ) and Centre Hospitalier de l'Université Laval (CHUL). Hence, there is a clear need to determine if the investigator can improve the outcomes following ileostomy closure by applying a standardized enhanced recovery pathway specific to ileostomy closure to the point where the surgery can be performed in a twenty-three hours hospitalization setting.
Objective :
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.
Hypothesis :
The investigator believes patients randomized to the group 23-hour stay will have reduced total length of hospital stay compared to patients randomized to the group conventional hospitalization after ileostomy closure.
Methods :
Healthy adults (ASA I and II) undergoing elective ileostomy closure who consented to take part in the study will be enrolled in a standardized enhanced recovery pathway specific to ileostomy closure. Once surgery is completed, they will be randomized to either 23-hour stay or conventional hospitalization. Data on postoperative outcomes will be gathered prospectively until 30 days after surgery and will include total length of hospital stay in days, readmissions, postoperative complications, more precisely postoperative ileus and surgical site infections, as well as mortality.
Clinical significance :
If safety and feasibility of a fast discharge of patients is demonstrated by this study, it would then mean that patients could be discharged from hospital less than 24 hours after a loop ileostomy closure. It could potentially lower the consequences of a long hospital stay for patients, such as risks of nosocomial infections, thromboembolic events, and hospital acquired autonomy loss.
Loop ileostomy is defined by bringing a loop of small bowel out onto the surface of the skin to allow diversion of the fecal stream. It is a common procedure that is conjointly done with colorectal surgeries with the objective to protect intestinal anastomosis at high risk of leaking. Loop ileostomy closure is then performed in the months following the initial surgery when the anastomosis has healed. Often thought of as a simple procedure, it is still associated with a significant postoperative morbidity rate consisting mostly of postoperative ileus. In the CHU de Québec-Université Laval, patients are hospitalized for a median of five days until their bowels open up while no active care is given. This represents 645 days of hospitalization each year for Hôpital Saint-François d'Assise (HSFA), Hôtel-Dieu de Québec (HDQ) and Centre Hospitalier de l'Université Laval (CHUL). Hence, there is a clear need to determine if the investigator can improve the outcomes following ileostomy closure by applying a standardized enhanced recovery pathway specific to ileostomy closure to the point where the surgery can be performed in a twenty-three hours hospitalization setting.
Objective :
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.
Hypothesis :
The investigator believes patients randomized to the group 23-hour stay will have reduced total length of hospital stay compared to patients randomized to the group conventional hospitalization after ileostomy closure.
Methods :
Healthy adults (ASA I and II) undergoing elective ileostomy closure who consented to take part in the study will be enrolled in a standardized enhanced recovery pathway specific to ileostomy closure. Once surgery is completed, they will be randomized to either 23-hour stay or conventional hospitalization. Data on postoperative outcomes will be gathered prospectively until 30 days after surgery and will include total length of hospital stay in days, readmissions, postoperative complications, more precisely postoperative ileus and surgical site infections, as well as mortality.
Clinical significance :
If safety and feasibility of a fast discharge of patients is demonstrated by this study, it would then mean that patients could be discharged from hospital less than 24 hours after a loop ileostomy closure. It could potentially lower the consequences of a long hospital stay for patients, such as risks of nosocomial infections, thromboembolic events, and hospital acquired autonomy loss.
Conditions
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Ileostomy - Stoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Intervention group (23-hour stay)
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
Group Type
EXPERIMENTAL
Early discharge from hospital
Intervention Type
OTHER
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
Control group (conventional hospitalization)
Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Early discharge from hospital
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years and older
* Able to provide informed consent
* ASA I and II (American Society of Anesthesiologists)
* Staying less than 50 kilometers from a hospital after surgery
* Being accompanied by an adult able to assist the patient in his recovery and to intervene in case of an emergency for the first 48 hours after surgery
* No anastomotic leak proven on preoperative water soluble enema
* Able to provide informed consent
* ASA I and II (American Society of Anesthesiologists)
* Staying less than 50 kilometers from a hospital after surgery
* Being accompanied by an adult able to assist the patient in his recovery and to intervene in case of an emergency for the first 48 hours after surgery
* No anastomotic leak proven on preoperative water soluble enema
Exclusion Criteria
* Language barrier or significant communication problem
* Immunosuppression
* Therapeutic anticoagulation
* Previous proctocolectomy
* Previous ileal pouch anal anastomosis
* Technical factors during surgery (conversion to midline laparotomy or other, at surgeon's discretion)
* Immunosuppression
* Therapeutic anticoagulation
* Previous proctocolectomy
* Previous ileal pouch anal anastomosis
* Technical factors during surgery (conversion to midline laparotomy or other, at surgeon's discretion)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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François Letarte, MD, MSc
Role: STUDY_DIRECTOR
CHU de Québec-Université Laval
Xavier Paré, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Québec-Université Laval
Geneviève Morin, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Québec-Université Laval
Locations
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Hôpital Saint-François d'Assise
Québec, Quebec, Canada
Site Status
Hôtel-Dieu de Québec
Québec, , Canada
Site Status
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Huser N, Michalski CW, Erkan M, Schuster T, Rosenberg R, Kleeff J, Friess H. Systematic review and meta-analysis of the role of defunctioning stoma in low rectal cancer surgery. Ann Surg. 2008 Jul;248(1):52-60. doi: 10.1097/SLA.0b013e318176bf65.
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Wong KS, Remzi FH, Gorgun E, Arrigain S, Church JM, Preen M, Fazio VW. Loop ileostomy closure after restorative proctocolectomy: outcome in 1,504 patients. Dis Colon Rectum. 2005 Feb;48(2):243-50. doi: 10.1007/s10350-004-0771-0.
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D'Haeninck A, Wolthuis AM, Penninckx F, D'Hondt M, D'Hoore A. Morbidity after closure of a defunctioning loop ileostomy. Acta Chir Belg. 2011 May-Jun;111(3):136-41. doi: 10.1080/00015458.2011.11680724.
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Giannakopoulos GF, Veenhof AA, van der Peet DL, Sietses C, Meijerink WJ, Cuesta MA. Morbidity and complications of protective loop ileostomy. Colorectal Dis. 2009 Jul;11(6):609-12. doi: 10.1111/j.1463-1318.2008.01690.x. Epub 2008 Oct 1.
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Loffler T, Rossion I, Bruckner T, Diener MK, Koch M, von Frankenberg M, Pochhammer J, Thomusch O, Kijak T, Simon T, Mihaljevic AL, Kruger M, Stein E, Prechtl G, Hodina R, Michal W, Strunk R, Henkel K, Bunse J, Jaschke G, Politt D, Heistermann HP, Fusser M, Lange C, Stamm A, Vosschulte A, Holzer R, Partecke LI, Burdzik E, Hug HM, Luntz SP, Kieser M, Buchler MW, Weitz J; HASTA Trial Group. HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040). Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97.
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Luglio G, Pendlimari R, Holubar SD, Cima RR, Nelson H. Loop ileostomy reversal after colon and rectal surgery: a single institutional 5-year experience in 944 patients. Arch Surg. 2011 Oct;146(10):1191-6. doi: 10.1001/archsurg.2011.234.
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Hiranyakas A, Rather A, da Silva G, Weiss EG, Wexner SD. Loop ileostomy closure after laparoscopic versus open surgery: is there a difference? Surg Endosc. 2013 Jan;27(1):90-4. doi: 10.1007/s00464-012-2422-1. Epub 2012 Jun 30.
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Peacock O, Bhalla A, Simpson JA, Gold S, Hurst NG, Speake WJ, Tierney GM, Lund JN. Twenty-three-hour stay loop ileostomy closures: a pilot study. Tech Coloproctol. 2013 Feb;17(1):45-9. doi: 10.1007/s10151-012-0880-z. Epub 2012 Aug 31.
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Peacock O, Law CI, Collins PW, Speake WJ, Lund JN, Tierney GM. Closure of loop ileostomy: potentially a daycase procedure? Tech Coloproctol. 2011 Dec;15(4):431-7. doi: 10.1007/s10151-011-0781-6. Epub 2011 Oct 28.
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Baraza W, Wild J, Barber W, Brown S. Postoperative management after loop ileostomy closure: are we keeping patients in hospital too long? Ann R Coll Surg Engl. 2010 Jan;92(1):51-5. doi: 10.1308/003588410X12518836439209.
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Bhalla A, Peacock O, Tierney GM, Tou S, Hurst NG, Speake WJ, Williams JP, Lund JN. Day-case closure of ileostomy: feasible, safe and efficient. Colorectal Dis. 2015 Sep;17(9):820-3. doi: 10.1111/codi.12961.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-4382
Identifier Type: -
Identifier Source: org_study_id
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