Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection

December 1, 2022 updated by: Gabriella Rosceli Campos Zerbetto, Instituto do Cancer do Estado de São Paulo

Impact of Surgical Technique (Laparoscopic, Open or Trephine) on Post-operative Complications in Urgency Ostomy Confection - a Single Center Retrospective Cohort

This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent emergency surgery between 2008 and 2019 by the surgical team of the Cancer Institute of São Paulo State (Instituto do Câncer do Estado de São Paulo - ICESP)

Description

Inclusion Criteria:

  • Patients who underwent emergency colostomy or ileostomy

Exclusion Criteria:

  • Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Surgery
Procedure: Intestinal ostomy confection
Surgical procedure for fecal diverting
Laparoscopic Surgery
Procedure: Intestinal ostomy confection
Surgical procedure for fecal diverting
Trephine Surgery
Procedure: Intestinal ostomy confection
Surgical procedure for fecal diverting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications
Time Frame: Between cohort enter (2008-2019) and study finish (2021)
Early and late surgical complications related to the stoma and severe complications
Between cohort enter (2008-2019) and study finish (2021)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative length of hospital stay
Time Frame: Between cohort enter (2008-2019) and study finish (2021)
Length of hospital stay after surgery
Between cohort enter (2008-2019) and study finish (2021)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Gabriella Rosceli C Zerbetto, Instituto do Cancer do Estado de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.834.729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We intend to publish the results of the study, but not make available individual participant date

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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