Protocol summary

Study aim
The aim of this study, which would also contribute to the nursing literature, was to assess the impact of food pictures shown to patients who underwent surgery for rectal cancer on postoperative recovery of intestinal motility.
Design
This is a non-randomized, experimental study. We carried out with 48 patients who underwent rectal surgery because of colorectal cancer in the general surgery clinic of a university hospital in Turkey. In this study, we used a convenience sample method.
Settings and conduct
It included patients who volunteered to monitor food pictures in the experimental group, and it included the patients who reported that they did not want to monitor food pictures in the control group. A booklet of food pictures was given and presented to the patients in the experimental group. From the first morning after surgery until defecation, patients in the experimental group were asked to monitor food pictures thrice a day, parallel to their meals.
Participants/Inclusion and exclusion criteria
Patients aged over 18 years who underwent open rectal surgery due to colorectal cancer, did not receive epidural anesthesia or analgesia in the intraoperative or postoperative period, had no nasogastric catheter, were mobilized within 24 hours during the post-operative period and whose surgery was performed by the same surgeon were included in the sample. Patients were excluded who have complications developed during or after surgery and need treatment in the intensive care unit after surgery.
Intervention groups
From the first morning after surgery until defecation, patients in the experimental group were asked to monitor food pictures thrice a day, parallel to their meals.
Main outcome variables
Flatus and defecation times of the patients were followed and written on the data collection form.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210513051286N1
Registration date: 2021-05-23, 1400/03/02
Registration timing: retrospective

Last update: 2021-05-23, 1400/03/02
Update count: 0
Registration date
2021-05-23, 1400/03/02
Registrant information
Name
Sacide Yildizeli Topcu
Name of organization / entity
Trakya University Faculty of Health Sciences
Country
Turkey
Phone
+90 284 213 30 42
Email address
sacideyildizeli@trakya.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-18, 1395/02/29
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
2016-05-18, 1395/02/29
Actual recruitment end date
2018-12-06, 1397/09/15
Trial completion date
2018-12-06, 1397/09/15
Scientific title
MONITORING FOOD IMAGES AFTER RECTAL SURGERY TO ACCELERATE RECOVERY OF POSTOPERATIVE BOWEL MOTILITY: A QUASI-EXPERIMENTAL STUDY
Public title
EFFECT OF MONITORING FOOD IMAGES AFTER RECTAL SURGERY
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent open rectal surgery due to colorectal cancer Patients who did not receive epidural anesthesia or analgesia in the intraoperative or postoperative period Patients who had no nasogastric catheter Patients who were mobilized within 24 hours during the post-operative period Patients whose surgery was performed by the same surgeon
Exclusion criteria:
Patients who have complications developed during or after surgery Patients who need treatment in the intensive care unit after surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Actual sample size reached: 48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Trakya University Faculty of Medicine Scientific Research Ethics Committee
Street address
Trakya University Balkan Campus
City
Edirne
Postal code
22020
Approval date
2016-04-07, 1395/01/19
Ethics committee reference number
07/16

Health conditions studied

1

Description of health condition studied
Postoperative bowel motility
ICD-10 code
K56.0
ICD-10 code description
Paralytic ileus

2

Description of health condition studied
Postoperative complications
ICD-10 code
R19.4
ICD-10 code description
Change in bowel habit

3

Description of health condition studied
Postoperative motility of digestive system
ICD-10 code
K91.8
ICD-10 code description
Other intraoperative and postprocedural complications and disorders of digestive system

Primary outcomes

1

Description
Postoperative first flatus time
Timepoint
Postoperative 1. day and following days
Method of measurement
Postoperative first flatus time were followed as day.

2

Description
Postoperative first defecation time
Timepoint
Postoperative 1. day and following days.
Method of measurement
Postoperative first defecation time were followed as day.

Secondary outcomes

empty

Intervention groups

1

Description
A food pictures booklet was prepared for the patients in the experimental group. This 30-page booklet included different and colorful photographs of foods and fruits.The researchers performed the clinical daily visits to determine the patients who met the sampling criteria and were to undergo planned rectal surgery. And then, information about the aim and application of the study was given to the patients, and patients who volunteered to participate in the study were included in the study.It included patients who volunteered to monitor food pictures in the experimental group, and it included the patients who reported that they did not want to monitor food pictures in the control group.50 patients, including 25 patients in each group, were assigned to the study. Two patients who were in the experimental group excluded from the sample because they resisted watching food pictures during the data collection process. Consequently, the study was conducted with 48 patients. Patients in each group received the routine postoperative care applied in the clinic. From the first morning after surgery until defecation, patients in the experimental group were asked to monitor food pictures thrice a day, parallel to their meals. Flatus and defecation times of the patients were followed and written on the data collection form.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Trakya University Faculty of Health Sciences
Full name of responsible person
Sacide Yildizeli Topcu
Street address
Trakya University Faculty of Health Sciences
City
Edirne
Postal code
22020
Phone
+90 284 213 30 42
Fax
+90 284 212 61 07
Email
sacideyildizeli@trakya.edu.tr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Trakya University Faculty of Health Sciences
Full name of responsible person
Sacide Yildizeli Topcu
Street address
Trakya University Faculty of Health Sciences
City
Edirne
Postal code
22020
Phone
+90 284 213 30 42
Fax
+90 284 212 61 07
Email
sacideyildizeli@trakya.edu.tr
Web page address
https://personel-en.trakya.edu.tr/sacideyildizeli/#.YKI3o7UzbIU
Grant name
Trakya University Faculty of Health Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Trakya University Faculty of Health Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Trakya University Faculty of Health Sciences
Full name of responsible person
Sacide Yildizeli Topcu
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Surgical Nursing
Street address
Trakya University Faculty of Health Sciences
City
Edirne
Province
Merkez
Postal code
22020
Phone
+90 284 213 30 42
Fax
+90 284 212 61 07
Email
sacideyildizeli@trakya.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Trakya University Faculty of Health Sciences
Full name of responsible person
Sacide Yildizeli Topcu
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Surgical Nursing
Street address
Trakya University Faculty of Health Sciences
City
Edirne
Province
Merkez
Postal code
22020
Phone
+90 284 213 30 42
Fax
+90 284 212 61 07
Email
sacideyildizeli@trakya.edu.tr

Person responsible for updating data

Contact
Name of organization / entity
Trakya University Faculty of Health Sciences
Full name of responsible person
Sacide Yildizeli Topcu
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Surgical Nursing
Street address
Trakya University Faculty of Health Sciences
City
Edirne
Province
Merkez
Postal code
22020
Phone
+90 284 213 30 42
Fax
+90 284 212 61 07
Email
sacideyildizeli@trakya.edu.tr

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only IPD collected for the primary outcome measure will be shared.
When the data will become available and for how long
Documents/data files will become available starting 1 year after publication.
To whom data/document is available
Deidentified IPD and any additional supporting information/documents will be shared for people working in academic institutions.
Under which criteria data/document could be used
Deidentified IPD and any additional supporting information/documents will be shared by corresponding author via e-mail.
From where data/document is obtainable
Sacide YILDIZELI TOPCU e-mail: sacideyildizeli@trakya.edu.tr
What processes are involved for a request to access data/document
One year after the publication of the article containing study reports, the responsible author can be contacted via e-mail for receiving the documents /data files
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