NCT04849403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

April 10, 2021

Last Update Submit

April 13, 2021

Conditions

Keywords

Laparoscopic Sleeve GastrectomyMorbid obesityTrocar site herniaCarter Thomasson Suture Passer

Outcome Measures

Primary Outcomes (1)

  • incidence of incisional hernia

    Superficial abdominal Ultrasound for the incisional hernia to trocar sites.

    2-4 years

Study Arms (1)

The group USG was applied

OTHER

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.

Procedure: CTSP

Interventions

CTSPPROCEDURE

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

The group USG was applied

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients above 18 years old.
  • The patient who went Laparoscopic Sleeve Gastrectomy (LSG) procedure for morbid obesity.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anıl Ergin

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, MorbidIncisional Hernia

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHerniaPathological Conditions, AnatomicalPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Anil Ergin

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 19, 2021

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations