Inguinal Hernia UnilateralNCT05574751
Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
A study testing Titanium tacker and Polypropylene 0 in people with Inguinal Hernia Unilateral, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Inguinal Hernia Unilateral
- What is being tested?
- Titanium tacker and Polypropylene 0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Nov 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Patients with body mass index (BMI) of 25 to 35 kg/m²
- Unilateral inguinal hernia
Who cannot join
- Age < 21 years
- ASA physical status > II
- Patients with body mass index (BMI) > 35 kg/m²
- Pregnant women
- Bilateral inguinal hernia
- Large inguinoscrotal hernia
Show all 17Show fewer
- Incarcerated hernia
- Recurrent hernia
- Strangulated hernia
- Prostatic diseases
- History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
- Dysrhythmia
- Hypertension
- Ischemic heart disease
- Hyperthyroidism
- Liver or Renal impairment
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation.
Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use.
Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.
- Conditions
- Inguinal Hernia Unilateral
- Being tested
- Titanium tacker, Polypropylene 0
- Keywords
- Inguinal hernia, Mesh fixation, Titanium tacker
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium tackerOther
Mesh fixation with Titanium tacker
Polypropylene 0Other
Mesh was sutured and fixed with polypropylene 0
| Study group | Role | What they receive |
|---|---|---|
| Titanium tacker group (n=30) | Active comparator | Group A Receives: Other: Titanium tacker |
| Polypropylene group (n=30) | Active comparator | Group B Receives: Other: Polypropylene 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Measured: 7 days after the end of the operation
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Measured: 7 days after the end of the operation
Secondary outcomes (4)
Mean and Standard deviation of Operative duration (minutes) (mean±SD)
Time from skin incision till skin closure
Measured: 2 minutes after the end of the operation
Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)
Time from hospital admission till discharge
Measured: 24 hours after the end of the operation
Number of participants and Rate of Intraoperative complications
Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury.
Measured: 2 minutes after the end of the operation
Number of participants and Rate of Postoperative complications
Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence.
Measured: 1 year after the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Sep 2018
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia UnilateralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574751
- Sponsor's protocol ID
- DTH: 22002
- Status last verified
- Jan 2022
- First submitted
- 7 Oct 2022
- Last updated
- 22 Nov 2022
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
- ClinicalTrials.gov ID
- NCT05574751
- Acronym / sponsor ID
- DTH: 22002
- Conditions
- Inguinal Hernia Unilateral
- Keywords
- Inguinal hernia, Mesh fixation, Titanium tacker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 12 Oct 2022 (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.
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation.
Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use.
Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium tacker group (n=30) | Active comparator | Other: Titanium tackerGroup A |
| Polypropylene group (n=30) | Active comparator | Other: Polypropylene 0Group B |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 21 years
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Patients with body mass index (BMI) of 25 to 35 kg/m²
- Unilateral inguinal hernia
Key exclusion criteria (17 listed)
- Age < 21 years
- ASA physical status > II
- Patients with body mass index (BMI) > 35 kg/m²
- Pregnant women
- Bilateral inguinal hernia
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 |
|---|---|---|
| Titanium tackerMesh fixation with Titanium tacker | Other | Titanium tacker group (n=30) |
| Polypropylene 0Mesh was sutured and fixed with polypropylene 0 | Other | Polypropylene group (n=30) |
Primary outcome
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
Time frame: 7 days after the end of the operation
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Time frame: 7 days after the end of the operation
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
4 secondary outcomes
Mean and Standard deviation of Operative duration (minutes) (mean±SD)
Time frame: 2 minutes after the end of the operation
Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)
Time frame: 24 hours after the end of the operation
Number of participants and Rate of Intraoperative complications
Time frame: 2 minutes after the end of the operation
Number of participants and Rate of Postoperative complications
Time frame: 1 year after the end of the operation
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 22 Nov 2022.
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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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium tacker and Polypropylene 0 in people with Inguinal Hernia Unilateral, run by Damanhour Teaching Hospital 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 4 inclusion and 17 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 22 Nov 2022. 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?
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] (time frame: 7 days after the end of the operation). 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?
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 22 Nov 2022.