Fortune of Temporary Ileostomies in Patients After Rectal Cancer Surgery

NCT02532478 | Completed

• 1 other identifier: DrLutfi
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Loop Ileostomy

Outcome Measures

Primary Outcomes (1)

• Stoma closure rate

  up to 84 months

Other Outcomes (2)

• Postoperative complications after primary surgery

  30 days

• 5-year overall survival

  5 years

Study Arms (2)

Stoma reversed

Patients whose ileostomy have been closed after laparoscopic low anterior resection

Stoma not-reversed

Patients whose ileostomy have not been closed due to some problems

Eligibility Criteria

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

Study Population

patients who underwent laparoscopic low anterior resection for rectal cancer with a diverting ileostomy between 2007 and 2014.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 25, 2015
• Study Start: February 1, 2007
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 25, 2015

Record last verified: 2015-08