An observational study in Ileostomy - Stoma, Ileostomy; Complications and Leakage, Anastomotic, sponsored by Campus Bio-Medico University. Completed. Open to participants aged 67 Years to 86 Years. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Campus Bio-Medico University · Observational
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.
From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.
209 studies on the registry are indexed under Anastomotic Leak; 60 are open to participants now.
This study's enrollment of 150 is below the median of 200 across 108 observational studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent to laparoscopic TME, for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma.
Exclusion Criteria:
patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer
Procedure: elective diverting ileostomy
patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer
Number of participants with anastomotic leakage
Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema
Time frame: 90 days
Number of participants with post-operative complications
post-operative complication in patients submitted to Anterior Rectal Resection
Time frame: 90 days
Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever
post-operative fever in patients submitted to Anterior Rectal Resection
Time frame: 90 days
Number of participants with surgical site infection
post-operative surgical site infection in patients submitted to Anterior Rectal Resection
Time frame: 90 days
Number of participants with abdominal collections
post-operative abdominal collections in patients submitted to Anterior Rectal Resection
Time frame: 90 days
Number of participants with anastomotic bleeding
post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection
Time frame: 90 days
Number of participants with perforation
post-operative perforation in patients submitted to Anterior Rectal Resection
Time frame: 90 days
Number of participants with anastomotic stenosis
post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection
Time frame: 90 days
No study locations are listed for this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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