AppendicitisNCT02679547
The Effect of Breastfeeding on the Development of Appendicitis in Adults
An observational study of Appendicitis, run by Sisli Hamidiye Etfal Training and Research Hospital at 5 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis
- What is being tested?
- Breastfeeding
- How many people
- 1,500 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- Jan 2016to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 500 patients who has pathologically proven appendicitis, and 1000 participants without appendicitis.
Who may be able to join
- Subjects has pathologically proven appendicitis for appendicitis group.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Sisli Etfal Training and Research Hospital
Istanbul, 34371
Arnavutkoy State Hospital
Istanbul
Bezmialem Vakif University
Istanbul
Istanbul Training and Research Hospital
Istanbul
About this study
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.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- Breastfeeding
- Keywords
- Appendix, Breastfeeding, Adult
- Medical subject headings
- Appendicitis, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingOther
All of the participants and patients will have a questionnaire about their breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Appendicitis | The patients with appendicitis Receives: Other: Breastfeeding | |
| Control | The participants without appendicitis Receives: Other: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Training and Research Hospital, Bezmialem Vakif University, Arnavutkoy State Hospital, Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679547
- Sponsor's protocol ID
- Breastfeeding
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Because the time period of this study is very short
Publications
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.
PubMed 24450452Pisacane 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.
PubMed 7711621Alves 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.
PubMed 18820196
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding on the Development of Appendicitis in Adults
- ClinicalTrials.gov ID
- NCT02679547
- Acronym / sponsor ID
- Breastfeeding
- Conditions
- Appendicitis
- Keywords
- Appendix, Breastfeeding, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Collaborators
- Istanbul Training and Research Hospital, Bezmialem Vakif University, Arnavutkoy State Hospital, Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appendicitis | – | Other: BreastfeedingThe patients with appendicitis |
| Control | – | Other: BreastfeedingThe participants without appendicitis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 500 patients who has pathologically proven appendicitis, and 1000 participants without appendicitis.
Key inclusion criteria (1 listed)
- Subjects has pathologically proven appendicitis for appendicitis group.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreastfeedingAll of the participants and patients will have a questionnaire about their breastfeeding | Other | Appendicitis, Control |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 24450452Minniti 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.
- Background: PubMed 7711621Pisacane 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.
- Background: PubMed 18820196Alves 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.
- Individual participant dataSharing planned: Undecided. Because the time period of this study is very short
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Sisli Hamidiye Etfal Training and Research Hospital at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The breastfeeding status questionnaire in the appendicitis patients and participants without appendicitis (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679547, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.