Incisional HerniaPhase 3NCT04347642
Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
A Phase 3 study testing Umbilical port placement and Paraumbilical port placement in people with Incisional Hernia, run by Hospital General Universitario Elche at 2 sites in 2 countries.
Trial summary
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy. Patients will be randomized into 2 groups: G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port G2: 12 mm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Umbilical port placement and Paraumbilical port placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Jul 2020to 15 Sep 2021
- 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
- Elective laparoscopic cholecystectomy
- Acceptance to participate in the study and sign of informed consent form
Who cannot join
- A gallstone larger than 10mm observed at preoperative ultrasonography
- Coexistence of umbilical hernia or previous umbilical hernioplasty
- Previous laparotomy involving the umbilical region
- Emergency surgery
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mexico1 site, 1 recruiting
- Recruiting
Gilberto Gonzalez
Guadalajara
Gilberto Gonzalez, +52 33 3848 2100
Spain1 site, 1 recruiting
- Recruiting
Jaime Ruiz-Tovar
Madrid, Introducir Provincia O Estado, 28002
Jaime Ruiz-Tovar, +34630534808, jruiztovar@gmail.com
About this study
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port
- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
Read the detailed description
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.
- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
- Conditions
- Incisional Hernia
- Being tested
- Umbilical port placement, Paraumbilical port placement
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical port placementProcedure or surgery
The port will be inserted in the midline at the level of the umbilicus.
Paraumbilical port placementProcedure or surgery
The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical port | Active comparator | A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers. Receives: Procedure: Umbilical port placement |
| Paraumbilical port | Experimental | A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle. Receives: Procedure: Paraumbilical port placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia at the level of the trocar insertion
The incisional hernia at the level of the umbilical or paraumbilial trocar insertion will be assessed by physical examination, or with ultrasonography in case of doubts.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start7 Jul 2020
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Gilberto Gonzalez, Study chair, Centro PDH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347642
- Sponsor's protocol ID
- Garcilaso 2020/1
- Status last verified
- Jul 2020
- First submitted
- 12 Apr 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04347642
- Acronym / sponsor ID
- Garcilaso 2020/1
- Conditions
- Incisional Hernia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 15 Apr 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.
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port
- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
Detailed description
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.
- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical port | Active comparator | Procedure: Umbilical port placementA Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers. |
| Paraumbilical port | Experimental | Procedure: Paraumbilical port placementA bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective laparoscopic cholecystectomy
- Acceptance to participate in the study and sign of informed consent form
Key exclusion criteria (4 listed)
- A gallstone larger than 10mm observed at preoperative ultrasonography
- Coexistence of umbilical hernia or previous umbilical hernioplasty
- Previous laparotomy involving the umbilical region
- Emergency surgery
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 |
|---|---|---|
| Umbilical port placementThe port will be inserted in the midline at the level of the umbilicus. | Procedure or surgery | Umbilical port |
| Paraumbilical port placementThe port will be inserted 3-4cm laterally to the midline at the level of the umbilicus. | Procedure or surgery | Paraumbilical port |
Primary outcome
Incisional hernia at the level of the trocar insertion
Time frame: 12 months after surgery
The incisional hernia at the level of the umbilical or paraumbilial trocar insertion will be assessed by physical examination, or with ultrasonography in case of doubts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Gilberto Gonzalez study chair
Centro PDH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Umbilical port placement and Paraumbilical port placement in people with Incisional Hernia, run by Hospital General Universitario Elche at 2 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico, 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?
Contact Jaime Ruiz-Tovar (+34630534808, jruiztovar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia at the level of the trocar insertion (time frame: 12 months after surgery). 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 Jul 2020.