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The Effect of Breastfeeding on the Development of Appendicitis in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679547
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2016
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
Istanbul Training and Research Hospital
Bezmialem Vakif University
Arnavutkoy State Hospital
Bursa Yüksek İhtisas Education and Research Hospital
Information provided by (Responsible Party):
Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Appendicitis Other: Breastfeeding

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
500 patients who has pathologically proven appendicitis, and 1000 participants without appendicitis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679547


Locations
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Turkey
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey
Sisli Etfal Training and Research Hospital
Istanbul, Turkey, 34371
Arnavutkoy State Hospital
Istanbul, Turkey
Bezmialem Vakif University
Istanbul, Turkey
Istanbul Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul Training and Research Hospital
Bezmialem Vakif University
Arnavutkoy State Hospital
Bursa Yüksek İhtisas Education and Research Hospital
Publications:
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Responsible Party: Ufuk Oguz Idiz, M.D, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02679547    
Other Study ID Numbers: Breastfeeding
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Because the time period of this study is very short
Keywords provided by Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital:
Appendix
Breastfeeding
Adult
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases