Laparoscopic Surgery of Rectal Cancer and Ileostomy

NCT ID: NCT04169425

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-02

Study Completion Date

2018-02-01

Brief Summary

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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

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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.

Conditions

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Ileostomy - Stoma Ileostomy; Complications Leakage, Anastomotic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer

elective diverting ileostomy

Intervention Type PROCEDURE

Group 2

patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer

No interventions assigned to this group

Interventions

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elective diverting ileostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

67 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo La Vaccara

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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11.17 OSS Comet CBM

Identifier Type: -

Identifier Source: org_study_id

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