Impact of Surgical Technique on Post-operative Complicati... | NCT05635188

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2021Actual

First Submitted Date

Nov 22, 2022

First Submission Date that Met QC Criteria

Nov 22, 2022

First Posted Date

Dec 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2022

Last Update Posted Date

Dec 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriella Rosceli Campos Zerbetto, Principal Investigator, Instituto do Cancer do Estado de São PauloPrincipal Investigator

Lead Sponsor

Instituto do Cancer do Estado de São PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open Surgery			Procedure: Intestinal ostomy confection
Laparoscopic Surgery			Procedure: Intestinal ostomy confection
Trephine Surgery			Procedure: Intestinal ostomy confection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intestinal ostomy confection	Procedure	Surgical procedure for fecal diverting	Laparoscopic Surgery Open Surgery Trephine Surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriella Rosceli C Zerbetto	Instituto do Cancer do Estado de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Câncer do Estado de São Paulo - ICESP		São Paulo	São Paulo	01246-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases