Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial
Phase: NA
Conditions: Ileostomy - Stoma
Sponsor: CHU de Quebec-Universite Laval

LOOP ILEOSTOMY CLOSURE AS A 23-HOUR STAY PROCEDURE, A 
MULTI-CENTER RANDOMIZED CLINICAL TRIAL 
Xavier Paré, MD 
Co-Author 
Geneviève Morin, MD 
Co-Author 
Dr François Letarte, MD, MSc, FRCSC 
Primary Investigator 
Dr Sébastien Drolet, MD, MSc, FRCSC 
Co-investigator 
CHU de Québec-Université Laval 
May 6th 2019

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Abstract 
 
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 we 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 :  
We believe 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.  
 
 
1. Background and rationale 
 

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1.1 Introduction 
Loop ileostomy, defined by securing a loop of small bowel onto the surface of the skin and creating 
an opening to allow enteric content to be collected in an artificial outpouching system, is a 
procedure that is frequently done conjointly with colorectal cancer surgery. The objective is to 
protect distal colonic anastomoses, connections between the colon and the rectum or the anus, that 
are at risk of leakage in the postoperative period. Even though they do not reduce the total incidence 
of anastomotic leaks, they contribute in reducing the clinical consequences (1-3). Loop ileostomy 
are designed to be temporary and once the anastomosis has proven to have healed adequately, 
ileostomy closure can be scheduled. Often thought of as a simple procedure, loop ileostomy closure 
is associated with morbidity rates ranging from 11% to 45% (4-7). A systematic review by Chow 
et al. identified 48 studies including 6,107 cases of ileostomy closure (8). They found a 17.3% rate 
of overall morbidity with postoperative obstruction (7.2%) and surgical site infection (5.0%) being 
the most common complications (8). Anastomotic leak rate was found to be 1.2% while mortality 
rate was 0.4% (8). The average length of hospital stay in this review was 5.1 days (8).   
Postoperative ileus is defined as obstipation and intolerance of oral intake due to non-mechanical 
factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract 
following abdominal surgery. Studies of patients treated by ileostomy closure report highly 
variable postoperative ileus rates, ranging from 8-32% (5-6, 8-13). Postoperative ileus is the 
primary reason for admission to hospital for most patients after ileostomy closure. 
 
1.2 St. Paul’s Hospital experience 
St. Paul’s Hospital in Vancouver and Hôpital Saint-François d’Assise in Quebec City are two 
tertiary care centers with similar colorectal surgical practices and patient populations. While doing 
a fellowship there, Dr François Letarte, senior author in this study, made a retrospective study on 
loop ileostomy closures in this center.   
The preliminary analysis of data at St. Paul’s Hospital was made through a retrospective review of 
all cases of ileostomy closure done at this site between January 2007 and April 2015. During that 
time, 496 cases of elective ileostomy closure were performed. The median length of hospital stay 
was four days and the median time to return of bowel function was two days. Overall morbidity 
rate was estimated at 26.3% with a 14.1% postoperative ileus rate and surgical site infection rate 
of 6.0%. The 30-day mortality rate in this series was 1.0% and the 30-day readmission rate was 
6.7%.  
 
1.3 Moving toward shorter hospital stay 
In the past decade, surgeons have started to question whether keeping patients in the hospital after 
loop ileostomy closure is necessary. In the United Kingdom, Peacock et al. studied 4463 cases of 
loop ileostomy closure performed in 2013, a median length of hospital stay of five days was 
observed, accounting for 36 000 bed days annually (14). The majority of these patients are 
hospitalized until their bowel function returns while no active treatment is being performed (14). 
When complications occur, they are either apparent immediately after surgery or manifest 
themselves several days after surgery (15). Baraza et al. reviewed their hospital experience with 
ileostomy closure and analyzed 80 consecutive patients (16). While they found that 25% of patients 
experienced postoperative morbidity, over 70% of the complications were considered minor and 
could have been treated in an outpatient setting (16). Consistent with this assertion, the readmission 
rate was only 2.5% (16). Therefore, the authors concluded that there was no reason to keep patient 
hospitalized until their bowel function returned (16).  
Joh et al. at Case Medical Center in Cleveland evaluated the role of a standardized care pathway 
adapted for ileostomy closure to see how it affected the outcomes (17). They were able to reduce 

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their length of stay to a median of two days with a readmission rate of 9.4% (17). Similarly, two 
other groups developed protocols where ileostomy closure patients were released from the hospital 
after a 23-hour observation period (18-19). Although these two studies were small case-series, they 
showed acceptable results with limited complications rates of less than 10% and low readmission 
rates of less than 5% (18-19). Finally, a pilot study of 15 patients who had ileostomy closure and 
were discharged from the hospital on the same day was published (20). Only two patients 
experienced minor complications and no readmissions were warranted (20). 
 
1.4 Technical innovations to improve outcomes after ileostomy closure 
A systematic review and meta-analysis also reviewed sutured versus stapled anastomosis for 
ileostomy closure and found that stapled anastomosis were less likely to present with postoperative 
small bowel obstruction and were associated with a decreased operating time when compared to 
sutured anastomosis (21). A systematic review and meta-analysis comparing purse-string closure 
and conventional linear closure of the wound of the ancient ileostomy site showed a 90% reduced 
risk of surgical site infection when using purse-string closure (22).  
 
1.5 Reducing postoperative ileus rates 
Postoperative ileus remains a significant factor affecting the length of stay after colorectal surgery. 
The advent of enhanced recovery after surgery programs has been advocated as a means of safely 
reducing the length of stay and improving the overall perioperative care for patients undergoing 
colectomy (17, 23-24). ERAS programs are meant to address the surgical stress response and 
reduce predictable complications so that the inefficiency of care can be reduced (17, 23-24). 
Prevention of postoperative ileus is important because this complication is a  major cause of 
delayed discharge after abdominal surgery (25-27). A systematic review and meta-analysis 
performed by Adamina et al. reviewed six randomized trials on ERAS programs after colorectal 
surgery (24). They found that enhanced recovery pathway was associated with a shorter duration 
of hospital stay in patients who underwent major colorectal surgery and reduced 30-day morbidity 
(24). There was no effect on readmission compared to traditional care (24). 
As mentioned earlier, postoperative ileus is the most frequent complication encountered in patients 
undergoing ileostomy closure in most studies. This was also true for the patients of St. Paul's 
Hospital mentioned in section 1.2 with a rate of 14.1%. One randomized controlled trial from Spain 
was able to significantly decrease the rate of postoperative ileus from 20% to 2.85% using 
preoperative stimulation of the efferent limb (27). Patients were injected a solution of normal saline 
and a thickening agent through the efferent limb of the ileostomy once a day for 14 days prior to 
surgery (27). The theory behind this intervention is that when the colon is diverted with a loop 
ileostomy, diversion colitis will develop in most patients (27). This could explain in part why once 
the ileostomy is closed and the flow of feces is re-established, patients have a tendency to 
experience ileus or diarrhea (27). By stimulating the efferent limb of the ileostomy and by 
consequence the colon prior to surgery, this could decrease the inflammation, increase absorption 
by the colon and reduce the time to return of bowel function (27). We believe the irrigation of the 
efferent limb with an enteral nutritional formula would be even more efficient to alleviate diversion 
colitis and remove mucous plug in the colon which could lead to decreased postoperative ileus 
rates and faster return of bowel function after ileostomy closure. This use of enteral nutritional 
formula in the distal portion of the bowel (terminal ileum/colon) is a practice derived from 
jejunostomy tube feeding. 
 
1.6 Standardized enhanced recovery pathway for ileostomy closure 

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Recently, a standardized enhanced recovery pathway specific to ileostomy closure was developed 
in our center and aims to decrease length of hospital stay, readmission rate, postoperative ileus rate 
and postoperative complication rate. It includes early feeding and ambulation and early discharge 
from the hospital as soon as patients meet the pre-established criteria. For this study, preoperative 
efferent limb stimulation will be added to the enhanced recovery pathway. Hence, all participants 
of the study will be included in the enhanced recovery pathway with efferent limb stimulation. 
 
1.7 Summary  
In summary, ileostomy closure is a common procedure that is associated with significant rates of 
postoperative morbidity leading to long hospitalizations. However, it seems that the majority of 
these complications are minor and potentially preventable or avoidable. A randomized controlled 
trial is warranted to demonstrate the safety and feasibility of an ileostomy closure in an overnight 
hospitalization setting to eventually transform this procedure in a day-case surgery.  
 
1.8 Objectives 
The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 
overnight surgery setting, using a multi-center, 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 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, 
complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection 
rate and mortality rate. 
 
1.9 Hypothesis 
We believe 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. 
 
 
2. Methods and Analysis 
2.1 Study Design 
This study is an open-label, randomized controlled trial designed to evaluate the safety and 
feasibility of ileostomy closure performed in a overnight surgery setting after undergoing a 
standardized enhanced recovery pathway specific to ileostomy closure. This multicenter study will 
be opened to other Canadian centers. Adult patients without significant comorbidities (ASA I and 
II) undergoing elective ileostomy closure who consented to participate in the study will be enrolled 
in a standardized enhanced recovery pathway specific to ileostomy closure. Right after surgery is 
done, they will be randomized either to the group 23-hour stay or the group conventional 
hospitalization. Postoperative data will be prospectively collected on a 30-day period after the 
surgery and will include total hospital length of stay, readmissions, postoperative complications, 
more precisely postoperative ileus and surgical site infections, as well as mortality.  
 
2.2 Participants 
 
2.2.1 Population 
Data will be gathered using primary data collection strategies. This is a Canadian multi-center 
open-label randomized controlled trial and each center taking part in this study will be responsible 

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for collecting its own data and will proceed according to a pre-established standardized protocol. 
Surgeons and members of the research team of each center will identify patients scheduled to 
undergo elective ileostomy closure and then determine if they meet the inclusion criteria of the 
study.  
 
2.2.2 Inclusion criteria 
Patients admitted for ileostomy loop closure who meet the following criteria will be eligible to 
participate in the study: 
• 
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 
 
2.2.3 Exclusion criteria 
Patients admitted for ileostomy loop closure who meet the following criteria will be excluded from 
the study: 
• 
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) 
 
 
 
 
 
 
 
 
 
 
 
 

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Preoperative meeting with the surgeon and/or                                          
a membre of the research team : 
- Study is introduced and explained 
- Informed consent is obtained 
- A study ID is attributed to each patient 
- Preoperative questionaire is completed 
- A copy of the Information and consent form is given to each patient 
Preoperative meeting with a stoma care nurse specialist : 
- Stimulation of the efferent limb of the ileostomy is taught 
- A pamphlet describing the procedure is given to each patient 
Stimulation of the efferent limb of the ileostomy 
during the seven days before ileostomy closure 
Ileostomy closure and                  
randomization right after surgery 
Intervention group :               
23-hour stay 
Discharge when criteria listed in 
section 2.5.2 are met 
Favourable evolution 
after discharge 
Telephone follow-ups on 
postoperative days 2 and 5 
Outpatient clinic 
appointment 4 to 6 weeks 
after the surgery 
Readmission 
Control group :                
Conventional hospitalization 
Discharge when criteria listed in 
section 2.5.3 are met 
Favourable evolution 
after discharge 
Telephone follow-ups on 
postoperative days 2 and 5                      
(if patient has been discharged) 
Outpatient clinic 
appointment 4 to 6 weeks 
after the surgery 
Readmission 

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2.2.4 Preoperative questionnaire and teaching 
Patients who are planned to undergo ileostomy closure will first meet their colorectal surgeon at 
an outpatient clinic appointment. As surgery is explained and consent for surgery is obtained, the 
surgeon (Dr Alexandre Bouchard, Dr Philippe Bouchard, Dr Sébastien Drolet, Dr Roger C. 
Grégoire, Dr François Letarte or Dr Claude Thibault), a resident in charge of this study (Geneviève 
Morin or Xavier Paré) or the research nurse (Ann Wright) will introduce and explain the study and 
obtain patient’s consent to participate. Each patient will be attributed a study ID and will complete 
a preoperative questionnaire. This questionnaire will contain information on demographics such as 
age, gender, height, and weight. Presence of comorbidities such as diabetes, coronary artery 
disease, cardiac failure, renal failure, chronic obstructive pulmonary disease, and 
immunosuppression as well as previous abdominal surgeries will be assessed. Information 
regarding the initial surgery that led to the creation of the loop ileostomy will also be retrieved 
through the patient's medical file including date of surgery, initial pathology (neoplasia, 
inflammatory bowel disease, diverticular disease, colonic volvulus, trauma or other), type of 
surgery (anterior resection, low anterior resection, sigmoidectomy, right hemicolectomy, total 
colectomy, loop ileostomy alone, ileoanal reservoir or other), type of anastomosis performed 
(stapled or sutured), surgical approach chosen (open or laparoscopic), duration of the surgery in 
minutes, and use or not of pelvic radiotherapy and chemotherapy. A copy of the Information and 
consent form will be given to each participant during this meeting.  
A stoma care nurse specialist will meet all patients at least seven days before their ileostomy closure 
to teach them how to perform the efferent limb stimulation. A pamphlet describing the procedure 
will also be given to them. 
 
2.2.5 Perioperative information 
Further information will be recorded at the time of the ileostomy closure. Patients will be met 
before the surgery in regards to stimulation of the efferent limb of the ileostomy to assess how 
many times it was completed during the seven days before surgery. Problems encountered and 
reasons for non-compliance will also be noted. Preoperative stimulation of the ileostomy has no 
impact on the surgical procedure or on randomization. Information regarding the ileostomy closure 
will be retrieved from the patient medical file in the operative note and surgical protocol. It will 
include date of surgery, interval between the initial surgery and ileostomy closure, duration of the 
surgery in minutes, presence or not of significant adhesions during surgery (based on the surgeon's 
opinion), need for conversion to a midline laparotomy, type of anastomosis performed (stapled or 
sutured), complications during the ileostomy closure (bleeding, serotomy, enterotomy, trauma to 
another organ), estimated blood loss in milliliters, type of skin closure (purse-string or linear), and 
infiltration or not of skin incision with a local anesthetic. If a surgeon decided to exclude the patient 
from the study due to technical factors, the reasons for this decision will be noted. 
 
2.2.6 Postoperative information 
Postoperative information will be assessed during telephone follow-ups and outpatient clinic 
appointment four to six weeks after the surgery using a standardized questionnaire and reviewing 
the patient's medical file. Data collected will include length of initial hospital stay in days, 
readmissions during the 30-day postoperative period, reasons for readmissions, treatment received 
during readmissions, length of hospital stay during readmissions in days, occurrence of 
complications during the 30-day postoperative period including ileus and surgical site infections, 
and mortality. Postoperative complications will be classified using the Clavien-Dindo 
classification. Hence, grade I and II complications will be considered minor and grade III and IV 

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complications will be considered severe. Grade V complications imply death of the patient so they 
will be recorded as mortality instead of complications.   
 
2.3 Randomization 
Patients included in this study will be randomized in the operating room once the surgery is 
completed. Patients will be randomized by a closed envelope method either to the group 23-hour 
stay or the group conventional hospitalisation. Randomization will be performed in a 1:1 equal 
allocation ratio and the sequence will be computer generated. The opaque, sealed, and sequentially 
numbered randomization envelopes will be mixed and distributed to participating centers according 
to each hospital’s expected participation based on their number of ileostomy reversals performed 
per year. To randomize a patient, the surgeon will open the next consecutively numbered envelope. 
 
2.4 Blinding 
Due to the study design, it will be impossible to blind the patients to the intervention as it consists 
of either discharge the day after surgery or prolonged hospitalization. However, since 
randomization will occur once the surgery is completed, it ensures all patients to undergo a similar 
surgical procedure irrespective of their treatment arm. 
 
2.5 Trial intervention 
Difference between the intervention group and the control group will lie in whether the patient is 
hospitalized overnight (discharged on the day after surgery) (intervention group) or is hospitalized 
as per the current conventional care after ileostomy closure (control group). 
 
2.5.1 Standardized enhanced recovery pathway specific to ileostomy closure 
Patients awaiting an ileostomy closure who fit the inclusion criteria and consent to take part in 
the study will be submitted to a standardized enhanced recovery pathway specific to ileostomy 
closure including antimicrobial and thromboembolic prophylaxis at induction, controlled 
intraoperatively administration of volume, infiltration of all skin incisions with ten millilitres of a 
solution of bupivacaine 0.5% at the end of the procedure, a multimodal pain and nausea 
management favouring oral medication as well as early ambulation and early enteral feeding. 
Moreover, the surgeon will perform a stapled anastomosis and a purse-string closure of the 
wound. Preoperative efferent limb stimulation with an enteral nutritional formula once a day for 
seven days is a measure added to the enhanced recovery pathway for this study to reduce the 
incidence of ileus and diarrhea secondary to diversion colitis in the postoperative period. It will 
consist of inserting a Foley catheter in the efferent limb of the ileostomy over about ten cm and 
insufflating the balloon of the catheter making sure it is below the fascia. Then, 220 milliliters of 
an enteral nutritional formula will be injected slowly using a syringe. All participants will meet a 
stoma care nurse specialist at least seven days before their surgery to receive teaching on how to 
perform the stimulation of the efferent limb of their ileostomy. During the teaching session, a 
pamphlet describing the procedure will be provided to the patients and the stoma care nurse 
specialist will make sure the patients understand the different steps and are able to perform this 
intervention themselves.  
 
 
 
 
 
2.5.2 Intervention group 

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Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if 
they meet the following discharge criteria : 
• 
Hemodynamically stable 
• 
Temperature < 38.3 Celsius 
• 
Alert and oriented 
• 
Pain score < 5 (on a scale from 0 to 10) 
• 
Tolerating oral diet without nausea or vomiting 
• 
Passed urine 
• 
Able to mobilize 
If all the criteria are not met on the morning of the day following their surgery, patients will stay 
hospitalized until they are met. Moreover, even if all the discharge criteria are met, the operating 
surgeon will always be allowed to keep a patient hospitalized if he deems it necessary and 
beneficial to the patient.  
Patients will be contacted by telephone on postoperative days two and five to ensure that they 
evolve favourably. Patients will be instructed to contact the on-call surgical resident assigned to 
this study at any time if they have concerns. These interventions will be under the supervision of 
the on-call surgeon and they will be documented by evolutive notes. Finally, an outpatient clinic 
appointment will be scheduled four to six weeks following the surgery. 
 
2.5.3 Control group 
Patients randomized to the group conventional hospitalization will be hospitalized as per the 
current conventional care after ileostomy closure. Thus, they will be discharged once they meet the 
criteria listed in section 2.5.2 as well as a return of bowel function. The admitting surgeon will also 
need to feel comfortable discharging them. If they leave before postoperative day five, these 
patients will also be contacted by telephone on postoperative days two and five to ensure that they 
evolve favourably. An outpatient clinic appointment will also be scheduled four to six weeks 
following the surgery. 
 
2.6 Outcomes 
The primary outcome will be total length of hospital stay and will include 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. Secondary 
outcomes, at 30 days following the ileostomy closure, will include readmission rate, postoperative 
complication rate, minor and severe, postoperative ileus rate, postoperative surgical site infection, 
and mortality rate. Readmission will be defined as any unplanned consultation to an hospital in the 
30-day period after surgery. Postoperative complications will include ileus, surgical site infection, 
bowel obstruction, anastomotic leak, pneumonia, myocardial infarction, acute kidney injury, 
urinary tract infection, delirium, and pseudomembranous colitis. Ileus will be defined as inability 
to tolerate oral intake due to nausea and/or vomiting or the need to insert a nasogastric tube by 
postoperative day 3 in the absence of mechanical obstruction or another indication for a nasogastric 
tube such as intubation.  
 
2.7 Sample size 
To estimate the mean total length of stay following elective ileostomy closure, the retrospective 
analysis conducted by Dr François Letarte at St. Paul’s Hospital mentioned in section 1.2 was used 
as well previous reported outcomes of length of hospital available in the literature mentioned in 
section Background and rationale. Using these same data sources, we estimated a readmission rate 
of about 15% with a mean length of stay during readmission of five days. Considering these results, 

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we estimated the mean total length of stay following elective ileostomy closure to be 6.5 days with 
a standard deviation of 8.7 days. Sample size was calculated to detect a four-day decrease in mean 
total length of hospital stay for the intervention group with a power of 90% and a type I error of 
0.05 for a multicentric study with an intraclass correlation of 0.20. Based on these specifications, 
a sample of 80 individuals per treatment arm and a total of 160 subjects will be necessary. 
Assuming an expected withdrawal rate of less than 5% during the trial, a total sample size of 168 
(n = 2 x 84) subjects will be required. 
 
2.8 Statistical analysis 
Data analysis will be performed by the blinded statistician assigned to this study. Baseline 
characteristics of both groups will be reported. Descriptive statistics will be reported including 
mean, median, standard deviations, and ranges. We will use Student’s t test, the Mann–Whitney U 
test, or analysis of variance (ANOVA) for comparing means, when appropriate. Categorical 
variables will be compared with the χ2 test. Odds ratios with associated 95% confidence intervals 
(CI) will be calculated with logistic models for binary data (readmissions, complications). 
Multivariate models will include variables statistically associated with those in univariate analysis, 
as well as those considered to have clinical relevance in the primary outcome (total length of 
hospital stay). All statistics will be two-tailed and a p value < 0.05 will be deemed significant. 
Statistical analysis will be done with SAS Statistical Software v.9.4 (SAS Institute, Cary, NC, USA) 
for all outcomes measures using an intention to treat analysis even in the cases of crossover or non-
compliance to the study protocol. For example, patients randomized to discharge at 23 hours who 
end up being hospitalized will still be analyzed in the intervention group. 
 
2.9 Study limitations 
A first limitation of this study results from the potential lack of compliance to the enhanced 
recovery pathway by the patients since the efferent limb stimulation implies significant care 
provided by the patient on its own. However, this will increase the external validity of the study as 
it will measure the effectiveness of the pathway rather than its efficacy. Also, since the 
randomization will occur after the surgery, compliance to preoperative protocol and surgical 
technique should be similar between both groups.  
A second limitation will be regarding external validity. The results of this study will not be 
applicable to every patient undergoing ileostomy closure as the inclusion and exclusion criteria and 
the implications of the enhanced recovery pathway will prevent a small proportion of patients to 
enter the study. However, based on analysis of the cohort of patients at St. Paul’s Hospital 
mentioned in section 1.2, the inclusion and exclusion criteria used in this study will encompass 
around 90% of the population of patients undergoing ileostomy closure. 
Finally, readmissions will be underestimated in the control group since they will most likely stay 
hospitalized longer initially.  
 
2.10 Study implications 
This clinical trial will be at the forefront of emerging changes in the way patients are treated in the 
perioperative period for this common procedure where not much change has occurred in the past 
two decades. This study would be the first looking at the association of a 23-hour stay with 
preoperative efferent limb stimulation. The approach proposed by this trial have the potential to be 
adopted by other institutions around the world leading to a generalized transformation of a 
procedure where patients used to stay hospitalized for multiple days to a procedure where patients 
would go home on the following morning. This would clearly be beneficial to the patients as well 
as to health institutions. 

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