Loop Ileostomy Clinical Trial
Official title:
Fortune of Temporary Ileostomies in Patients Treated With Laparoscopic Low Anterior Resection for Rectal Cancer
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03720262 -
Prevention of Hernia After Loop Ileostomy Reversal
|
Phase 2/Phase 3 | |
Recruiting |
NCT03411096 -
Quadratus Lumborum Block : Local Anesthesia Versus Placebo
|
N/A |