NCT02679547

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

February 3, 2016

Last Update Submit

February 16, 2019

Conditions

Appendicitis

Keywords

AppendixBreastfeedingAdult

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Appendicitis

The patients with appendicitis

Other: Breastfeeding

Control

The participants without appendicitis

Other: Breastfeeding

Interventions

BreastfeedingOTHER

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

AppendicitisControl

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Subjects has pathologically proven appendicitis for appendicitis group.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

Sisli Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Arnavutkoy State Hospital

Istanbul, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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. doi: 10.2174/1871530314666140121145045.

    PMID: 24450452BACKGROUND

  • 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. doi: 10.1136/bmj.310.6983.836. No abstract available.

    PMID: 7711621BACKGROUND

  • 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.

    PMID: 18820196BACKGROUND

MeSH Terms

Conditions

AppendicitisBreast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 10, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

TU(5)