Laparoscopic Surgery of Rectal Cancer and Ileostomy

Completed

• Conditions: Ileostomy - Stoma; Ileostomy; Complications; Leakage, Anastomotic
• Interventions: Procedure: elective diverting ileostomy

• Registration Number: NCT04169425
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01-02
• Primary Completion: 2017-12-22
• Study Completion: 2018-02-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-17
• Study First Posted: 2019-11-19
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	elective diverting ileostomy	patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer

Primary Outcome Measures

Name	Time	Method
Number of participants with anastomotic leakage	90 days	Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema

Secondary Outcome Measures

Name	Time	Method
Number of participants with anastomotic stenosis	90 days	post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection
Number of participants with post-operative complications	90 days	post-operative complication in patients submitted to Anterior Rectal Resection
Number of participants with surgical site infection	90 days	post-operative surgical site infection in patients submitted to Anterior Rectal Resection
Number of participants with abdominal collections	90 days	post-operative abdominal collections in patients submitted to Anterior Rectal Resection
Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever	90 days	post-operative fever in patients submitted to Anterior Rectal Resection
Number of participants with anastomotic bleeding	90 days	post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection
Number of participants with perforation	90 days	post-operative perforation in patients submitted to Anterior Rectal Resection