Skip to main content
OpenTrials
Completed

NCT Number: NCT02532478

Fortune of Temporary Ileostomies in Patients After Rectal Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Stoma closure rate

    Time frame: up to 84 months

Other outcomes

  1. Postoperative complications after primary surgery

    Time frame: 30 days

    not only 30-day but all in-hospital complications including readmissions

  2. 5-year overall survival

    Time frame: 5 years

    the time from the primary operation {laparoscopic low anterior resection} to death from any cause

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2015
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.