Protocol summary

Study aim
Investigating the effect of pre-preparation programs for patients candidates for elective hepatopancreatic biliary surgery on the rate of complications after surgery and length of hospitalization.
Design
information regarding age, gender, ethnicity, occupation, education level, history of illnesses and hospitalization, surgeries, and history of medication and supplements was collected from individuals using a general questionnaire. Then, before randomly assigning individuals to two groups, measurements such as body weight, blood tests, quality of life questionnaires, and a 6-minute walk test were conducted. Before the intervention began, individuals were initially grouped based on age (20 to 30, 30 to 40, 40 to 50, and 50 to 70 years) and gender (male and female) in pairs.
Settings and conduct
The present study was conducted as a randomized controlled clinical trial with the aim of determining the effect of pre-preparation programs received in patients who are candidates for elective hepatopancreaticobiliary surgery. In this study, sampling was done in Shariati Hospital, Tehran, and sampling was done randomly, and eligible people were selected based on entry and exit criteria
Participants/Inclusion and exclusion criteria
Over 18 years old Patients with hepatic, pancreatic, or biliary cancer Willingness to participate in the study No chemotherapy received 1 month prior to surgery Metastatic hepatic, pancreatic, or biliary cancer Serious allergy to specific drugs or food Following a specific diet for 3 months prior Use of any amount of supplements in the past 3 months
Intervention groups
Over 18 years Patients with hepatopancreaticobiliary cancer Willingness to participate in the study Not receiving chemotherapy 1 month before surgery
Main outcome variables
weight (kg) body mass index (kg/m2) INR Albumin Length of hospitalization Length of stay in ICU 6 minutes walk Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240212060973N1
Registration date: 2024-05-14, 1403/02/25
Registration timing: registered_while_recruiting

Last update: 2024-05-14, 1403/02/25
Update count: 0
Registration date
2024-05-14, 1403/02/25
Registrant information
Name
Amirhossein khormani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8857 7237
Email address
amirhossein_khormani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-07-15, 1403/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of pre-habilitation for patients preparing for elective Hepato-Pancerato Biliary (HBP) surgery on postoperative complications and length of hospital stay
Public title
The effectiveness of pre-habilitation for patients preparing for elective Hepato-Pancerato Biliary (HBP) surgery on postoperative complications and length of hospital stay
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old • Patients with hepatopancreaticobiliary cancer • Having a desire to participate in the study • Not receiving chemotherapy 1 month before surgery
Exclusion criteria:
• Metastatic hepatopancreaticobiliary cancers • Having a serious allergy to certain drugs or foods • Following a special diet during the 3 months prior to the study • Taking any amount of supplements during the past 3 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
From the selection of people based on the mentioned criteria and the consent of the people to participate in the study, information about age, gender, ethnicity, occupation, education level, history of diseases and hospitalization, surgery and history of taking drugs and supplements using a A general questionnaire was taken from people. Then, before randomly assigning people to two groups, anthropometric measurements, blood tests, quality of life questionnaires and 6 minutes of walking were performed. Before starting the intervention, people were divided into two groups according to age (20 to 30, 30 to 40, 40 to 50, and 50 to 70 years), and gender (male and female). Every person qualified to enter the study was examined in terms of these two indicators. For each person with two specific characteristics, another person with similar conditions in terms of these two indicators was selected. In fact, based on having each of the two categories related to these two characteristics, a person would be placed in one of nine possible states. Then random assignment of both people in the same state to intervention and non-intervention groups was done. All the information related to different stages, including the initial entry of patients, random allocation, follow-up and the rate of leakage and analyzes were according to the flowchart of clinical trials such as Consort.
Blinding (investigator's opinion)
Single blinded
Blinding description
From the selection of people based on the mentioned criteria and the consent of the people to participate in the study, information about age, sex, ethnicity, occupation, education level, history of diseases and hospitalization, surgery and history of taking drugs and supplements using a A general questionnaire was taken from people. Then, before randomly assigning people to two groups, anthropometric measurements, blood tests, quality of life questionnaires and 6 minutes of walking were performed. Before starting the intervention, people were divided into two groups according to age (20 to 30, 30 to 40, 40 to 50, and 50 to 70 years), and gender (male and female). Every person qualified to enter the study was examined in terms of these two indicators. For each person with two specific characteristics, another person with similar conditions in terms of these two indicators was selected. In fact, based on having each of the two categories related to these two characteristics, a person would be placed in one of nine possible states. Then random assignment of both people in the same state to intervention and non-intervention groups was done. All the information related to different stages, including the initial entry of patients, random allocation, follow-up and the rate of leakage and analyzes were according to the flowchart of clinical trials such as Consort.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2022-12-31, 1401/10/10
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1401.019

Health conditions studied

1

Description of health condition studied
Hepatopancreaticobiliary Cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Albumin
Timepoint
Before the intervention, 21 days after the intervention
Method of measurement
lab data

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first intervention group: the group that received Peptamen nutritional supplement made by Nestlé and received psychological counseling and respiratory physiotherapy programs.
Category
Rehabilitation

2

Description
Control group:The control group that did not receive the intervention. And according to the previous routine, the candidate was operated after visiting the clinic.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
shariati hospital
Full name of responsible person
Nasir Fakhar
Street address
Jalal-e-Al-e-Ahmad Hwy, 14117
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasir Fakhar
Street address
Jalal-e-Al-e-Ahmad Hwy, 14117
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences grant
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
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Khormani
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Jalal-e-Al-e-Ahmad Hwy, 14117
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
amirhossein_khormani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhosein khormani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Jalal-e-Al-e-Ahmad Hwy, 14117
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
amirhossein_khormani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein khormani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Jalal-e-Al-e-Ahmad Hwy, 14117
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
amirhossein_khormani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect patient privacy
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The study data will be provided to the researchers upon request through the person in charge of the project.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
researchers
Under which criteria data/document could be used
The datasets generated and/or analyzed during the current study are not publicly available, but are available from the corresponding author at reasonable request.
From where data/document is obtainable
Email should be sent to the correspond
What processes are involved for a request to access data/document
The request should be made via email.
Comments
Loading...