Ileostomy - StomaILEONCT03941522
Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
A study testing Early discharge from hospital in people with Ileostomy - Stoma, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Early discharge from hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2019to Jun 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hôpital Saint-François d'Assise
Québec, Quebec, G1L 3L5
Xavier Paré, MD, 418-684-7482, xavier.pare.2@ulaval.ca
Geneviève Morin, MD, 418-641-9284, genevieve.morin.27@ulaval.ca
Hôtel-Dieu de Québec
Québec, G1R 2J6
Xavier Paré, MD, 418-684-7482, xavier.pare.2@ulaval.ca
Geneviève Morin, MD, 418-641-9284, genevieve.morin.27@ulaval.ca
About this study
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.
Read the detailed description
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.
- Conditions
- Ileostomy - Stoma
- Being tested
- Early discharge from hospital
- Keywords
- loop ileostomy, diversion ileostomy, ileostomy closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early discharge from hospitalOther
Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (23-hour stay) | Experimental | Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria. Receives: Other: Early discharge from hospital |
| Control group (conventional hospitalization) | No intervention | Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of hospital stay
The number of days spent in the hospital from the time of the surgery to the time of the discharge as well as any day spent in the hospital after any readmission in the 30 days following the ileostomy closure.
Measured: 30 days after surgery
Secondary outcomes (5)
Readmission rate
Any hospitalisation after surgery
Measured: 30 days after surgery
Postoperative complication rate
Any complication after surgery
Measured: 30 days after surgery
Postoperative ileus rate
Ileus necessitating installation of a nasogastric tube
Measured: 30 days after surgery
Postoperative surgical site infection rate
Infection of the surgical site
Measured: 30 days after surgery
Postoperative mortality rate
Death after the surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study startJun 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Letarte, MD, MSc, Study director, CHU de Québec-Université LavalXavier Paré, MD, Principal investigator, CHU de Québec-Université LavalGeneviève Morin, MD, Principal investigator, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941522
- Sponsor's protocol ID
- 2019-4382
- Acronym
- ILEO
- Status last verified
- Jun 2019
- First submitted
- 6 May 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18580207Tan WS, Tang CL, Shi L, Eu KW. Meta-analysis of defunctioning stomas in low anterior resection for rectal cancer. Br J Surg. 2009 May;96(5):462-72. doi: 10.1002/bjs.6594.
PubMed 19358171Chen J, Wang DR, Yu HF, Zhao ZK, Wang LH, Li YK. Defunctioning stoma in low anterior resection for rectal cancer: a meta- analysis of five recent studies. Hepatogastroenterology. 2012 Sep;59(118):1828-31. doi: 10.5754/hge11786.
PubMed 22193436Koperna T. Cost-effectiveness of defunctioning stomas in low anterior resections for rectal cancer: a call for benchmarking. Arch Surg. 2003 Dec;138(12):1334-8; discussion 1339. doi: 10.1001/archsurg.138.12.1334.
PubMed 14662534Wong 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.
PubMed 15714246D'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.
PubMed 21780519Giannakopoulos 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.
PubMed 19175642Chow A, Tilney HS, Paraskeva P, Jeyarajah S, Zacharakis E, Purkayastha S. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis. 2009 Jun;24(6):711-23. doi: 10.1007/s00384-009-0660-z. Epub 2009 Feb 17.
PubMed 19221766Loffler 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.
PubMed 23095628Luglio 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.
PubMed 22006879Hiranyakas 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.
PubMed 22752281Mengual-Ballester M, Garcia-Marin JA, Pellicer-Franco E, Guillen-Paredes MP, Garcia-Garcia ML, Cases-Baldo MJ, Aguayo-Albasini JL. Protective ileostomy: complications and mortality associated with its closure. Rev Esp Enferm Dig. 2012 Jul;104(7):350-4. doi: 10.4321/s1130-01082012000700003.
PubMed 22849495Gong J, Guo Z, Li Y, Gu L, Zhu W, Li J, Li N. Stapled vs hand suture closure of loop ileostomy: a meta-analysis. Colorectal Dis. 2013;15(10):e561-8. doi: 10.1111/codi.12388.
PubMed 24033921Peacock 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.
PubMed 22936588Peacock 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.
PubMed 22033543
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03941522
- Acronym / sponsor ID
- ILEO / 2019-4382
- Conditions
- Ileostomy - Stoma
- Keywords
- loop ileostomy, diversion ileostomy, ileostomy closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 May 2019 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (23-hour stay) | Experimental | Other: Early discharge from hospitalPatients 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) | No intervention | –Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Language barrier or significant communication problem
- Immunosuppression
- Therapeutic anticoagulation
- Previous proctocolectomy
- Previous ileal pouch anal anastomosis
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 |
|---|---|---|
| Early discharge from hospitalPatients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria. | Other | Intervention group (23-hour stay) |
Primary outcome
Total length of hospital stay
Time frame: 30 days after surgery
The number of days spent in the hospital from the time of the surgery to the time of the discharge as well as any day spent in the hospital after any readmission in the 30 days following the ileostomy closure.
5 secondary outcomes
Readmission rate
Time frame: 30 days after surgery
Postoperative complication rate
Time frame: 30 days after surgery
Postoperative ileus rate
Time frame: 30 days after surgery
Postoperative surgical site infection rate
Time frame: 30 days after surgery
Postoperative mortality rate
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Results publication: PubMed 18580207Huser 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.
- Results publication: PubMed 19358171Tan WS, Tang CL, Shi L, Eu KW. Meta-analysis of defunctioning stomas in low anterior resection for rectal cancer. Br J Surg. 2009 May;96(5):462-72. doi: 10.1002/bjs.6594.
- Results publication: PubMed 22193436Chen J, Wang DR, Yu HF, Zhao ZK, Wang LH, Li YK. Defunctioning stoma in low anterior resection for rectal cancer: a meta- analysis of five recent studies. Hepatogastroenterology. 2012 Sep;59(118):1828-31. doi: 10.5754/hge11786.
- Results publication: PubMed 14662534Koperna T. Cost-effectiveness of defunctioning stomas in low anterior resections for rectal cancer: a call for benchmarking. Arch Surg. 2003 Dec;138(12):1334-8; discussion 1339. doi: 10.1001/archsurg.138.12.1334.
- Results publication: PubMed 15714246Wong 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.
- Results publication: PubMed 21780519D'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.
- Results publication: PubMed 19175642Giannakopoulos 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.
- Results publication: PubMed 19221766Chow A, Tilney HS, Paraskeva P, Jeyarajah S, Zacharakis E, Purkayastha S. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis. 2009 Jun;24(6):711-23. doi: 10.1007/s00384-009-0660-z. Epub 2009 Feb 17.
- Results publication: PubMed 23095628Loffler 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.
- Results publication: PubMed 22006879Luglio 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.
- Results publication: PubMed 22752281Hiranyakas 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.
- Results publication: PubMed 22849495Mengual-Ballester M, Garcia-Marin JA, Pellicer-Franco E, Guillen-Paredes MP, Garcia-Garcia ML, Cases-Baldo MJ, Aguayo-Albasini JL. Protective ileostomy: complications and mortality associated with its closure. Rev Esp Enferm Dig. 2012 Jul;104(7):350-4. doi: 10.4321/s1130-01082012000700003.
- Individual participant dataSharing planned: No
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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.
François Letarte, MD, MSc study director
CHU de Québec-Université Laval
Xavier Paré, MD principal investigator
CHU de Québec-Université Laval
Geneviève Morin, MD principal investigator
CHU de Québec-Université Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early discharge from hospital in people with Ileostomy - Stoma, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Paré, MD (418-684-7482, xavier.pare.2@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of hospital stay (time frame: 30 days after surgery). 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 NCT03941522, which also lists 34 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 12 Jun 2019.