Inguinal HerniaprofessorNCT04532983
Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation
A study testing fixation of mesh prosthesis and mesh placement without fixation in people with Inguinal Hernia, run by Zagazig University at 1 site in Egypt.
Trial summary
comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- fixation of mesh prosthesis and mesh placement without fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 30 Jun 2020
- 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
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia.
Who cannot join
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study
comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together
Read the detailed description
This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia.
Patient selection; In this study we enrolled patients above
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia. We excluded patients with
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual
Follow up Early postoperative data during the admission were collected, a; pain score (measured by visual analogue scale (VAS), hematoma formation, early recurrence, time needed for ambulation.
Follow up was carried out in outpatients clinics by the attending surgeon after 1 week, 1 month,3 months and 6 months of the operation , the recorded follow up data included wound complications, seroma formation, foreign body sensation and recurrence.
The study was approved by the local ethical committee and institutional review board (IRB) of our university hospitals, all patients signed an informed written consent before participation in this study Preoperative, demographic, operative and postoperative data were collected and properly analyzed using t test, Z test in SPSS 22 program package
- Conditions
- Inguinal Hernia
- Being tested
- fixation of mesh prosthesis, mesh placement without 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.
fixation of mesh prosthesisProcedure or surgery
in the first group mesh was fixed in position with laparoscopic tacks
mesh placement without fixationProcedure or surgery
mesh placement in preperitoneal space without fixation
| Study group | Role | What they receive |
|---|---|---|
| fixation group | Active comparator | ; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), Receives: Procedure: fixation of mesh prosthesis |
| non fixation group | Active comparator | group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation. Receives: Procedure: mesh placement without fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
pain in the first 6 month of surgery measured by visual analogue scale
Measured: 6 month
hernia recurrence
recurrence of inguinal hernia measured by computed tomography of the abdomen
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
- Investigators
- hazem nour, Principal investigator, zag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532983
- Sponsor's protocol ID
- hazem tapp no fix
- Acronym
- professor
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study
- ClinicalTrials.gov ID
- NCT04532983
- Acronym / sponsor ID
- professor / hazem tapp no fix
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 31 Aug 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.
comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together
Detailed description
This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia.
Patient selection; In this study we enrolled patients above
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia. We excluded patients with
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual
Follow up Early postoperative data during the admission were collected, a; pain score (measured by visual analogue scale (VAS), hematoma formation, early recurrence, time needed for ambulation.
Follow up was carried out in outpatients clinics by the attending surgeon after 1 week, 1 month,3 months and 6 months of the operation , the recorded follow up data included wound complications, seroma formation, foreign body sensation and recurrence.
The study was approved by the local ethical committee and institutional review board (IRB) of our university hospitals, all patients signed an informed written consent before participation in this study Preoperative, demographic, operative and postoperative data were collected and properly analyzed using t test, Z test in SPSS 22 program package
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- ; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
| Arm | Type | Receives |
|---|---|---|
| fixation group | Active comparator | Procedure: fixation of mesh prosthesis; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), |
| non fixation group | Active comparator | Procedure: mesh placement without fixationgroup B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old suffering unilateral,
- non -recurrent,
- un-complicated inguinal hernia.
Key exclusion criteria (5 listed)
- previous abdominal or pelvic surgery,
- unfit with laparoscopic surgery,
- those with ascites,
- abdominal malignancy
- on chemotherapy and immune-compromised patients.
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 |
|---|---|---|
| fixation of mesh prosthesisin the first group mesh was fixed in position with laparoscopic tacks | Procedure or surgery | fixation group |
| mesh placement without fixationmesh placement in preperitoneal space without fixation | Procedure or surgery | non fixation group |
Primary outcome
postoperative pain
Time frame: 6 month
pain in the first 6 month of surgery measured by visual analogue scale
hernia recurrence
Time frame: 1 year
recurrence of inguinal hernia measured by computed tomography of the abdomen
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 31 Aug 2020.
- Individual participant dataSharing planned: No
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Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
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Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
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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.
hazem nour principal investigator
zag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixation of mesh prosthesis and mesh placement without fixation in people with Inguinal Hernia, run by Zagazig 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 5 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 31 Aug 2020. 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?
postoperative pain (time frame: 6 month). 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 31 Aug 2020.