Clinical trial NCT03941522: Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
Official title: Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: loop ileostomy
diversion ileostomy
ileostomy closure
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total length of hospital stay
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Readmission rate
timeFrame: 30 days after surgery
measure: Postoperative complication rate
timeFrame: 30 days after surgery
measure: Postoperative ileus rate
timeFrame: 30 days after surgery
measure: Postoperative surgical site infection rate
timeFrame: 30 days after surgery
measure: Postoperative mortality rate
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Hôpital Saint-François d'Assise
state: Quebec
city: Québec
country: Canada
facility: Hôtel-Dieu de Québec
Study officials:
affiliation: CHU de Québec-Université Laval
name: François Letarte, MD, MSc
role: STUDY_DIRECTOR
affiliation: CHU de Québec-Université Laval
name: Xavier Paré, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec-Université Laval
name: Geneviève Morin, MD
role: PRINCIPAL_INVESTIGATOR
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