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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02679547
Other study ID # Breastfeeding
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 2016
Est. completion date January 2020

Study information

Verified date February 2019
Source Sisli Hamidiye Etfal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1500
Est. completion date January 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Breastfeeding
All of the participants and patients will have a questionnaire about their breastfeeding

Locations

Country Name City State
Turkey Bursa Yuksek Ihtisas Training and Research Hospital Bursa
Turkey Arnavutkoy State Hospital Istanbul
Turkey Bezmialem Vakif University Istanbul
Turkey Istanbul Training and Research Hospital Istanbul
Turkey Sisli Etfal Training and Research Hospital Istanbul

Sponsors (5)

Lead Sponsor Collaborator
Sisli Hamidiye Etfal Training and Research Hospital Arnavutkoy State Hospital, Bezmialem Vakif University, Bursa Yüksek Ihtisas Education and Research Hospital, Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alves JG, Figueiroa JN, Barros I. Does breast feeding provide protection against acute appendicitis? A case-control study. Trop Doct. 2008 Oct;38(4):235-6. doi: 10.1258/td.2008.070404. — View Citation

Minniti F, Comberiati P, Munblit D, Piacentini GL, Antoniazzi E, Zanoni L, Boner AL, Peroni DG. Breast-milk characteristics protecting against allergy. Endocr Metab Immune Disord Drug Targets. 2014 Mar;14(1):9-15. Review. — View Citation

Pisacane A, de Luca U, Impagliazzo N, Russo M, De Caprio C, Caracciolo G. Breast feeding and acute appendicitis. BMJ. 1995 Apr 1;310(6983):836-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The breastfeeding status questionnaire in the appendicitis patients and participants without appendicitis 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
See also
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Active, not recruiting NCT01718275 - Non-operative Management of Early Appendicitis in Children
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