The Use of Chaperone in Routine Anorectal Examination

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Exanimation

Treatments: Other: With Chaperone; Other: Without Chaperone

Study type: Interventional

Funder types: Other

Identifiers

NCT03615586

17-0597

Details and patient eligibility

About

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.

Full 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).

Enrollment: 188 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

With Chaperone

Active Comparator group

Description:

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

Treatment:

Other: With Chaperone

Without Chaperone

Active Comparator group

Description:

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

Treatment:

Other: Without Chaperone