Incisional HerniaHOTNCT04254237
Trocar Site Hernia After Laparoscopic Cholecystectomy, Supra Versus Infraumbilical Incision for Umbilical Trocar Entry
A study testing Infraumbilical Hasson trocar incision and Supraumbilical Hasson trocar incision in people with Incisional Hernia and Cholecystectomy, Laparoscopic, run by Complejo Hospitalario La Mancha Centro at 3 sites in Spain.
Trial summary
Trocar site hernia is a specific complication of laparoscopic surgery. The increasingly frequent use of the laparoscopic approach has resulted in an increase in the number of hernias, mainly at the umbilical area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Cholecystectomy, Laparoscopic
- What is being tested?
- Infraumbilical Hasson trocar incision and Supraumbilical Hasson trocar incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesSpain
- Study dates
- 6 Feb 2020to 30 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Ability to understand the trial information.
- Patients with symptomatic gallstones or polyps scheduled for laparoscopic cholecystectomy.
- Elective surgery.
- One year potential follow-up.
- Patients that experience one or more of the following Trocar Site Hernia risk factors:
Show all 11Show fewer
- Over 60 years old.
- Obesity, defined as Body Mass Index (BMI) > 30 Kg/m2.
- Diabetes mellitus (DM).
- Bronchopathy: A diagnosed Chronic Obstructive Pulmonary Disease (COPD) or smokers of more than 25 cigarette packages/year.
- Accept to participate in the study and sign the informed consent.
Who cannot join
- Contraindication to conduct a laparoscopic cholecystectomy.
- Patients with previous open supramesocolic surgery.
- Patients with previous surgery that affects the umbilical region.
- Patients with umbilical hernia or history of umbilical hernia surgical correction.
- A greater than 30 cm xifo-umbilical distance.
- Extreme obesity (Body Mass Index > 50 kg/m2).
- Cancer patients or in immunosuppressive therapy.
- Connective tissue disease.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
La Mancha Centro General Hospital
Alcázar de San Juan, Ciudad Real, 13600
Tomelloso General Hospital
Tomelloso, Ciudad Real, 13700
Valdepeñas General Hospital
Valdepeñas, Ciudad Real, 13300
About this study
Official title: Trocar Site Hernia After Laparoscopic Cholecystectomy: Randomized Clinical Trial Comparing Supra Versus Infraumbilical Incision for Umbilical Trocar Entry
Trocar site hernia is a specific complication of laparoscopic surgery. The increasingly frequent use of the laparoscopic approach has resulted in an increase in the number of hernias, mainly at the umbilical area. The appearance of a trocar site hernia can cause complications in the short and long term to the patient who may end up needing a reoperation.
In this study we want to compare the supraumbilical versus the infraumbilical location of the laparoscopy entry trocar, in terms of incisional hernia incidence.
Read the detailed description
Trocar site hernias have been considered as an underestimated problem by some surgeons. It's incidence varies in the literature between studies, which may be related to an insufficient diagnosis due to poor clinical manifestation and / or the lack of long-term follow-up of patients in some studies.
There are many risk factors that have been related to the trocar site hernia development. On one side, the patient clinical factors as the age, presence of obesity, diabetes mellitus or the smoking habits. On the other side, some risk factors related to the surgical technique have been described, as the entry technique, the size and the locations of the trocars, the fascial closure, the duration of the surgery or the infection of the surgical wound.
Regarding the location of the trocars, it seems that the middle line has more risk of incisional hernia than the lateral areas in the abdomen. However, the trocar locations out of the middle line is not always possible, especially in certain surgeries as the laparoscopic cholecystectomy where it can be necessary an expansion of the incision for removing the specimen. In the concrete case of laparoscopic cholecystectomy, the belly is usually the most popular region for placing the first trocar. However, there is not much evidence about the influence of the most popular locations of the umbilical trocar incision (supra or infraumbilical) in the development of incisional hernias.
In the middle line, the infraumbilical region presents a great ability to adapt to pressure changes, as it physiologically occurs during the pregnancy. On the other side, while the primary hernias in the supraumbilical and umbilical region are common, these are not produced in the infraumbilical region. Besides, in anatomical studies of the linea alba, a higher thickness of the fibres in the infraumbilical region has been observed, along with a different spatial arrangement, predominating the transverse fibres in the infraumbilical region and the oblique ones in the supraumbilical region. Therefore, we hypothesize whether the infraumbilical location of the trocar in the midline, theoretically a more protected region, can reduce the incidence of trocar site hernia in our patients.
The aim of this study is to compare the incidence of the Hasson trocar site hernia between the supra and infraumbilical locations a year after surgery, in high risk patients for trocar site hernia subjected to elective laparoscopic cholecystectomy.
- Conditions
- Incisional Hernia, Cholecystectomy, Laparoscopic
- Being tested
- Infraumbilical Hasson trocar incision, Supraumbilical Hasson trocar incision
- Keywords
- Trocar site hernia, Laparoscopy, Laparoscopic cholecystectomy, Minimally invasive surgery
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraumbilical Hasson trocar incisionProcedure or surgery
Infraumbilical Hasson trocar incision
Supraumbilical Hasson trocar incisionProcedure or surgery
Supraumbilical Hasson trocar incision
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Infraumbilical Hasson trocar incision. Receives: Procedure: Infraumbilical Hasson trocar incision |
| Control group | Sham comparator | Supraumbilical Hasson trocar incision. Receives: Procedure: Supraumbilical Hasson trocar incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trocar site hernia
Number of patients presenting a trocar site hernia, at the periumbilical incision, one year after laparoscopic cholecystectomy.
Measured: One year
Secondary outcomes (9)
Umbilical wound complications different from Trocar Site Hernia
Infection, seroma or ecchymosis at the umbilical wound
Measured: 24 hours, 7 days, 30 days, 6 months and 1 year.
Non-umbilical wounds complications
Hernia, infection, seroma, ecchymosis or evisceration at non-umbilical wounds.
Measured: 24 hours, 7 days, 30 days, 6 months and 1 year.
Other complications
Other complications not related to the surgical wound
Measured: 24 hours, 7 days, 30 days, 6 months and 1 year.
Surgical time
Measured in minutes from the first incision until the complete closure of the last surgical wound
Measured: Day 0
Conversion
Conversion rate to open surgery (yes/no).
Measured: Day 0
Hospital stay
Measured in hours from the surgery to the patient discharge.
Measured: Day 0
Postoperative pain
Measured using the Visual Analogue Scale (VAS), with a punctuation between 0 (no pain) and 10 (the worst conceivable pain).
Measured: 24 hours and 7 days after surgery.
Perceived Quality of Life
Measured using the SF-36 questionnaire,
Measured: baseline, one month and a year after surgery.
Aesthetic result
Measured using the Visual Analogue Scale, with a punctuation between 0 (not at all satisfied) and 10 (maximum satisfaction).
Measured: Six months and a year of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start6 Feb 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario La Mancha Centro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Morandeira Rivas, MD PhD, Complejo Hospitalario La Mancha Centro
- Investigators
- Antonio Morandeira-Rivas, MD PhD, Principal investigator, La Mancha Centro General HospitalCarlos Moreno Sanz, MD PhD FACS, Study chair, La Mancha Centro General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254237
- Sponsor's protocol ID
- 99-B
- Acronym
- HOT
- Status last verified
- Sep 2023
- First submitted
- 1 Feb 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trocar Site Hernia After Laparoscopic Cholecystectomy: Randomized Clinical Trial Comparing Supra Versus Infraumbilical Incision for Umbilical Trocar Entry
- ClinicalTrials.gov ID
- NCT04254237
- Acronym / sponsor ID
- HOT / 99-B
- Conditions
- Incisional Hernia, Cholecystectomy, Laparoscopic
- Keywords
- Trocar site hernia, Laparoscopy, Laparoscopic cholecystectomy, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Complejo Hospitalario La Mancha CentroUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 5 Feb 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 hernia is a specific complication of laparoscopic surgery. The increasingly frequent use of the laparoscopic approach has resulted in an increase in the number of hernias, mainly at the umbilical area. The appearance of a trocar site hernia can cause complications in the short and long term to the patient who may end up needing a reoperation.
In this study we want to compare the supraumbilical versus the infraumbilical location of the laparoscopy entry trocar, in terms of incisional hernia incidence.
Detailed description
Trocar site hernias have been considered as an underestimated problem by some surgeons. It's incidence varies in the literature between studies, which may be related to an insufficient diagnosis due to poor clinical manifestation and / or the lack of long-term follow-up of patients in some studies.
There are many risk factors that have been related to the trocar site hernia development. On one side, the patient clinical factors as the age, presence of obesity, diabetes mellitus or the smoking habits. On the other side, some risk factors related to the surgical technique have been described, as the entry technique, the size and the locations of the trocars, the fascial closure, the duration of the surgery or the infection of the surgical wound.
Regarding the location of the trocars, it seems that the middle line has more risk of incisional hernia than the lateral areas in the abdomen. However, the trocar locations out of the middle line is not always possible, especially in certain surgeries as the laparoscopic cholecystectomy where it can be necessary an expansion of the incision for removing the specimen. In the concrete case of laparoscopic cholecystectomy, the belly is usually the most popular region for placing the first trocar. However, there is not much evidence about the influence of the most popular locations of the umbilical trocar incision (supra or infraumbilical) in the development of incisional hernias.
In the middle line, the infraumbilical region presents a great ability to adapt to pressure changes, as it physiologically occurs during the pregnancy. On the other side, while the primary hernias in the supraumbilical and umbilical region are common, these are not produced in the infraumbilical region. Besides, in anatomical studies of the linea alba, a higher thickness of the fibres in the infraumbilical region has been observed, along with a different spatial arrangement, predominating the transverse fibres in the infraumbilical region and the oblique ones in the supraumbilical region. Therefore, we hypothesize whether the infraumbilical location of the trocar in the midline, theoretically a more protected region, can reduce the incidence of trocar site hernia in our patients.
The aim of this study is to compare the incidence of the Hasson trocar site hernia between the supra and infraumbilical locations a year after surgery, in high risk patients for trocar site hernia subjected to elective laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Infraumbilical Hasson trocar incisionInfraumbilical Hasson trocar incision. |
| Control group | Sham comparator | Procedure: Supraumbilical Hasson trocar incisionSupraumbilical Hasson trocar incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Over 18 years old.
- Ability to understand the trial information.
- Patients with symptomatic gallstones or polyps scheduled for laparoscopic cholecystectomy.
- Elective surgery.
- One year potential follow-up.
Key exclusion criteria (8 listed)
- Contraindication to conduct a laparoscopic cholecystectomy.
- Patients with previous open supramesocolic surgery.
- Patients with previous surgery that affects the umbilical region.
- Patients with umbilical hernia or history of umbilical hernia surgical correction.
- A greater than 30 cm xifo-umbilical distance.
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 |
|---|---|---|
| Infraumbilical Hasson trocar incisionInfraumbilical Hasson trocar incision | Procedure or surgery | Intervention group |
| Supraumbilical Hasson trocar incisionSupraumbilical Hasson trocar incision | Procedure or surgery | Control group |
Primary outcome
Trocar site hernia
Time frame: One year
Number of patients presenting a trocar site hernia, at the periumbilical incision, one year after laparoscopic cholecystectomy.
9 secondary outcomes
Umbilical wound complications different from Trocar Site Hernia
Time frame: 24 hours, 7 days, 30 days, 6 months and 1 year.
Non-umbilical wounds complications
Time frame: 24 hours, 7 days, 30 days, 6 months and 1 year.
Other complications
Time frame: 24 hours, 7 days, 30 days, 6 months and 1 year.
Surgical time
Time frame: Day 0
Conversion
Time frame: Day 0
Hospital stay
Time frame: Day 0
Postoperative pain
Time frame: 24 hours and 7 days after surgery.
Perceived Quality of Life
Time frame: baseline, one month and a year after surgery.
Aesthetic result
Time frame: Six months and a year of the surgery.
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 6 Sep 2023.
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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.
Antonio Morandeira-Rivas, MD PhD principal investigator
La Mancha Centro General Hospital
Carlos Moreno Sanz, MD PhD FACS study chair
La Mancha Centro General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraumbilical Hasson trocar incision and Supraumbilical Hasson trocar incision in people with Incisional Hernia and Cholecystectomy, Laparoscopic, run by Complejo Hospitalario La Mancha Centro at 3 sites 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 11 inclusion and 8 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Trocar site hernia (time frame: One year). 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 6 Sep 2023.