NCT04169425

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

6 years

First QC Date

November 17, 2019

Last Update Submit

November 19, 2019

Conditions

Ileostomy - StomaIleostomy; ComplicationsLeakage, Anastomotic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of participants with post-operative complications

    90 days

  • Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever

    90 days

  • Number of participants with surgical site infection

    90 days

  • Number of participants with abdominal collections

    90 days

  • Number of participants with anastomotic bleeding

    90 days

  • +2 more secondary outcomes

Study Arms (2)

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

Interventions

elective diverting ileostomyPROCEDURE
Group 1

Eligibility Criteria

Age67 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • adult patients (aged 18 years and over)
  • patients submitted to elective Anterior Rectal Resection

You may not qualify if:

  • chronic use of immunosuppressant agents
  • urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2019

First Posted

November 19, 2019

Study Start

January 2, 2012

Primary Completion

December 22, 2017

Study Completion

February 1, 2018

Last Updated

November 21, 2019

Record last verified: 2019-11