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CompletedNCT05635188Updated Dec 5, 2022

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

An observational study in Colostomy Stoma, Colostomy Complication and Obstruction Bowel, sponsored by Instituto do Cancer do Estado de São Paulo. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Instituto do Cancer do Estado de São Paulo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
154
Sex
All
01

Study 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).

02

Conditions studied

  • Colostomy Stoma
  • Colostomy Complication
  • Obstruction Bowel
  • Surgical Complication
  • Surgical Procedure, Unspecified

Keywords

  • colostomy
  • laparoscopy
  • ostomy
03

In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's enrollment of 154 is close to the median of 152 across 68 observational studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

Instituto do Cancer do Estado de São Paulo is the lead sponsor of 90 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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)

Inclusion criteria

  • Patients who underwent emergency colostomy or ileostomy

Exclusion criteria

Exclusion Criteria:

  • Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
154 participants (actual)
Patient registry
No

Groups and cohorts

  • Open Surgery

    Procedure: Intestinal ostomy confection

  • Laparoscopic Surgery

    Procedure: Intestinal ostomy confection

  • Trephine Surgery

    Procedure: Intestinal ostomy confection

Interventions

  • ProcedureIntestinal ostomy confection

    Surgical procedure for fecal diverting

06

What researchers measure

Primary outcomes

  1. Surgical complications

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

    Time frame: Between cohort enter (2008-2019) and study finish (2021)

Secondary outcomes

  1. Postoperative length of hospital stay

    Length of hospital stay after surgery

    Time frame: Between cohort enter (2008-2019) and study finish (2021)

07

Study locations

1 site
  • Instituto do Câncer do Estado de São Paulo - ICESP
    São Paulo, SP 01246-000, Brazil
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References and documents

Individual participant data

Plan to share: No — We intend to publish the results of the study, but not make available individual participant date

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05635188
Lead sponsor
Instituto do Cancer do Estado de São Paulo
Responsible party
Gabriella Rosceli Campos Zerbetto (Principal Investigator, Instituto do Cancer do Estado de São Paulo) — Principal investigator
First posted
Dec 2, 2022
Start date
Jan 2008
Primary completion
Dec 2019
Completion
Dec 2021
Last update
Dec 5, 2022

Study contacts

Gabriella Rosceli C Zerbetto
principal investigator · Instituto do Cancer do Estado de São Paulo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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