Laparoscopic Surgery of Rectal Cancer and Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169425
• Other study ID #: 11.17 OSS Comet CBM
• Status: Completed
• Start date: January 2, 2012
• Est. completion date: February 1, 2018

Study information

• Verified date: November 2019
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 1, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 67 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Ileostomy - Stoma
• Ileostomy; Complications
• Leakage, Anastomotic

Intervention

Procedure:
• elective diverting ileostomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with post-operative complications	post-operative complication in patients submitted to Anterior Rectal Resection	90 days
Secondary	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
Secondary	Number of participants with surgical site infection	post-operative surgical site infection in patients submitted to Anterior Rectal Resection	90 days
Secondary	Number of participants with abdominal collections	post-operative abdominal collections in patients submitted to Anterior Rectal Resection	90 days
Secondary	Number of participants with anastomotic bleeding	post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection	90 days
Secondary	Number of participants with perforation	post-operative perforation in patients submitted to Anterior Rectal Resection	90 days
Secondary	Number of participants with anastomotic stenosis	post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection	90 days