TROCAR SITE HERNIA AFTER LSG
Primary Purpose
Obesity, Morbid, Hernia Incisional
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CTSP
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity, Morbid focused on measuring Laparoscopic Sleeve Gastrectomy, Morbid obesity, Trocar site hernia, Carter Thomasson Suture Passer
Eligibility Criteria
Inclusion Criteria:
- The patients above 18 years old.
- The patient who went Laparoscopic Sleeve Gastrectomy (LSG) procedure for morbid obesity.
Exclusion Criteria:
- The patients who needed to have additional surgery after the LSG in their follow up.
- The patients who could not reached and did not attend to the Ultrasound examination.
- The patient who did not approve the participate to the study.
Sites / Locations
- Anıl Ergin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
The group USG was applied
Arm Description
USG was applied to the patients who underwent Laparoscopic sleeve gastrectomy for research trocar site hernia after 2-4 years from the surgery. Carter Thomasson suture passer was used to close fascial defect in all patients.
Outcomes
Primary Outcome Measures
incidence of incisional hernia
Superficial abdominal Ultrasound for the incisional hernia to trocar sites.
Secondary Outcome Measures
Full Information
NCT ID
NCT04849403
First Posted
April 10, 2021
Last Updated
April 13, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04849403
Brief Title
TROCAR SITE HERNIA AFTER LSG
Official Title
EVALUATION OF THE FREQUENCY OF TROCAR SITE HERNIA AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Today, laparoscopic sleeve gastrectomy (LSG) has become the most frequently performed bariatric surgical method. One of the complications seen after LSG is trocar site hernia (TSH). There is no clear information about the rate of TSH detected radiologically after LSG. Thick abdominal wall and failure to adequately expose the facial defect related to this, mobility limitations due to excessive subcutaneous fatty tissue are the reasons accused for increased incidence of TSH.
Demographic characteristics and postoperative weight loss of patients who underwent LSG procedure in our clinic between January 2015 and June 2017 and whose facial defects in the trocar region were repaired with the Carter-Thomason Suture Passer (CTSP) were evaluated. TSH evaluation was made both by physical examination and superficial USG by a general surgeon who had radiological training on concurrent superficial abdominal ultrasonography (USG). Detected TSHs were divided into two groups as symptomatic and asymptomatic.
Detailed Description
This study included 61 patients who applied to the obesity follow-up outpatient clinic for any complaints or routine control over a 3-month period or who were called by telephone for control and who underwent laparoscopic sleeve gastrectomy for morbid obesity between January 2015- June 2017. Patients with symptoms associated with trocar site hernia were also included in the study, while patients with multiple bariatric surgical procedures or abdominal operations were excluded. Physical examinations to detect hernias were performed both in standing and supine positions for all patients and also during increased abdominal pressure by the Valsalva maneuver. All abdominal incision sites were examined. On physical examination, a hernia was defined as a bulging during the Valsalva maneuver and palpation of the fascial defect. USG was performed (Figure I,II) by a clinician who had previously received superficial USG evaluation training for trocar site hernia with a GE pro 500, 3 MHz and abdominal incision sites were investigated for the presence of hernias.
The trocar entry localizations of the patients were all the same and are as follows: one 15-mm camera trocar (supraumbilical) , one 10-mm working trocar (left upper quadrant), two 5-mm working trocars (right and left upper quadrant) and one 5-mm liver retractor. Trocar entry localizations are shown in Figure III. During fascia closure procedure, No. 0 absorbable suture (PolyglactinYü-ce Vicryl Ⓡ, Tekirdag, Turkey ) was used with the CTSP (Figure IV). The collected data were recorded in a pre-established database with age, gender, Diabetes Mellitus (DM), postoperative follow-up period, BMI at the time of operation and BMI during superficial USG.
This study was approved by the Ethics Committee of University of Health Sciences Istanbul Fatih Sultan Mehmet Training and Research Hospital (12.09.2019 / 80).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Hernia Incisional
Keywords
Laparoscopic Sleeve Gastrectomy, Morbid obesity, Trocar site hernia, Carter Thomasson Suture Passer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
61 patients who underwent Laparoscopic Sleeve Gastrectomy are included. USG was performed (Figure I,II) by a clinician who had previously received superficial USG evaluation training for trocar site hernia and abdominal incision sites were investigated for the presence of hernias.
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The group USG was applied
Arm Type
Other
Arm Description
USG was applied to the patients who underwent Laparoscopic sleeve gastrectomy for research trocar site hernia after 2-4 years from the surgery. Carter Thomasson suture passer was used to close fascial defect in all patients.
Intervention Type
Procedure
Intervention Name(s)
CTSP
Intervention Description
In all patients Carter Thomasson Suture Passer (CTSP) were used for closing fascial defect peroperatively
Primary Outcome Measure Information:
Title
incidence of incisional hernia
Description
Superficial abdominal Ultrasound for the incisional hernia to trocar sites.
Time Frame
2-4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients above 18 years old.
The patient who went Laparoscopic Sleeve Gastrectomy (LSG) procedure for morbid obesity.
Exclusion Criteria:
The patients who needed to have additional surgery after the LSG in their follow up.
The patients who could not reached and did not attend to the Ultrasound examination.
The patient who did not approve the participate to the study.
Facility Information:
Facility Name
Anıl Ergin
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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TROCAR SITE HERNIA AFTER LSG
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