The aim of this clinical trial is to compare short term and long term affects of peritoneal closure with non-closure in an academic medical center.
Design
Two arm parallel group randomized trial, double blind,with blinded postoperative care and outcome assessment and patients, on 200 patients, using random number table for randomization.
Settings and conduct
This double blinded prospective clinical trial will be conducted in Imam Hossein Medical Center; an academic center under supervision of Shahid Beheshti University of Medical Sciences. The included participant will be randomly divided into two groups and in closure group the peritoneum will be sutured before closing the fascia layer and in non-closure group only the fascia layer will be closed at the end of surgery. the patients and the assessment team are blinded.
Participants/Inclusion and exclusion criteria
The inclusion criteria are Laparotomy with midline incision and age of equal or greater than 16.
The exclusion criteria are prior history of laparotomy; diabetes mellitus; known connective tissue disorders; infection; obstetrics surgery; and emergency cases.
Intervention groups
In closure group the peritoneum will be sutured before closing the fascia layer and in non-closure group only the fascia layer will be closed at the end of surgery.
Main outcome variables
Post-op pain intensity by visual analogue scale
Need for analgesic drugs
Surgical wound complications
Incisional hernia and adhesion assessment by physical examination after six months of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200404046936N2
Registration date:2020-04-28, 1399/02/09
Registration timing:registered_while_recruiting
Last update:2020-04-28, 1399/02/09
Update count:0
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Arash Mohammadi Tofigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7758 5851
Email address
arash_mtofigh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of peritoneal closure vs non-closure after non-infected elective laparotomy with midline incision
Public title
"Peritoneal closure in laparotomy"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laparotomy with midline incision
Age of equal or greater than 16
Exclusion criteria:
Prior history of laparotomy
Diabetes mellitus
Known connective tissue disorders
Infection
Obstetrics surgery
Emergency cases
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table patients assign to the closure or non-closure groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator and patient are unaware of the group the patient is enrolled in. All patients are assessed by a resident unaware of the allotted group of the patient in regard of pain intensity, need of analgesic and wound complications and the results are filled in the checklists. Six months after the surgery a known unaware radiologist will perform an abdominal sonography and the result will be registered.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshty University of Medical Sciences
Street address
Evin, Shahid Beheshty University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.SBMU.MSP.REC.1397.430
Health conditions studied
1
Description of health condition studied
peritoneum closure in laparatomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
post-op pain
Timepoint
days 1, 2 and 3 post-op
Method of measurement
visual analogue scale
2
Description
analgesic need
Timepoint
days 1, 2 and 3 post-op
Method of measurement
injection doses
3
Description
infection
Timepoint
first post-op week
Method of measurement
observation
4
Description
duration of hospitalization
Timepoint
first post-op week
Method of measurement
observation
5
Description
Bowel adhesion
Timepoint
6 months after surgery
Method of measurement
sonography device
6
Description
Incisional hernia
Timepoint
6 months after surgery
Method of measurement
Sonography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Closure group in which the peritoneum is closed with absorbable sutures and then the abdominal fascia is closed.
Category
Treatment - Surgery
2
Description
Control group: non-closure group in which at end of surgery only the abdominal fascia layer is sutured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Medical Center
Full name of responsible person
Arash Mohammadi Tofigh
Street address
Shahid Madani st.
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 5851
Email
arash_mtofigh@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
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
Arash Mohammadi Tofigh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Madani st.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 5851
Email
arash_mtofigh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Mohammadi Tofigh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Madani st., Imam Hossein Medical Center
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 5851
Email
arash_mtofigh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Mohammadi Tofigh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Madani st, Imam Hossein Medical Center
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 5851
Fax
+98 21 7758 5851
Email
arash_mtofigh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data of the patients participating in the study will be shared after the study.
When the data will become available and for how long
Data sharing will be possible 6 month after publishing the results.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to continue the study and increase the number of samples and develop the study.
From where data/document is obtainable
Arash Mohammadi Tofigh via email address
arash_mtofigh@yahoo.com
What processes are involved for a request to access data/document
Immediately after receiving the request, the applicant's person or institution will be examined and the requested file will be sent within a week.