A study of whether videos explaining surgery help patients understand during informed consent for colorectal cancer surgery.

JRCT ID: jRCT1030220383

Registered date:16/10/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 16/10/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Patients scheduled to undergo colorectal cancer resection surgery will be divided into two groups: those who will watch a video explaining the surgery before receiving informed consent from their doctor, and those who will not.

Outcome(s)

• Primary Outcome: The same questionnaire was used for both groups. The comprehension of informed consent, satisfaction, clarity of explanation, and attitude of the doctor will be evaluated on a 5-point Likert scale. The patients were also asked questions to evaluate their level of understanding and to score their understanding.

Secondary Outcome

Patient background will be analyzed in terms of age, gender, educational background, time elapsed since tumor discovery, presence of a patient present when viewing the video, type of disease, surgical procedure, presence of symptoms, and ASA-PS.
A questionnaire will be administered to physicians and nurses who provide explanations to patients to determine whether there was an improvement in patient understanding and satisfaction or a reduction in the burden on the medical staff when using the surgical explanation videos.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients scheduled for colorectal cancer resection surgery in our department
(2) Patients who are 20 years of age or older at the time of consent
(3) Patients who have given written consent for this study

Exclude criteria

(i) Patients under 20 years old
(ii) Patients whose consent could not be obtained after the research was explained to them
(iii) Patients deemed ineligible by the attending physician, such as uninformed or undecided policy prior to informed consent

Related Information

• Primary Sponsor: Hirano Yasumitsu
• Secondary Sponsor: Ishikawa Shintaro,Saitama Medical University International Medical Center, Department of Gastroenterology, Lower Gastrointestinal Tract Surgery Research Fund