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

Colorectal Cancer Clinical Trial

— Ileostomy  

Official title:

The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer, A Prospective Comparative Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06391385
• Other study ID #: Tishreen_ Temporary Ileostomy
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2024
• Source: Tishreen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Duration of surgery	The Duration of Surgery is a critical parameter measured from the initiation of the surgical incision to the closure of the incision. This outcome is pivotal in understanding the efficiency and complexity of the surgical procedure. It encompasses the time required for key stages, such as tumor resection, anastomosis, and closure. A shorter duration may indicate a more streamlined and less invasive procedure, potentially contributing to reduced patient morbidity and improved postoperative outcomes. Monitoring the Duration of Surgery as a primary outcome provides valuable insights into the procedural intricacies and overall efficiency of the interventions, aiding in the evaluation of the protective ileostomy's impact on surgical timelines.	from open incision to skin until closing the skin during the operaton
Other	The Duration of Hospitalization	The Duration of Hospitalization refers to the total time a patient spends in the hospital after undergoing low anterior rectal (LAR) resection with or without protective ileostomy. This outcome is crucial in assessing the postoperative recovery period and resource utilization. A shorter duration may indicate a smoother recovery and reduced postoperative complications, potentially contributing to decreased healthcare costs. Monitoring the Duration of Hospitalization as a primary outcome provides essential information about the impact of protective ileostomy on the length of hospital stay, aiding in the evaluation of its influence on patient recovery and healthcare resource management.	from day 0 post surgery until discharge from the hospital , up to 4 weeks
Primary	The Rate of Anastomosis leakage	Anastomosis leakage is defined as the unintended escape of gastrointestinal contents from the site of surgical anastomosis, typically occurring after a low anterior rectal (LAR) resection. It is a critical postoperative complication that can lead to various adverse effects, including peritonitis, abscess formation, and increased morbidity. The evaluation of anastomosis leakage involves careful monitoring for clinical signs, diagnostic imaging, and, if necessary, interventions such as reoperation or drainage procedures. The occurrence and management of anastomosis leakage serve as a key primary outcome measure in this study, contributing valuable insights into the efficacy and safety of the protective ileostomy intervention	up to 2 weeks post operatively
Primary	The Rate of Surgical Site Infection	Surgical Site Infection is a postoperative complication characterized by the invasion of microorganisms into the surgical incision or the deeper tissues surrounding the operative site. In the context of this study, the evaluation of SSI involves monitoring for clinical signs of infection, such as redness, swelling, warmth, or discharge, and may require additional diagnostic assessments. The occurrence of Surgical Site Infection is a critical parameter, impacting patient recovery, healthcare costs, and overall postoperative morbidity. As a primary outcome measure, the study aims to comprehensively assess the incidence and characteristics of SSI, providing crucial insights into the effectiveness of the protective ileostomy intervention.	up to 6 weeks post operatively