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

NCT06391385 | Completed DMC

• 1 other identifier: Tishreen_ Temporary Ileostomy
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

Rectal cancer; ileostomy; morbidity; anterior rectal resection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (2)

• The Duration of surgery

  from open incision to skin until closing the skin during the operaton

• The Duration of Hospitalization

  from day 0 post surgery until discharge from the hospital , up to 4 weeks

Study Arms (2)

Non-Ileostomy Arm

NO INTERVENTION

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.

Ileostomy Arm

EXPERIMENTAL

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.

Procedure: protective ileostomy

Interventions

protective ileostomy 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.

Ileostomy Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients who underwent abdominoperineal resection with permanent ileostomy.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

SY (1)