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The Effect of Staple Line Reinforcement on Leakage and Bleeding Rates Following Laparoscopic Sleeve Gastrectomy: A Multi-Center Study

Protocol summary

Study aim
The objective of this study was to investigate the bleeding and leakage rates following laparoscopic sleeve gastrectomy in patients with morbid obesity (Class II and Class III) after improving the surgical technique.
Design
An interventional clinical trial without a control group, non-blinded, on 107 patients to investigate the effect of staple line reinforcement on leakage and bleeding rates following laparoscopic sleeve gastrectomy
Settings and conduct
In this interventional study, 107 morbidly obese patients aged > 18 years old who underwent LSG at two hospitals in Tehran (an academic hospital and a private hospital) were evaluated. All morbidly obese patients underwent surgery by an expert bariatric surgeon. To ensure consistency and accuracy, the laparoscopic technique and the surgeon were the same for all patients. Polyglyconate and polydioxanone thread, both in full thickness, were used to reinforce the staple line.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI ≥ 40 kg/m², or ≥ 35 kg/m² with at least one comorbidity such as obstructive sleep apnea, diabetes, hypertension, obesity hypoventilation syndrome, hyperlipidemia, Pickwickian syndrome, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis, severe urinary incontinence, impaired quality of life, disqualified from another surgery due to obesity like surgery for osteoarthritis or ventral hernia repair or stress urinary incontinence (SUI) Exclusion Criteria: Age less than 18 years old, BMI < 35 kg/ m², diseases of the digestive tract, history of bariatric surgery, fundoplica
Intervention groups
Reinforcing the staple line with polyglyconate and polydioxanone sutures during a laparoscopic sleeve gastrectomy
Main outcome variables
Anastomotic leakage; Bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250109064325N1
Registration date: 2025-02-15, 1403/11/27
Registration timing: retrospective

Last update: 2025-02-15, 1403/11/27
Update count: 0
Registration date
2025-02-15, 1403/11/27
Registrant information
Name
Sina Eskandari Delfan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2618
Email address
eskandari.si@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-11-01, 1401/08/10
Actual recruitment start date
2021-12-31, 1400/10/10
Actual recruitment end date
2022-11-01, 1401/08/10
Trial completion date
empty
Scientific title
The Effect of Staple Line Reinforcement on Leakage and Bleeding Rates Following Laparoscopic Sleeve Gastrectomy: A Multi-Center Study
Public title
The Effect of Staple Line Reinforcement on Leakage and Bleeding Rates Following Laparoscopic Sleeve Gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI ≥ 40 kg/m², or ≥ 35 kg/m² with at least one comorbidity such as obstructive sleep apnea, diabetes, hypertension, obesity hypoventilation syndrome, hyperlipidemia, Pickwickian syndrome, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis, severe urinary incontinence, impaired quality of life, disqualified from another surgery due to obesity like surgery for osteoarthritis or ventral hernia repair or stress urinary incontinence (SUI)
Exclusion criteria:
age less than 18 years old, BMI < 35 kg/ m², diseases of the digestive tract, history of bariatric surgery, fundoplication, coagulation disorders, severe anemia (hemoglobin < 5 g/dL), and use of corticosteroids
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 107
Actual sample size reached: 107
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sciences ethics committee
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.358

Health conditions studied

1

Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
Other obesity

Primary outcomes

1

Description
Anastomotic leakage
Timepoint
During the first 7 days and between the 1st and 6th week
Method of measurement
Radiographic evidence, reoperation to repair the anastomotic leak, percutaneous drain placement, endoscopic stent placement, abdominal abscess formation or antibiotic use for intra-abdominal abscess

Secondary outcomes

1

Description
Bleeding
Timepoint
During the first 7 days and between the 1st and 6th week
Method of measurement
re-surgery for bleeding control, blood transfusion, unexplained hemoglobin drops to less than 10 g/dL, or unexplained hematocrit drops of more than 30% if there is no specific reason for it

Intervention groups

1

Description
Intervention group: Reinforcing the staple line with polyglyconate and polydioxanone sutures during a laparoscopic sleeve gastrectomy
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Imam Khomeini Hospital
Full name of responsible person
Ali Gandominejad
Street address
Imam Khomeini Hospital, Keshavarz blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2618
Fax
Email
ali.gandominejad71@gmail.com

2

Recruitment center
Name of recruitment center
Laleh specialized and super-specialized hospital
Full name of responsible person
Ali Gandominejad
Street address
Corner of South Shajarian St. (South Flamek), Simai Iran St., Phase 5, Shahrak Gharb,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8856 3020
Email
ali.gandominejad71@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor For Research, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences Building,Gods St., Keshavarz Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Fax
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Gandominejad
Position
General Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital surgery ward, Keshavarz blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2618
Fax
Email
ali.gandominejad71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Gandominejad
Position
General Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital surgery ward, Keshavarz blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2618
Email
ali.gandominejad71@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Gandominejad
Position
General Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital surgery ward, Keshavarz blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2618
Email
ali.gandominejad71@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be shared after blinding of datasheet.
When the data will become available and for how long
The data access period is 6 months after the results are published.
To whom data/document is available
Data will be accessible for researchers affiliated to universities.
Under which criteria data/document could be used
Data can be used for further meta-analysis after permission of the person responsible for this project.
From where data/document is obtainable
Data request should be sent through email for the person responsible for this project. Dr. Ali Gandominejad ali.gandominejad71@gmail.com
What processes are involved for a request to access data/document
Following the primary request, all the researchers will be informed by the responsible person and after permission the data will be shared.
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