The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer, A Prospective Comparative Cohort Study
Phase: NA
Conditions: Colorectal Cancer
Sponsor: Tishreen University

 
 
 
The Effects of temporary ileostomy on outcome in 
patients with rectal cancer, A prospective 
Comparative Cohort Study protocol 
 
 
NCT number: not available yet 
 
Date: 10/9/2021
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
Background  
Colorectal cancer(CRC) represents the most common type of gastrointestinal cancer 
[1]. It is the third most commonly diagnosed cancer in males and the second in females 
according to the World Health Organization (WHO), with various rates of incidence 
around the world [2]. CRC is a multifactorial disease process that includes genetic 
factors, environmental exposures, and inflammatory diseases [3]. There is an 
improvement in outcome and death rates have declined progressively which can be 
attributed to early detection and removal of CRCs in earlier stages and effective 
adjuvant therapy [4]. Surgery is considered currently the definitive treatment modality 
for rectal cancer, and surgical intervention is performed either by local or radical 
excision depending on the clinical stage, size, and location of the primary tumor [5]. 
There are many techniques to be used including local excision, low anterior 
resection(LAR), abdominoperineal resection, and multi-visceral resection [6]. LAR 
represents a sphincter-sparing resection and is performed in patients who meet all the 
following criteria: invasive rectal cancer, the ability to perform negative distal margin, 
and an adequate anorectal sphincter function before surgery [7]. Numerous 
postoperative complications can significantly lead to morbidities, prolonged 
hospitalization, and even mortality, and management of these complications can be 
beneficial for survival rate and improvement of quality of life [7]  
Anastomotic leakage(AL) represents a frequent complication after LAR in patients with 
rectal cancer and is responsible for significant morbidity and mortality. The incidence 
of AL varies from 3 to 21% with a high rate of mortality despite improvements in 

surgical techniques [8]. In addition, AL is associated with worsened functional 
outcomes, reduced quality of life, and increased financial burden. Risk factors for AL 
include more distal anastomoses, neoadjuvant pelvic radiation therapy, male gender, 
prolonged operative time, advanced stage of tumor, and multiple firings of linear stapler 
across rectal stump [9]. The role of a protective stoma has been debated. Therefore, the 
aims of our study were: 1- to evaluate the effect of temporary ileostomy on the 
occurrence of AL, 2-to compare complications between patients according to the 
presence of protective ileostomy.  
 
Methodology 
Patients  
   This is a prospective comparative study of a group of patients with a diagnosis of 
colorectal cancer of both sexes and all ages that required low anterior resection(LAR) 
attending the Department of General Surgery at Tishreen University Hospital in 
Lattakia-Syria during the two years (May 2021- May 2023). The exclusion criteria are 
patients who undergo abdominoperineal resection with permanent ileostomy. The 
following workup included: a history and physical examination.  
Preparation of the bowel is performed before surgery with the administration of 
intravenous perioperative antibiotic prophylaxis. The surgical procedure is  performed 
by laparotomy, with resection of the rectum and mesorectum (TME) up to the level of 
the pelvic diaphragm, sparing the autonomic nerves. End-to-end anastomosis is 
performed either with a stapler or by hand-sewn. Patients are assigned to group I (19 
patients) who will undergo temporary ileostomy, and group II (28 patients) who will 
not undergo ileostomy. Patients are followed up at regular intervals and outcomes were 
compared between two groups. 
 
Data collection 
the following data will be collected through clinical examinations, patient interviews, 
and medical records including : Demographic data including : Age as Continuous 
variable measured in years, Sex as  Categorical variable (Male/Female), Tumor Stage 
as Categorical variable representing the clinical stage of colorectal cancer, 
Radiotherapy as  Binary variable indicating whether the patient received radiotherapy 
before surgery. The Surgical Characteristics are : the Type of Anastomoses as 

Categorical variable (Hand-sewn/Stapled), and Protective Ileostomy as Binary variable 
indicating the presence or absence of a temporary ileostomy. The Outcomes which will 
be measured are : the Duration of Surgery as Continuous variable measured in hours, 
the Anastomosis Leakage as Binary variable indicating the presence or absence of 
leakage, the Surgical Site Infection as Binary variable indicating the presence or 
absence of infection, and the Local Recurrence as  Binary variable indicating the 
presence or absence of local recurrence.  
Patients will be followed for 30 days after surgery to assess short-term outcomes. 
Assessments will be conducted at regular intervals to monitor the occurrence of 
outcomes. 
 
Ethical Considerations 
Written informed consent will be obtained from the patient for publication and any 
accompanying images. A copy of the written consent is available for review on request. 
Ethical approval for this study (Ethical Committee 2021-GS-104) was provided by the 
Ethical Committee  of Tishreen University Hospitals, latakia, Syria on 10 October 2021. 
In addition, the investigators ensure that the study conforms to the principles of the 
Declaration of Helsinki (last revised in 2013) and is conducted in accordance with the 
ICH Guideline for Good Clinical Practice.  
 
Statistical Analysis Plan  
Statistical analysis was performed by using the IBM SPSS version. Basic Descriptive 
statistics included means, standard deviations(SD), median, Frequency, and 
percentages. To examine the relationships and comparisons between the two groups, 
the chi-square test was used. Independent t student tests were used to compare 2 
independent groups. All the tests were considered significant at a 5% type I error 
rate(p<0.05), β:20%, and power of the study:80%. 
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