Recurrent Inguinal HerniaNCT06050538
Laparscopic Hernioplasty in Recurrent Inguinal Hernia
A study testing Transabdominal preperitoneal (TAPP) using polyprolene mesh and Total extraperitoneal (TEP) hernioplasty using polyprolene mesh in people with Recurrent Inguinal Hernia, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Inguinal Hernia
- What is being tested?
- Transabdominal preperitoneal (TAPP) using polyprolene mesh and Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Aug 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
- Patients between 18 and 70 years old
- Fit for anesthesia.
- Agree to participate in the study
- Both genders were included.
Who cannot join
- Unfitness for general anesthesia and operation.
- Age < 18 years or >70 years.
- Complicated hernias (acute irreducible, obstruction or strangulation).
- The presence of mental or psychological disorders.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia
The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.
Read the detailed description
The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.
- Conditions
- Recurrent Inguinal Hernia
- Being tested
- Transabdominal preperitoneal (TAPP) using polyprolene mesh, Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
- Keywords
- TAPP, TEP, Laparoscopic Inguinal Hernia, Recurrent hernia
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal preperitoneal (TAPP) using polyprolene meshProcedure or surgery
Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh
Total extraperitoneal (TEP) hernioplasty using polyprolene meshProcedure or surgery
Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal preperitoneal (TAPP) | Active comparator | patients with recurrent inguinal hernia who had Transabdominal preperitoneal (TAPP) approach Receives: Procedure: Transabdominal preperitoneal (TAPP) using polyprolene mesh |
| Total extraperitoneal (TEP) approach | Active comparator | patients with recurrent inguinal hernia who had Total extraperitoneal (TEP) approach Receives: Procedure: Total extraperitoneal (TEP) hernioplasty using polyprolene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.
Measured: 6 months
Secondary outcomes (2)
operative time
operative time by minutes was reported to get mean and standard deviation
Measured: 6 months
complications
complications will be described as number and percentages in each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Feb 2021
- Primary completion1 Feb 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- patients diagnosed with recurrent inguinal hernia. The study population were randomly distributed into 2 groups by computer generating program; group (1) included patients who had Transabdominal preperitoneal (TAPP) approach while group (2) included patients who had Total extraperitoneal (TEP) approach.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Hisham, Mansoura University
- Investigators
- Islam Hisham, MSc, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050538
- Sponsor's protocol ID
- MD.21.03.439
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 22 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia
- ClinicalTrials.gov ID
- NCT06050538
- Acronym / sponsor ID
- MD.21.03.439
- Conditions
- Recurrent Inguinal Hernia
- Keywords
- TAPP, TEP, Laparoscopic Inguinal Hernia, Recurrent hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 22 Sep 2023 (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 purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.
Detailed description
The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- patients diagnosed with recurrent inguinal hernia. The study population were randomly distributed into 2 groups by computer generating program; group (1) included patients who had Transabdominal preperitoneal (TAPP) approach while group (2) included patients who had Total extraperitoneal (TEP) approach.
| Arm | Type | Receives |
|---|---|---|
| Transabdominal preperitoneal (TAPP) | Active comparator | Procedure: Transabdominal preperitoneal (TAPP) using polyprolene meshpatients with recurrent inguinal hernia who had Transabdominal preperitoneal (TAPP) approach |
| Total extraperitoneal (TEP) approach | Active comparator | Procedure: Total extraperitoneal (TEP) hernioplasty using polyprolene meshpatients with recurrent inguinal hernia who had Total extraperitoneal (TEP) approach |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
- Patients between 18 and 70 years old
- Fit for anesthesia.
- Agree to participate in the study
- Both genders were included.
Key exclusion criteria (5 listed)
- Unfitness for general anesthesia and operation.
- Age < 18 years or >70 years.
- Complicated hernias (acute irreducible, obstruction or strangulation).
- The presence of mental or psychological disorders.
- Refusal to participate in the study.
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 |
|---|---|---|
| Transabdominal preperitoneal (TAPP) using polyprolene meshTransabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh | Procedure or surgery | Transabdominal preperitoneal (TAPP) |
| Total extraperitoneal (TEP) hernioplasty using polyprolene meshTotal extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh | Procedure or surgery | Total extraperitoneal (TEP) approach |
Primary outcome
Postoperative pain
Time frame: 6 months
by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.
2 secondary outcomes
operative time
Time frame: 6 months
complications
Time frame: 6 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 22 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.
Islam Hisham, MSc principal investigator
Mansoura University 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 Transabdominal preperitoneal (TAPP) using polyprolene mesh and Total extraperitoneal (TEP) hernioplasty using polyprolene mesh in people with Recurrent Inguinal Hernia, run by Mansoura 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 5 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 22 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 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 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 22 Sep 2023.