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Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial (ILEO)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ileostomy - Stoma | Other: Early discharge from hospital | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 168 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial |
| Estimated Study Start Date : | June 2019 |
| Estimated Primary Completion Date : | April 2021 |
| Estimated Study Completion Date : | June 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
Other: 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.
|
|
No Intervention: Control group (conventional hospitalization)
Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure.
|
- 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.
- Readmission rate [ Time Frame: 30 days after surgery ]Any hospitalisation after surgery
- Postoperative complication rate [ Time Frame: 30 days after surgery ]Any complication after surgery
- Postoperative ileus rate [ Time Frame: 30 days after surgery ]Ileus necessitating installation of a nasogastric tube
- Postoperative surgical site infection rate [ Time Frame: 30 days after surgery ]Infection of the surgical site
- Postoperative mortality rate [ Time Frame: 30 days after surgery ]Death after the surgery
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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)
| Contact: Xavier Paré, MD | 418-684-7482 | xavier.pare.2@ulaval.ca | |
| Contact: Geneviève Morin, MD | 418-641-9284 | genevieve.morin.27@ulaval.ca |
| Canada, Quebec | |
| Hôpital Saint-François d'Assise | |
| Québec, Quebec, Canada, G1L 3L5 | |
| Contact: Xavier Paré, MD 418-684-7482 xavier.pare.2@ulaval.ca | |
| Contact: Geneviève Morin, MD 418-641-9284 genevieve.morin.27@ulaval.ca | |
| Principal Investigator: Xavier Paré, MD | |
| Principal Investigator: Geneviève Morin, MD | |
| Canada | |
| Hôtel-Dieu de Québec | |
| Québec, Canada, G1R 2J6 | |
| Contact: Xavier Paré, MD 418-684-7482 xavier.pare.2@ulaval.ca | |
| Contact: Geneviève Morin, MD 418-641-9284 genevieve.morin.27@ulaval.ca | |
| Principal Investigator: Xavier Paré, MD | |
| Principal Investigator: Geneviève Morin, MD | |
| Study Director: | François Letarte, MD, MSc | CHU de Québec-Université Laval | |
| Principal Investigator: | Xavier Paré, MD | CHU de Québec-Université Laval | |
| Principal Investigator: | Geneviève Morin, MD | CHU de Québec-Université Laval |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 6, 2019 | |||||||||
| First Posted Date ICMJE | May 8, 2019 | |||||||||
| Last Update Posted Date | June 12, 2019 | |||||||||
| Estimated Study Start Date ICMJE | June 2019 | |||||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial | |||||||||
| Official Title ICMJE | Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial | |||||||||
| Brief 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 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. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE | Ileostomy - Stoma | |||||||||
| Intervention ICMJE | Other: 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.
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Estimated Enrollment ICMJE |
168 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | June 2021 | |||||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Canada | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03941522 | |||||||||
| Other Study ID Numbers ICMJE | 2019-4382 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | CHU de Quebec-Universite Laval | |||||||||
| Study Sponsor ICMJE | CHU de Quebec-Universite Laval | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | CHU de Quebec-Universite Laval | |||||||||
| Verification Date | June 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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