The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer, A Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- The Rate of Anastomosis leakage
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of colorectal cancer that required low anterior resection(LAR)
- •Both sexes
- •Attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023).
排除标准
- •Patients who underwent abdominoperineal resection with permanent ileostomy.
结局指标
主要结局
The Rate of Anastomosis leakage
时间窗: up to 2 weeks post operatively
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
The Rate of Surgical Site Infection
时间窗: up to 6 weeks post operatively
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.
次要结局
未报告次要终点