The Effect of Breastfeeding on the Development of Appendicitis in Adults

February 16, 2019 updated by: Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
Appendectomy is the most common emergent operative procedure performed worldwide. In this study investigators will investigate if there is a relationship between breast feeding and appendicitis in adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acute appendicitis accounts for the commonest indication for emergency visits during daily surgical practice. Breast feeding is very important both mother and the child. For the infant, breast feeding has an important role on the maturity of immune system. In the literature search, there are a little studies about the relationship between the breast feeding and appendicitis. In the literature, some studies suggests that the breast feeding may possibly give protection against the development of appendicitis. But the number of the patients and the control groups are limited. Because of that the investigators have planned to make this study with a lot of number of patients.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa Yuksek Ihtisas Training and Research Hospital
      • Istanbul, Turkey, 34371
        • Sisli Etfal Training and Research Hospital
      • Istanbul, Turkey
        • Bezmialem Vakif University
      • Istanbul, Turkey
        • Arnavutkoy State Hospital
      • Istanbul, Turkey
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

500 patients who has pathologically proven appendicitis, and 1000 participants without appendicitis.

Description

Inclusion Criteria:

  • Subjects has pathologically proven appendicitis for appendicitis group.

Exclusion Criteria:

  • Subjects has American Society of Anesthesiologists Physical Status classification 4,
  • Subject has pregnancy,
  • Subject has malignity,
  • Subject has chronic illness,
  • Subjects who won't accept to join the study
  • Subjects who don't have family members

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Appendicitis
The patients with appendicitis
Other: Breastfeeding
All of the participants and patients will have a questionnaire about their breastfeeding
Control
The participants without appendicitis
Other: Breastfeeding
All of the participants and patients will have a questionnaire about their breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The breastfeeding status questionnaire in the appendicitis patients and participants without appendicitis
Time Frame: 2 days
500 patients who have pathologically proven appendicitis and 1000 controls without appendicitis will be asked the question which is "How long did you had breast feeding?". The patients and the participants will be in the same age groups. Also the same question will be asked to at least one of the family member (mother, father, older brother or older sister). The breastfeeding status will be in three group ( 0-2 months, 2-6 months and >6 months)
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Collaborators

Bezmialem Vakif University
Istanbul Training and Research Hospital
Bursa Yüksek İhtisas Education and Research Hospital
Arnavutkoy State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREASTFEEDING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Because the time period of this study is very short

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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