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

NCT05635188 | Completed DMC

• 1 other identifier: 4.834.729
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

colostomy; laparoscopy; ostomy

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Postoperative length of hospital stay

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

Study Arms (3)

Open Surgery

Procedure: Intestinal ostomy confection

Laparoscopic Surgery

Procedure: Intestinal ostomy confection

Trephine Surgery

Procedure: Intestinal ostomy confection

Interventions

Intestinal ostomy confection PROCEDURE

Surgical procedure for fecal diverting

Laparoscopic Surgery; Open Surgery; Trephine Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Patients who underwent emergency colostomy or ileostomy

You may not qualify if:

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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gabriella Rosceli C Zerbetto

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: January 1, 2008
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)