The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-09-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

No blinding or masking is implemented in this open-label study. Both participants and healthcare providers are aware of the intervention status. This design allows for transparency in the treatment approach, and outcomes will be assessed without blinding. The lack of masking is a characteristic of the study design and does not impact the validity of the results.

Study Groups

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Non-Ileostomy Arm

Participants in this arm do not undergo the intervention of a protective ileostomy. The management for this group involves. The outcomes for this arm will be assessed in comparison to the group that receives the protective ileostomy. This arm serves as the control/comparative group to evaluate the impact of the intervention on the specified outcomes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ileostomy Arm

Ileostomy Arm Description: Participants in this arm undergo the intervention of a protective ileostomy. The surgical procedure involves. This arm serves as the experimental group to evaluate the impact of the protective ileostomy on specified outcomes. The outcomes for this arm will be compared to those in the non-interventional (comparative) arm to assess the effectiveness and potential benefits of the ileostomy intervention.

Group Type EXPERIMENTAL

protective ileostomy

Intervention Type PROCEDURE

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.

Interventions

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protective ileostomy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).