Incisional HerniaTSIHiNCT04410744
Incidence and Risk Factors for TSIH
An observational study of Incisional Hernia, run by Hospital de Mataró.
Trial summary
Trocar site incisional hernia (TSIH) is the most frequent complication associated to laparoscopic surgery. Few studies currently describes its real prevalence or risk factors. The aim of this study is to determine the real incidence of TSIH and to identify risk factors in the investigator's series of patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Ultrasonographic examination
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2015to 1 Jan 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All consecutive patients who underwent laparoscopic surgery
Who may be able to join
- Previous laparoscopic surgery
- Age ≥18 years
- Informed consent signed
Who cannot join
- Previous umbilical hernia repair
- Age < 18 years
- Informed consent not signed
- Failure to attend the postoperative appointment
About this study
Official title: Incidence and Risk Factors for Trocar Site Incisional Hernia Detected by Clinical and Ultrasonographic Examination.
Trocar site incisional hernia (TSIH) is the most frequent complication associated to laparoscopic surgery. Few studies currently describes its real prevalence or risk factors. The aim of this study is to determine the real incidence of TSIH and to identify risk factors in the investigator's series of patients.
A cross sectional, prospective study is performed including consecutive patients who underwent a laparoscopic procedure during a four months period. All the patients are assessed both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the incidence of TSIH. A multivariate analysis is performed to identify risk factors.
Read the detailed description
Single-centre cross-sectional study based on prospective clinical and radiological assessment and retrospective risk factor analyses performed at a single hospital.
All consecutive patients who underwent laparoscopic surgery (cholecystectomy, colon resection, adrenalectomy, Nissen fundoplication and appendectomy) during a four months period were included in the study. At least 30 months after hospital discharge, they were invited by telephone to participate in the study. Detailed project information was provided, and those who accepted received an appointment for an outpatient visit and a dynamic ultrasound. Informed consent was obtained from all participants. In all patients, the umbilical trocar wound was closed with an interrupted suture with synthetic braided absorbable 2/0 suture (Novosyn® or Safil®). During the postoperative outpatient visit, clinical and ultrasonographic examinations were performed. To increase study homogeneity, all clinical examinations and ultrasounds were performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively. Sonography was performed with an Applio 500 equipment (Toshiba, Japan) with a 3.5MHz convex probe and a 7MHz linear probe. The ultrasound diagnosis was based on the identification of an abdominal wall defect with intraabdominal tissue protrusion. The main variables of the study were clinical (TSIHc) and ultrasound (TSIHu) diagnosis of incisional hernia. All results and variables were introduced in a previous specifically designed database (File MakerPro 11.0v3 © 1984-2011 FileMaker, Inc.). Data were collected from clinical interviews, physical and radiological examinations and the electronic medical record. Statistical analyses were performed using the SPSS statistical software (IBM SPSS® Statistics).
- Conditions
- Incisional Hernia
- Being tested
- Ultrasonographic examination
- Keywords
- Incisional hernia, Port site, Trocar site, Risk factors, Incidence
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examinationDiagnostic test
Also called Clinical examination
All clinical examinations (physical exam) and ultrasounds are performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical TSIH incidence
Presence / absence palpableTSIH (yes / not)
Measured: 30 seconds
ultrasonographic TSIH incidence
Identification of an abdominal wall defect with intraabdominal tissue protrusion (yes /not) Caudal and cranial diameters of the abdominal wall's defect (cm)
Measured: 1 minute 30 seconds
Secondary outcomes (1)
Risk factors for TSIH
Risk factors for TSIH determination. Information obtained from the electronic medical record
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start2 Jun 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ciscar, Hospital de Mataró
- Investigators
- Ana Ciscar, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410744
- Sponsor's protocol ID
- TSIH INCIDENCE
- Acronym
- TSIHi
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ciscar A, Badia JM, Novell F, Bolivar S, Mans E. Incidence and risk factors for trocar-site incisional hernia detected by clinical and ultrasound examination: a prospective observational study. BMC Surg. 2020 Dec 14;20(1):330. doi: 10.1186/s12893-020-01000-6.
PubMed 33317503
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Trocar Site Incisional Hernia Detected by Clinical and Ultrasonographic Examination.
- ClinicalTrials.gov ID
- NCT04410744
- Acronym / sponsor ID
- TSIHi / TSIH INCIDENCE
- Conditions
- Incisional Hernia
- Keywords
- Incisional hernia, Port site, Trocar site, Risk factors, Incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 1 Jun 2020 (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.
Trocar site incisional hernia (TSIH) is the most frequent complication associated to laparoscopic surgery. Few studies currently describes its real prevalence or risk factors. The aim of this study is to determine the real incidence of TSIH and to identify risk factors in the investigator's series of patients.
A cross sectional, prospective study is performed including consecutive patients who underwent a laparoscopic procedure during a four months period. All the patients are assessed both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the incidence of TSIH. A multivariate analysis is performed to identify risk factors.
Detailed description
Single-centre cross-sectional study based on prospective clinical and radiological assessment and retrospective risk factor analyses performed at a single hospital.
All consecutive patients who underwent laparoscopic surgery (cholecystectomy, colon resection, adrenalectomy, Nissen fundoplication and appendectomy) during a four months period were included in the study. At least 30 months after hospital discharge, they were invited by telephone to participate in the study. Detailed project information was provided, and those who accepted received an appointment for an outpatient visit and a dynamic ultrasound. Informed consent was obtained from all participants. In all patients, the umbilical trocar wound was closed with an interrupted suture with synthetic braided absorbable 2/0 suture (Novosyn® or Safil®). During the postoperative outpatient visit, clinical and ultrasonographic examinations were performed. To increase study homogeneity, all clinical examinations and ultrasounds were performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively. Sonography was performed with an Applio 500 equipment (Toshiba, Japan) with a 3.5MHz convex probe and a 7MHz linear probe. The ultrasound diagnosis was based on the identification of an abdominal wall defect with intraabdominal tissue protrusion. The main variables of the study were clinical (TSIHc) and ultrasound (TSIHu) diagnosis of incisional hernia. All results and variables were introduced in a previous specifically designed database (File MakerPro 11.0v3 © 1984-2011 FileMaker, Inc.). Data were collected from clinical interviews, physical and radiological examinations and the electronic medical record. Statistical analyses were performed using the SPSS statistical software (IBM SPSS® Statistics).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who underwent laparoscopic surgery
Key inclusion criteria (3 listed)
- Previous laparoscopic surgery
- Age ≥18 years
- Informed consent signed
Key exclusion criteria (4 listed)
- Previous umbilical hernia repair
- Age < 18 years
- Informed consent not signed
- Failure to attend the postoperative appointment
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 |
|---|---|---|
| Ultrasonographic examinationAlso: Clinical examinationAll clinical examinations (physical exam) and ultrasounds are performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively. | Diagnostic test | – |
Primary outcome
clinical TSIH incidence
Time frame: 30 seconds
Presence / absence palpableTSIH (yes / not)
ultrasonographic TSIH incidence
Time frame: 1 minute 30 seconds
Identification of an abdominal wall defect with intraabdominal tissue protrusion (yes /not) Caudal and cranial diameters of the abdominal wall's defect (cm)
1 secondary outcome
Risk factors for TSIH
Time frame: 5 minutes
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 4 Jun 2020.
- Derived from this study: PubMed 33317503Ciscar A, Badia JM, Novell F, Bolivar S, Mans E. Incidence and risk factors for trocar-site incisional hernia detected by clinical and ultrasound examination: a prospective observational study. BMC Surg. 2020 Dec 14;20(1):330. doi: 10.1186/s12893-020-01000-6.
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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.
Ana Ciscar principal investigator
Hospital de Mataró
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Hospital de Mataró.
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 3 inclusion and 4 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
clinical TSIH incidence (time frame: 30 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410744, which also lists 1 linked publication.
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 4 Jun 2020.