Laparotomy is meaning to incision in The abdominal wall area for access to the abdominal cavity is performed in a variety of surgical procedures. Abdominal wall herniation, infection, rupture of the wound (ulceration or muscle layers) and chronic drainage are potential complications of using this procedure. These complications are influenced by various factors. Various articles have compared some of the causes, including absorbable sutures, non-absorbable sutures by monofilaments, multifilament interlocking sutures, and low-absorption sutures (those with 30 days elongation strength). High-uptake sutures (those that lose their tensile strength over a period of 30 days) are referred to as contributors to the modulation of laparotomy complications. Since the suture type is fully controlled by the surgeon, the aim of this study was to compare Simplel and Continius suture in occlusion of fascia in incision midline laparotomy for incisional herniation, wound dehiscence, postoperative pain.
Design
Patients are randomly divided into two treatment groups using Simplex Suture for Reconstruction of Fascia and Suture Contius by matching age and sex variables.
Settings and conduct
In this clinical trial study patients undergoing elective laparotomy in 2019 and 2020 will be enrolled in this study.
Participants/Inclusion and exclusion criteria
In this clinical trial study patients with elective laparotomy will be included in the study. Exclusion criteria included previous abdominal surgery, malignancies, eating disorders, diabetes, ascites, high intra-abdominal pressure, disability, and lack of satisfaction with the study.
Intervention groups
Treated with Simplel suture for repair of fascia and suture cont
Main outcome variables
incidence of fascia dehiscence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160803029181N9
Registration date:2019-12-10, 1398/09/19
Registration timing:registered_while_recruiting
Last update:2019-12-10, 1398/09/19
Update count:0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between simple suture and continuous suture in fascia closure in midline laparotomy
Public title
simple suture versus continuous suture in fascia closure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who needed Elective Laparotomy,will enroll
Exclusion criteria:
Exclusion criteria included previous abdominal surgery, malignancies, eating disorders, diabetes, ascites, high intra-abdominal pressure, disability, and lack of satisfaction with the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two treatment groups using Simplex suture to repair fascia and suture continuous by matching age and sex variables.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and analyzers are blind to the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commity of Shahid Beheshti University of Medicasl Sciences
Street address
Daneshju Avenue Velenjak
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.385
Health conditions studied
1
Description of health condition studied
ELECTIVE LAPARATOMY
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
fascial dehiscence
Timepoint
3,6,12 month after surgery
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:Treated with Simple Suture for fascia repair:
Category
Treatment - Surgery
2
Description
Intervention group 2: Treated with continuous suture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nasser Malekpour
Street address
Modarres Hospital;Kaj Sq;Saadat Abad;
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Fax
+98 21 2206 9355
Email
nassermalekpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziai
Street address
Danshju Ave Velenjak
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4087
Email
aliziai@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
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ShahidBeheshti University Of Medical Sciences,Arabi street,Velenjak.
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2207 4088
Fax
+98 21 2207 4088
Email
nassermalekpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
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