Laparoscopic Surgery of Rectal Cancer and Ileostomy

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

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy; Complications; Ileostomy - Stoma; Leakage, Anastomotic
• Intervention / Treatment: Procedure: elective diverting ileostomy

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 Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 67 years to 86 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent to laparoscopic TME, for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer	Procedure: elective diverting ileostomy
Group 2; patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start: January 2, 2012
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 17, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: 11.17 OSS Comet CBM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No