Protocol summary

Study aim
The main purpose of our study was to evaluate the effect of postoperative exercise monitoring therapy in midline laparotomy patients and to evaluate the short-term complications of midline laparotomy.
Design
Study on 40 patients, 20 of whom are in the control group. Randomization will be performed with a simple randomization method with parallel, double-blinded.
Settings and conduct
For patients in the exercise therapy intervention group, exercise will be taught twice daily for 15 minutes under supervision. Duration of hospitalization, the time of gas excretion by the patient during the hospitalization period will be recorded by informing the nursing staff. For this evaluation, the end time of surgery will be considered zero minutes. To evaluate patients' performance, patients will be instructed and measured in a 30-second stand-up test. All measurements will be taken the day after surgery as the pre-intervention point and the day of discharge. The patients will be discharged when the pain is controlled with oral medication, the patient is able to tolerate solid food, and the patient is no longer nauseous and had defecation.
Participants/Inclusion and exclusion criteria
Patients aged 20 to 70 years who are literate and have undergone elective or emergency surgery by midline laparotomy incision in the general surgery ward of Loghman Hakim Hospital.
Intervention groups
For patients in the exercise therapy intervention group, stretching exercises, progressive strength, and functional exercises will be performed twice a day for 15 minutes under supervision. While patients are still in the hospital recovering from surgery.
Main outcome variables
The duration of hospitalization, the duration of gas excretion during hospitalization at the time of discharge, and to evaluate patients' performance, a 30-second post-surgery and 30-day post-surgery test will be measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220430054701N1
Registration date: 2022-05-11, 1401/02/21
Registration timing: prospective

Last update: 2022-05-11, 1401/02/21
Update count: 0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Azadeh Hakakzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9007
Email address
ahakakzade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Supervised exercise therapy in patients treated with midline incision laparotomy: a clinical trial
Public title
Exercise therapy in midline incision laparotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients treated with midline incision laparotomy
Exclusion criteria:
Evidence of recurrent or metastatic disease Use of immunosuppressive drugs Use of (ERAS )enhanced recovery after surgery for postoperative care
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients will be based on simple randomization and with the help of accepted methods to generate a random sequence on the web. The site randomizer.org will be used by filling in the information of the number of patients, and two target groups, assigning an equal number in each group and selecting non-duplicate numbers in this plan. Based on the numbers with random sequences generated on the site, patients will be divided into two groups. The intervention group will be the exercise therapy intervention group and group B, which is the group of routine postoperative interventions will be the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The allocation will be concealed by using opaque, sealed envelopes that were consecutively numbered. Apart from the project coordinator, the patients, attending physician of supervised exercise therapy will be blinded to the intervention allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave., Yemen Blvd., Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.SBMU.MSP.REC.1400.737

Health conditions studied

1

Description of health condition studied
Evaluation of complications of midline laparotomy surgery
ICD-10 code
Y40-Y84
ICD-10 code description
Complications of medical and surgical care

Primary outcomes

1

Description
Any surgical complication
Timepoint
Immediately after surgery, before discharge and 30 days after surgery
Method of measurement
Patient physical exam by the surgeon

2

Description
Hospitalization duration
Timepoint
Immediately after surgery, before discharge
Method of measurement
Checking the patient files

3

Description
Duration of first gas excretion after surgery
Timepoint
Immediately after surgery
Method of measurement
Inform the nurse ward and register on patient file

Secondary outcomes

1

Description
30 seconds chair stand funtional test
Timepoint
Before discharge and 30 days after surgery
Method of measurement
Counting the number of complete repetitions of the standing-sitting cycle

Intervention groups

1

Description
Intervention group: Patients aged 20-70 years treated with elective surgery or emergency with midline laparotomy incision for whom in the exercise therapy intervention group, exercise will be performed twice daily for 15 minutes under supervision during hospitalization
Category
Rehabilitation

2

Description
Control group: Patients aged 20-70 years treated with elective surgery or midline laparotomy incision in the control group, patients will receive routine postoperative support protocol.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Azadeh Hakakzadeh
Street address
Lashkar crossroad, Makhsoos street
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
ahakakzade@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. - Building No. 2 - Fifth Floor
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azadeh Hakakzadeh
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2990 3268
Email
ahakakzade@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azadeh Hakakzadeh
Position
non faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Tehran - Shahid Chamran Highway, Yemen St. - Shahid Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
ahakakzade@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariborz Rashnoo
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tehran - Shahid Chamran Highway, Yemen St. - Shahid Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
fariborz.rashno@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
The study will continue in later phases and with follow-up in subsequent clinical trial studies with other exercise methods
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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