Obesity, MorbidNCT04849403
TROCAR SITE HERNIA AFTER LSG
A study testing CTSP in people with Obesity, Morbid and Hernia Incisional, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Obesity, Morbid, Hernia Incisional
- What is being tested?
- CTSP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients above 18 years old.
- The patient who went Laparoscopic Sleeve Gastrectomy (LSG) procedure for morbid obesity.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE FREQUENCY OF TROCAR SITE HERNIA AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY
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.
Read the 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).
- Conditions
- Obesity, Morbid, Hernia Incisional
- Being tested
- CTSP
- Keywords
- Laparoscopic Sleeve Gastrectomy, Morbid obesity, Trocar site hernia, Carter Thomasson Suture Passer
- Medical subject headings
- Obesity, Morbid, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTSPProcedure or surgery
In all patients Carter Thomasson Suture Passer (CTSP) were used for closing fascial defect peroperatively
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CTSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of incisional hernia
Superficial abdominal Ultrasound for the incisional hernia to trocar sites.
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jan 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849403
- Sponsor's protocol ID
- DR.ANIL ERGIN
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE FREQUENCY OF TROCAR SITE HERNIA AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY
- ClinicalTrials.gov ID
- NCT04849403
- Acronym / sponsor ID
- DR.ANIL ERGIN
- Conditions
- Obesity, Morbid, Hernia Incisional
- Keywords
- Laparoscopic Sleeve Gastrectomy, Morbid obesity, Trocar site hernia, Carter Thomasson Suture Passer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| The group USG was applied | Other | Procedure: CTSPUSG 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. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patients above 18 years old.
- The patient who went Laparoscopic Sleeve Gastrectomy (LSG) procedure for morbid obesity.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTSPIn all patients Carter Thomasson Suture Passer (CTSP) were used for closing fascial defect peroperatively | Procedure or surgery | The group USG was applied |
Primary outcome
incidence of incisional hernia
Time frame: 2-4 years
Superficial abdominal Ultrasound for the incisional hernia to trocar sites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTSP in people with Obesity, Morbid and Hernia Incisional, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of incisional hernia (time frame: 2-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.