Incisional Hernia of Anterior Abdominal WallPhase 3INDURATENCT06251583
Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.
A Phase 3 study testing duramesh suture in people with Incisional Hernia of Anterior Abdominal Wall and Dehiscence Wound, run by Miguel A ngel Garci-a Urena at 1 site in Spain.
Trial summary
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Anterior Abdominal Wall, Dehiscence Wound, Wound Infection
- What is being tested?
- duramesh suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- 22 Mar 2023to 30 Jun 2025
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (at least 18 year-old patients)
- Umbilical trocar incision > 10 mm
- Any of the following risk factors: BMI > 27, Absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease.
Who cannot join
- Umbilical trocar incision < 10 mm
- Umbilical hernia > 10 mm
- Hernia surgery or incisional hernia at the trocar site
- Conversion to laparotomy
- Pregnancy
- Ascites or cirrhosis
Show all 11Show fewer
- Clasification of the American Anestesiology Classification IV o V.
- Inadequate follow-up
- Patients included in any other trial
- Patients with life expectancy < 12 months
- Patients with any kind of sensibility to Duramesh
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Miguel Ángel García Ureña
Madrid, 28022
Ana Sánchez Gollarte, MD, 651690526, asgollarte@gmail.com
Ana Sánchez Gollarte, MD
About this study
Official title: Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs.
The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias.
INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
- Being tested
- duramesh suture
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duramesh sutureDevice
Duramesh-suture will be used for trocar closure in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group or Duramesh group | Experimental | Umbilical trocar closure using Suture-mesh (Duramesh suture). Receives: Device: duramesh suture |
| Control group or poli(4)hidroxibutirate group | Active comparator | Umbilical trocar closure using conventional monofilament suture. Receives: Device: duramesh suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the umbilical trocar site hernia in each group
Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group
Measured: 12 monts
Secondary outcomes (5)
Infectious complications of the wound
Evaluation of the infectious complications related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
Measured: 12 months
Seroma and hematoma
Evaluation of the seroma and hematoma related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
Measured: 12 months
Intraabdominal events
Evaluation of intraabdominal events (fluid collections, bleeding, peritonitis...) and compare the incidence in each group.
Measured: 12 months
Skin dehiscence and/or necrosis
Evaluate the incidence of skin complications in each group.
Measured: 12 months
Early aponeurotic failure (evisceration)
Evaluation of early aponeurotic failure after laparoscopic procuderes and compare the incidence between the two different groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start22 Mar 2023
- Primary completion22 Mar 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Anterior Abdominal WallStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miguel A ngel Garci-a Urena
- Sponsor type
- University, hospital or other
- Collaborators
- Ana Sánchez Gollarte, Álvaro Robin Valle de Lersundi, Arturo Cruz Cidoncha, Almudena Moreno Elola-Olaso, Armando Galván Pérez, Ana María Minaya Bravo, Enrique González González, Carlos Guijarro Moreno, Asunción Aguilera Velardo, Patricia López Quindos, Clara María Martínez Moreno, Marina Pérez-Flecha González, Victor Vaello Jodra
- Responsible party
- Sponsor-investigator, Miguel A ngel Garci-a Urena, Henares University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251583
- Sponsor's protocol ID
- INDURATE
- Acronym
- INDURATE
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
- ClinicalTrials.gov ID
- NCT06251583
- Acronym / sponsor ID
- INDURATE / INDURATE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Miguel A ngel Garci-a UrenaUniversity, hospital or other
- Collaborators
- Ana Sánchez Gollarte, Álvaro Robin Valle de Lersundi, Arturo Cruz Cidoncha, Almudena Moreno Elola-Olaso, Armando Galván Pérez, Ana María Minaya Bravo, Enrique González González, Carlos Guijarro Moreno, Asunción Aguilera Velardo, Patricia López Quindos, Clara María Martínez Moreno, Marina Pérez-Flecha González, Victor Vaello Jodra
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 22 Mar 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Feb 2024 (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.
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs.
The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias.
INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group or Duramesh group | Experimental | Device: duramesh sutureUmbilical trocar closure using Suture-mesh (Duramesh suture). |
| Control group or poli(4)hidroxibutirate group | Active comparator | Device: duramesh sutureUmbilical trocar closure using conventional monofilament suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (at least 18 year-old patients)
- Umbilical trocar incision > 10 mm
- Any of the following risk factors: BMI > 27, Absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease.
Key exclusion criteria (11 listed)
- Umbilical trocar incision < 10 mm
- Umbilical hernia > 10 mm
- Hernia surgery or incisional hernia at the trocar site
- Conversion to laparotomy
- Pregnancy
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 |
|---|---|---|
| duramesh sutureDuramesh-suture will be used for trocar closure in the experimental group | Device | Control group or poli(4)hidroxibutirate group, Experimental group or Duramesh group |
Primary outcome
Incidence of the umbilical trocar site hernia in each group
Time frame: 12 monts
Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group
5 secondary outcomes
Infectious complications of the wound
Time frame: 12 months
Seroma and hematoma
Time frame: 12 months
Intraabdominal events
Time frame: 12 months
Skin dehiscence and/or necrosis
Time frame: 12 months
Early aponeurotic failure (evisceration)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing duramesh suture in people with Incisional Hernia of Anterior Abdominal Wall and Dehiscence Wound, run by Miguel A ngel Garci-a Urena at 1 site in Spain.
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 11 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the umbilical trocar site hernia in each group (time frame: 12 monts). 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 9 Feb 2024.