NCT00888888

Brief Summary

Although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy into a major colonic resection. The investigators aimed to identify the risk factors that lead the surgeon to perform a colonic resection in patients undergoing surgery for initially suspected acute appendicitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

April 27, 2009

Last Update Submit

October 29, 2012

Conditions

Keywords

Acute appendicitisColonic diverticulitisColonic tumorsColonic resections

Outcome Measures

Primary Outcomes (1)

  • Short-term survival

    3 months

Secondary Outcomes (1)

  • Long-term survival

    5 years

Study Arms (1)

Cohort: Patients with colonic resections

Colonic resections in patients submitted to appendicectomy for suspected acute appendicitis

Procedure: Right hemicolectomy with or without primary anastomosis

Interventions

During open classic appendectomy (McBurney incision) the surgeon decided to convert to midline extended laparotomy to perform a right hemicolectomy

Cohort: Patients with colonic resections

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients submitted to appendectomy for suspected acute appendicitis and in whom the surgeon takes the decision to convert to right colectomy based on operative findings and other factors the we aim to identify

You may qualify if:

  • Patients older than 15 years of age
  • Male or female
  • Suspected of having acute appendicitis
  • Converted to right hemicolectomy

You may not qualify if:

  • Patients in whom a right hemicolectomy was planned initially
  • Right hemicolectomy for causes other than suspected acute appendicitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de La Serena

La Serena, Coquimbo Region, IV REGION, Chile

Location

MeSH Terms

Conditions

AppendicitisDiverticulitis, Colonic

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesDiverticulitisDiverticular DiseasesDiverticulosis, ColonicColonic Diseases

Study Officials

  • MARCELO A BELTRAN, M.D.

    Hospital de La Serena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DIGESTIVE SURGEON

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations