The Use of Chaperone in Routine Anorectal Examination

NCT ID: NCT03615586

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2020-07-27

Brief Summary

Background and aim: The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. The aim of this study is to compare the patients' perception and preference regarding the presence of a chaperone during their first anorectal examination. Patients and methods: adult women will be randomly selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present in that clinical situation. The patients will prospectively enrolled in one of the two groups of this randomized trial during a period of two years.

Detailed Description

The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. However, there are some guidance saying says that doctors should offer the patient the option of a chaperone wherever possible before conducting an intimate examination. The aim of this study is to compare the female patients' perception and preference regarding the presence of a chaperone during their first anorectal examination conduct by a male physician. Adult women will be investigated during their first visit to a Coloproctology Clinic at University Hospital. Only senior professionals will be examining the patients. This will be a prospectively randomized trial. Patients will be selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present during the anorectal examination. The enrollment period will be two years from July 2018. Sample size estimated for the study is 188 patients (94 in each study group).

Conditions

Exanimation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

With Chaperone

Female patients examined by male physicians in the presence of a female (nurse) chaperone. The intervention consists of the presence of a female chaperone.

Group Type: ACTIVE_COMPARATOR

With Chaperone

Intervention Type: OTHER

Female patients examined by male physicians in the presence of a female (nurse) chaperone.

Without Chaperone

Female patients examined by male physicians without a chaperone. The intervention is the absence of a female chaperone.

Group Type: ACTIVE_COMPARATOR

Without Chaperone

Intervention Type: OTHER

Female patients examined by male physicians without the presence of a female (nurse) chaperone.

Interventions

With Chaperone

Female patients examined by male physicians in the presence of a female (nurse) chaperone.

Intervention Type: OTHER

Without Chaperone

Female patients examined by male physicians without the presence of a female (nurse) chaperone.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adult female patients;
• first visit to our Coloproctology clinic;
• signed consent form

Exclusion Criteria

• patients previously submitted to anorectal examination;
• refusal of participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel C Damin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Daniel C Damin, MD, PhD

Role: CONTACT

damin@terra.com.br

55-51-996020442

Paulo C Contu, MD

Role: CONTACT

contu@terra.com.br

55-51-99987-5051

Facility Contacts

Daniel C Damin

Role: primary

damin@terra.com.br

5551996020442 ext. 5551996020442

References

Gawande A. Naked. N Engl J Med. 2005 Aug 18;353(7):645-8. doi: 10.1056/NEJMp058120. No abstract available.

Reference Type: BACKGROUND

PMID: 16107618 (View on PubMed)

Stagno SJ, Forster H, Belinson J. Medical and osteopathic boards' positions on chaperones during gynecologic examinations. Obstet Gynecol. 1999 Sep;94(3):352-4. doi: 10.1016/s0029-7844(99)00301-4.

Reference Type: BACKGROUND

PMID: 10472858 (View on PubMed)

Ehrenthal DB, Farber NJ, Collier VU, Aboff BM. Chaperone use by residents during pelvic, breast, testicular, and rectal exams. J Gen Intern Med. 2000 Aug;15(8):573-6. doi: 10.1046/j.1525-1497.2000.10006.x.

Reference Type: BACKGROUND

PMID: 10940150 (View on PubMed)

Conway S, Harvey I. Use and offering of chaperones by general practitioners: postal questionnaire survey in Norfolk. BMJ. 2005 Jan 29;330(7485):235-6. doi: 10.1136/bmj.38320.472986.8F. Epub 2004 Dec 16. No abstract available.

Reference Type: BACKGROUND

PMID: 15604154 (View on PubMed)

Whitford DL, Karim M, Thompson G. Attitudes of patients towards the use of chaperones in primary care. Br J Gen Pract. 2001 May;51(466):381-3.

Reference Type: BACKGROUND

PMID: 11360703 (View on PubMed)

Teague R, Newton D, Fairley CK, Hocking J, Pitts M, Bradshaw C, Chen M. The differing views of male and female patients toward chaperones for genital examinations in a sexual health setting. Sex Transm Dis. 2007 Dec;34(12):1004-7. doi: 10.1097/OLQ.0b013e3180ca8f3a.

Reference Type: BACKGROUND

PMID: 17621250 (View on PubMed)

Damin DC, Contu PC, Savaris RF, Biazi B. Women's preferences regarding the use of chaperones during proctological examinations conducted by male physicians: a randomised clinical trial. Int J Colorectal Dis. 2025 Jan 2;40(1):3. doi: 10.1007/s00384-024-04796-4.

Reference Type: DERIVED

PMID: 39745520 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-0597

Identifier Type: -

Identifier Source: org_study_id