Clinical trial NCT06391385: The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer
Official title: The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer, A Prospective Comparative Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Rectal cancer
ileostomy
morbidity
anterior rectal resection
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The surgical procedure was 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 was performed either with a stapler or by hand-sewn. Patients were assigned to group I (19 patients) who had undergone temporary ileostomy, and group II (28 patients) who didn't undergo ileostomy. Patients were followed up at regular intervals and outcomes were compared between two groups.
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective comparative cohort study was to assess the effect of protective ileostomy on the outcomes of patients with rectal cancer who underwent low anterior rectal (LAR) resection in 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 main question to answer is does protective ileostomy reduce leakage, SSI rate, and duration of hospitalization in patients with colorectal cancer. . Patients are divided into two groups: group 1: patients who underwent ileostomy (19 patients), and group 2 is the comparative group: patients who didn't (28 patients). Morbidity and mortality were compared between the two groups, to study the outcomes of protective ileostomy

Detailed description: Anastomotic leakage is encountered frequently after colorectal cancer (CRC) surgery, which is considered one of the potentially lethal complications, affecting the quality of life and increasing hospital costs. The role of a protective stoma has been debated. Therefore, The purpose of this study was to assess the effect of protective ileostomy on the outcomes of patients with rectal cancer who underwent low anterior rectal (LAR) resection.

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 were patients who underwent abdominoperineal resection with permanent ileostomy. The following workup included: a history and physical examination.

Preparation of the bowel was performed before surgery with the administration of intravenous perioperative antibiotic prophylaxis. The surgical procedure was 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 was performed either with a stapler or by hand-sewn. Patients were assigned to group I (19 patients) who had undergone temporary ileostomy, and group II (28 patients) who didn't undergo ileostomy. Patients were followed up at regular intervals and outcomes were compared between two groups.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of colorectal cancer that required low anterior resection(LAR)
* Both sexes
* All ages
* Attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023).

Exclusion Criteria:

* Patients who underwent abdominoperineal resection with permanent ileostomy.

Primary outcomes:
measure: The Rate of Anastomosis leakage
timeFrame: up to 2 weeks post operatively
measure: The Rate of Surgical Site Infection
timeFrame: up to 6 weeks post operatively
Secondary outcomes:
Other outcomes:
measure: The Duration of surgery
timeFrame: from open incision to skin until closing the skin during the operaton
measure: The Duration of Hospitalization
timeFrame: from day 0 post surgery until discharge from the hospital , up to 4 weeks
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
References: