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NCT05635188 Clinical Trial

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

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05635188
Other study ID # 4.834.729
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2008
Est. completion date December 2021

Study information
Verified date December 2022
Source Instituto do Cancer do Estado de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date December 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intestinal ostomy confection
Surgical procedure for fecal diverting

Locations
Country Name City State
Brazil Instituto do Câncer do Estado de São Paulo - ICESP São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical complications Early and late surgical complications related to the stoma and severe complications Between cohort enter (2008-2019) and study finish (2021)
Secondary Postoperative length of hospital stay Length of hospital stay after surgery Between cohort enter (2008-2019) and study finish (2021)
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