Laparoscopic Surgery of Rectal Cancer and Ileostomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.

Conditions
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Ileostomy - Stoma, Ileostomy; Complications, Leakage, Anastomotic

Intervention / Treatment
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* Procedure: elective diverting ileostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (aged 18 years and over) patients submitted to elective Anterior Rectal Resection Exclusion Criteria: chronic use of immunosuppressant agents urgent surgery

Ages Eligible for Study
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Minimum Age: 67 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer | Procedure: elective diverting ileostomy<br> <br> |
| Group 2<br>patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with post-operative complications | post-operative complication in patients submitted to Anterior Rectal Resection | 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 | 90 days | 
| Number of participants with surgical site infection | post-operative surgical site infection in patients submitted to Anterior Rectal Resection | 90 days | 
| Number of participants with abdominal collections | post-operative abdominal collections in patients submitted to Anterior Rectal Resection | 90 days | 
| Number of participants with anastomotic bleeding | post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection | 90 days | 
| Number of participants with perforation | post-operative perforation in patients submitted to Anterior Rectal Resection | 90 days | 
| Number of participants with anastomotic stenosis | post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection | 90 days |