Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial

Ileostomy - Stoma Clinical Trial

— ILEO  

Official title:

Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03941522
• Other study ID #: 2019-4382
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2019
• Est. completion date: June 2021

Study information

• Verified date: June 2019
• Source: CHU de Quebec-Universite Laval
• Contact: Xavier Paré, MD
• Phone: 418-684-7482
• Email: xavier.pare.2[@]ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

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.

Locations

Country	Name	City	State
Canada	Hôpital Saint-François d'Assise	Québec	Quebec
Canada	Hôtel-Dieu de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days after surgery
Secondary	Readmission rate	Any hospitalisation after surgery	30 days after surgery
Secondary	Postoperative complication rate	Any complication after surgery	30 days after surgery
Secondary	Postoperative ileus rate	Ileus necessitating installation of a nasogastric tube	30 days after surgery
Secondary	Postoperative surgical site infection rate	Infection of the surgical site	30 days after surgery
Secondary	Postoperative mortality rate	Death after the surgery	30 days after surgery