Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391385
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-01-04
Brief Title:
The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer
Sponsor:
Tishreen University
Organization:
Tishreen University
Study Overview
Official Title:
The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer A Prospective Comparative Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ileostomy
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 resectionLAR 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 didnt 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 resectionLAR 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 didnt undergo ileostomy Patients were followed up at regular intervals and outcomes were compared between two groups
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 resectionLAR 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 didnt undergo ileostomy Patients were followed up at regular intervals and outcomes were compared between two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None