Laparoscopic Surgery of Rectal Cancer and Ileostomy

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Completed

CT.gov ID

NCT04169425

Collaborator

(none)

150

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy - Stoma Ileostomy; Complications Leakage, Anastomotic	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 Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 2, 2012

Actual Primary Completion Date :

Dec 22, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Number of participants with post-operative complications [90 days]
post-operative complication 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 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 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
Number of participants with anastomotic stenosis [90 days]
post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection

Eligibility Criteria

Criteria

Ages Eligible for Study:

67 Years to 86 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Campus Bio-Medico University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vincenzo La Vaccara, Principal Investigator, Campus Bio-Medico University

ClinicalTrials.gov Identifier:

NCT04169425

Other Study ID Numbers:

11.17 OSS Comet CBM

First Posted:

Nov 19, 2019

Last Update Posted:

Nov 21, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anastomotic Leak

Study Results

No Results Posted as of Nov 21, 2019