TROCAR SITE HERNIA AFTER LSG

Obesity, Morbid Clinical Trial

Official title:

EVALUATION OF THE FREQUENCY OF TROCAR SITE HERNIA AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849403
• Other study ID #: DR.ANIL ERGIN
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: April 2021
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Incisional Hernia
• Obesity, Morbid

Intervention

Procedure:
• CTSP
In all patients Carter Thomasson Suture Passer (CTSP) were used for closing fascial defect peroperatively

Locations

Country	Name	City	State
Turkey	Anil Ergin	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of incisional hernia	Superficial abdominal Ultrasound for the incisional hernia to trocar sites.	2-4 years