Effect of coffee consumption compared to control group on bowel function improvement after abdominal hysterectomy
Design
In the control group from the first day after surgery, routine procedures were performed after abdominal hysterectomy. Surgery In addition to routine procedures, the patient drinks 100 ml (5 g) of the branded coffee drink Nestle every 6 hours (up to 3 times).
Block random sampling
One-blind randomization
The sample size calculated in each group is 17 persons. Including 15% drop in total of 40 people
Settings and conduct
The study will begin in teaching hospitals of Mashhad University of Medical Sciences.
In the control group from the first day after surgery, routine procedures were performed after abdominal hysterectomy. Surgery In addition to routine procedures, 100 ml (5 g) branded coffee drink (Nestle) is consumed every 6 hours (up to 3 times) by the patient.
Participants/Inclusion and exclusion criteria
Patients who underwent abdominal hysterectomy due to benign disease (AUB, fibroma, adenomyosis) with less than 2 and a half hours surgery were included.
Exclusion criteria:
Allergies or allergies to caffeine compounds;
Inflammatory bowel disease;
Liver dysfunction;
Heart arrhythmia;
Chronic constipation (less than or equal to twice a week);
History of bowel surgery;
Abdominal radiotherapy or intraperitoneal chemotherapy history;
Patient transfer to ICU after abdominal hysterectomy;
Need to insert NGT during web immediately after hysterectomy;
Hypertension;
Intervention groups
Intervention group receiving coffee and control group receiving coffee essence
Main outcome variables
The primary outcome to be considered is the time of the patient's first gas discharge. Secondary outcomes include time to first bowel movements, time to first bowel movement, solid diet tolerance, length of stay, and postoperative complications until patient admission.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200116046153N1
Registration date:2020-04-04, 1399/01/16
Registration timing:prospective
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
zahra behnam rassouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 0557
Email address
zbehnam71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coffee consumption on improving bowel function after abdominal hysterectomy compared to routine nutritional regime
Public title
The effect of coffee consumption on improving bowel function after abdominal hysterectomy compared to routine nutritional regime
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing abdominal hysterectomy due to benign disease
The duration of surgery is less than 2 and a half hours
Exclusion criteria:
Allergies or allergies to caffeine compounds
Inflammatory bowel disease
Liver dysfunction
Heart arrhythmia
Chronic constipation
History of bowel surgery
Abdominal radiotherapy or intraperitoneal chemotherapy history
Patient transfer to ICU after abdominal hysterectomy
Need to insert NGT during web immediately after hysterectomy
Hypertension
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block
Quadruple blocks produced by Randomization.com
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors and patients are unaware of the allocation group due to placebo use, and using the A and B codes instead of the group names, the information analyst will also be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Tehran, Qods Town (West), between South Flamak and Zarafshan, Iran Sima Street - Central Headquarters of Ministry of Health and Medical Education, Block A, 13th Floor
City
Mashhad
Province
Razavi Khorasan
Postal code
1111111111
Approval date
2019-11-18, 1398/08/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.728
Health conditions studied
1
Description of health condition studied
Ileus after abdominal hysterectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the time of the patient's first gas discharge
Timepoint
Every 8 hours after intervention
Method of measurement
The patient is instructed to announce the time of first gas excretion
2
Description
time to first bowel movements
Timepoint
Every 8 hours after intervention
Method of measurement
Control of the timing of the first intestinal movements by the researcher by checking the timing of the onset of intestinal sounds
3
Description
time to first defication
Timepoint
Every 8 hours after intervention
Method of measurement
The patient is instructed to announce the time of first defication
4
Description
time to solid diet tolerance
Timepoint
Every 8 hours after intervention
Method of measurement
Controlling patient solid diet tolerance time by a researcher
5
Description
length of stay in hospital
Timepoint
daily after intervention
Method of measurement
Controlling the number of days a patient is hospitalized by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in the morning after surgery, in addition to routine measures, 100 ml coffee drink (5 g) of Nestle branded coffee is consumed by the patient every 6 hours (up to 3 times).
Category
Prevention
2
Description
Control group: In the control group, from the first day after surgery, routine procedures are performed after abdominal hysterectomy and a solution containing 100 ml of edible color and essence of coffee is given three times every 6 hours up to three times.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Behnam Rassouli
Street address
Khorasan Razavi, Mashhad, Farsi Boulevard, Shahid Javan and Ali Shahidi Square, Knowledge and Health City
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3804 9051
Email
p.relations@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Khorasan Razavi, Mashhad, University Street, Next to Hoveizeh Cinema, Qureshi Building, Vice-Chancellor for Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?