Fortune of Temporary Ileostomies in Patients After Rectal Cancer Surgery

Loop Ileostomy Clinical Trial

Official title:

Fortune of Temporary Ileostomies in Patients Treated With Laparoscopic Low Anterior Resection for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532478
• Other study ID #: DrLutfi
• Status: Completed
• Phase: N/A
• First received: August 19, 2015
• Last updated: August 21, 2015
• Start date: February 2007
• Est. completion date: February 2014

Study information

• Verified date: August 2015
• Source: Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The risk factors for stoma reversal failure have been rarely studied, which is probably one of the worst scenarios for a case who has a sphincter preserving procedure for a rectal cancer and is expecting to have regular bowel movements through a functional anus. Several studies have analyzed this particular issue and some have shown that up to 30% of 'temporary' stomas have never been closed. However these data have been criticized to be heterogeneous, since they have included patients with benign and malignant diseases, cases underwent elective or emergent anterior or low anterior resections or restorative proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some studies have underlined some risk factors for the failure of stoma reversal, but they also have similar limitations as mentioned above. Finally, survival -to the best of investigators' knowledge- has never been separately studied in patients who cannot receive a stoma reversal procedure. Thus, current study aims to present a single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to expose the fortune of these cases.

Description:

Defunctioning stomas are commonly formed in order to divert the bowel stream mostly in case of distal anastomosis, particularly after a low anterior resection. It has been reported that a temporary ileostomy may decrease the risk of an anastomotic leak, which is a lethal complication. In addition, in case of an anastomotic leak, stomas may limit the septic sequence and may help the diseased anastomosis to heal or the area of inflammation to resolve. Stomas have been also shown to decrease the necessity of an urgent reoperation due to septic intra-abdominal complications that may occur after an anastomotic leak. Many believe that stoma complications are generally easily managed and reversal of stomas are associated with limited morbidity. Thus, selective or routine creation of diverting stomas have been recommended in patients underwent a low anterior resection.

The risk factors for stoma reversal failure have been rarely studied, which is probably one of the worst scenarios for a case who has a sphincter preserving procedure for a rectal cancer and is expecting to have regular bowel movements through a functional anus. Several studies have analyzed this particular issue and some have shown that up to 30% of 'temporary' stomas have never been closed. However these data have been criticized to be heterogeneous, since they have included patients with benign and malignant diseases, cases underwent elective or emergent anterior or low anterior resections or restorative proctocolectomy; and those with a colostomy or ileostomy, even an end stoma in some subjects. In addition, some studies have underlined some risk factors for the failure of stoma reversal, but they also have similar limitations as mentioned above. Finally, survival -to the best of investigators' knowledge- has never been separately studied in patients who cannot receive a stoma reversal procedure. Thus, current study aims to present a single-surgeon experience regarding the rate of diverting ileostomy takedown, the factors adversely affecting stoma reversal rate in patients underwent laparoscopic low anterior resection for rectal cancer, and accordingly to expose the fortune of these cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who received laparoscopic low anterior resection and loop ileostomy for rectal cancer, except:

Exclusion Criteria:

• patients undergoing an operation for a benign or recurrent disease or an emergent condition,

• those presenting with insitu cancer or dysplasia without an invasive cancer,

• those with cancers other than adenocarcinomas,

• those received a restorative proctocolectomy,

• those necessitated diversion for an irresectable tumor,

• those received a diverting/end colostomy or end ileostomy,

• Patients who had a recurrent disease and/or unresectable metastasis after the creation of stoma

• those received a temporary stoma during the last 12 months

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Loop Ileostomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications after primary surgery	not only 30-day but all in-hospital complications including readmissions	30 days	No
Other	5-year overall survival	the time from the primary operation {laparoscopic low anterior resection} to death from any cause	5 years	No
Primary	Stoma closure rate		up to 84 months	No