Inguinal HerniaNCT06679504
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
An observational study of Inguinal Hernia, run by Suez Canal University at 1 site in Egypt.
Trial summary
The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Fibrin glue fixation and Tack fixation
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 30 Jun 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients complain of uncomplicated inguinal hernia who are scheduled for laparoscopic TEP hernioplasty
Who may be able to join
- Age group of 18-60 years.
- All types of inguinal hernias.
- Didn't undergo pervious hernia repair surgery.
Who cannot join
- Patients who are unfit for general anesthesia or with American Society of Anesthesiologists (ASA) grade 3 and above.
- Presence of other groin or abdominal hernias.
- Patients with complicated hernias such as irreducibility, obstruction, and incarceration.
- Patients with obesity or morbid obesity BMI >= 35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.
Read the detailed description
A wide variety of mesh fixation techniques are available for laparoscopic hernia repair. These can be broadly divided into mechanical and nonmechanical methods. Mechanical methods include sutures and tissue penetrating fixation devices like tackers. Nonmechanical techniques include self-gripping meshes and tissue adhesives (glues).
Mechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. On the other hand, nonmechanical methods do not have these disadvantages.
Furthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. To the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. Therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.
- Conditions
- Inguinal Hernia
- Being tested
- Fibrin glue fixation, Tack fixation
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin glue fixationProcedure or surgery
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation
Tack fixationProcedure or surgery
Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation
| Study group | Role | What they receive |
|---|---|---|
| Fibrin glue group | Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Receives: Procedure: Fibrin glue fixation | |
| Tack fixation group | Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation Receives: Procedure: Tack fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment
The postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire. The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The higher scores mean better quality of life..
Measured: 7 days, 15 days, 1 month, 2 months, and 3 months.
Secondary outcomes (1)
Postoperative pain assessment
VAS; visual analogue scale. for pain assessment. the score ranges from 1-10... higher score denotes more pain.
Measured: 7 days, 15 days, 1 month, 2 months, and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jul 2022
- Primary completion15 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ghareeb, Suez Canal University
- Investigators
- Sameh Tolba, PhD, MD, Study director, Suez canal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679504
- Sponsor's protocol ID
- #4846/2022
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation
- ClinicalTrials.gov ID
- NCT06679504
- Acronym / sponsor ID
- #4846/2022
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Nov 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.
The quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.
Detailed description
A wide variety of mesh fixation techniques are available for laparoscopic hernia repair. These can be broadly divided into mechanical and nonmechanical methods. Mechanical methods include sutures and tissue penetrating fixation devices like tackers. Nonmechanical techniques include self-gripping meshes and tissue adhesives (glues).
Mechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. On the other hand, nonmechanical methods do not have these disadvantages.
Furthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. As many as 10% of the patients report increased pain following surgery. Such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. To the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. Therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin glue group | – | Procedure: Fibrin glue fixationLaparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue |
| Tack fixation group | – | Procedure: Tack fixationLaparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue Versus Tack Mesh Fixation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients complain of uncomplicated inguinal hernia who are scheduled for laparoscopic TEP hernioplasty
Key inclusion criteria (3 listed)
- Age group of 18-60 years.
- All types of inguinal hernias.
- Didn't undergo pervious hernia repair surgery.
Key exclusion criteria (4 listed)
- Patients who are unfit for general anesthesia or with American Society of Anesthesiologists (ASA) grade 3 and above.
- Presence of other groin or abdominal hernias.
- Patients with complicated hernias such as irreducibility, obstruction, and incarceration.
- Patients with obesity or morbid obesity BMI >= 35.
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 |
|---|---|---|
| Fibrin glue fixationLaparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Fibrin Glue fixation | Procedure or surgery | Fibrin glue group |
| Tack fixationLaparoscopic Totally Extraperitoneal Inguinal Hernia Repair With Tack Mesh Fixation | Procedure or surgery | Tack fixation group |
Primary outcome
Quality of life assessment
Time frame: 7 days, 15 days, 1 month, 2 months, and 3 months.
The postoperative quality of life has been compared between both groups using SF-36 scoring questionnaire. The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). The higher scores mean better quality of life..
1 secondary outcome
Postoperative pain assessment
Time frame: 7 days, 15 days, 1 month, 2 months, and 3 months.
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 12 Nov 2024.
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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.
Sameh Tolba, PhD, MD study director
Suez canal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Suez Canal University at 1 site in Egypt.
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 12 Nov 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 Egypt. 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?
Quality of life assessment (time frame: 7 days, 15 days, 1 month, 2 months, and 3 months.). 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 12 Nov 2024.