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

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT05635188
Collaborator
(none)
154
1
167
0.9

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intestinal ostomy confection

Study Design

Study Type:
Observational
Actual Enrollment :
154 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Impact of Surgical Technique (Laparoscopic, Open or Trephine) on Post-operative Complications in Urgency Ostomy Confection - a Single Center Retrospective Cohort
Actual Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Surgical complications [Between cohort enter (2008-2019) and study finish (2021)]

    Early and late surgical complications related to the stoma and severe complications

Secondary Outcome Measures

  1. Postoperative length of hospital stay [Between cohort enter (2008-2019) and study finish (2021)]

    Length of hospital stay after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto do Câncer do Estado de São Paulo - ICESP São Paulo SP Brazil 01246-000

Sponsors and Collaborators

  • Instituto do Cancer do Estado de São Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gabriella Rosceli Campos Zerbetto, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT05635188
Other Study ID Numbers:
  • 4.834.729
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gabriella Rosceli Campos Zerbetto, Principal Investigator, Instituto do Cancer do Estado de São Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022