Hernia, InguinalNCT06270472
Transinguinal Periperitoneal Technique in Inguinal Hernioplasty
An observational study of Hernia, Inguinal, run by Assiut University.
Trial summary
evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- hernioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- How long will I take part?
- 1 Year
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 1. Patients more than 18 years 2. fit for surgery. 1-Patients less than 18 years 2- ASA 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina \& implanted pacemaker
Who may be able to join
- Patients more than 18 years
- fit for surgery.
Who cannot join
- Patients less than 18 years
- American Society of Anesthesiologists (ASA) 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina \& implanted pacemaker ) .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Trans Inguinal Periperitoneal Technique in Inguinal Hernioplasty at General Surgery Department in Assiut University Hospitals
evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals
Read the detailed description
Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide with approximately 20 million cases every year . The open Lichtenstein tension-free hernioplasty is most commonly performed and recognized for its low recurrence rate and short learning curve, but associated with an undesirably high level of postoperative chronic groin pain, up to 10-35% . Therefore, chronic groin pain is a common concern after inguinal hernia surgery. Treatment of chronic groin pain can be challenging and may require several interventions including, local anaesthesia , corticosteroids or additional surgery . Several studies showed that chronic groin pain might be dependent on the surgical technique, including identification and handling of inguinal nerves ,Preperitoneal techniques like the transinguinal preperitoneal patch (TIPP )have been developed to minimize these risks. The TIPP technique which introduced by prissier involves a standard anterior inguinal approach, with high dissection and preperitoneal reduction use of a PolySoft mesh have been proved to cause less chronic pain than the Lichtenstein technique. The PolySoft mesh is a lightweight polypropylene mesh, tailored in asymmetric oval shape that contains a recoil ring. Recent studies deficient in evaluation feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh in inguinal hernia repair . So the aim of our study to evaluate the use of conventional mesh in transinguinal preperitoneal technique in inguinal hernioplasty .
- Conditions
- Hernia, Inguinal
- Being tested
- hernioplasty
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernioplastyProcedure or surgery
The polysome repair was carried out as described by pelisse . In the case of a lateral hernia, the spermatic cord was mobilised and the cremasteric fibers were separated (in men). The hernia sac was dissected from the cord structures and reduced in the preperitoneal space through the internal ring. A dissection gauze was inserted through the internal ring to create the preperitoneal space. The medial border of the internal ring and the epigastric vessels were lifted with a refractor and blunt digital dissection was carried out in the preperitoneal space in all directions. A pocket was created to allow a complete expansion of the mesh. The conventional mesh was introduced with blunt forceps and, after the gauze has been removed, positioned in the preperitoneal space .
In the case of a medial hernia, the preperitoneal space was reached by incising the transversalis fascia around the base of the sac. Completion of the repair is the same as the lateral hernia procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of inguinal hernia 2 years follow up .
Recurrence rate of inguinal hernia 2 years follow up .
Measured: 2 years
Numerical rating score of pain
Uses numbers to rate postoperative pain
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Mohamed Elsayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270472
- Sponsor's protocol ID
- tipp technique
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Messias BA, Almeida PL, Ichinose TMS, Mocchetti ER, Barbosa CA, Waisberg J, Roll S, Ribeiro Junior MF. The Lichtenstein technique is being used adequately in inguinal hernia repair: national analysis and review of the surgical technique. Rev Col Bras Cir. 2023 Dec 8;50:e20233655. doi: 10.1590/0100-6991e-20233655-en. eCollection 2023.
PubMed 38088634Damous SHB, Damous LL, Borges VA, Fontella AK, Miranda JDS, Koike MK, Saito OC, Birolini CAV, Utiyama EM. Bilateral inguinal hernia repair and male fertility: a randomized clinical trial comparing Lichtenstein versus laparoscopic transabdominal preperitoneal (TAPP) technique. Surg Endosc. 2023 Dec;37(12):9263-9274. doi: 10.1007/s00464-023-10499-8. Epub 2023 Oct 25.
PubMed 37880447Shekouhi R, Farz F, Sohooli M, Mohammadi S, Abbasi A, Razaghi M, Fereydouni M, Sohrabi M, Seyed-Alagheband SA, Darabi MH. Investigating the safety and efficacy of nerve stimulation for management of groin pain after surgical herniorrhaphy: a systematic review and meta-analysis. Hernia. 2023 Dec;27(6):1363-1373. doi: 10.1007/s10029-023-02861-5. Epub 2023 Aug 19.
PubMed 37597107
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Inguinal Periperitoneal Technique in Inguinal Hernioplasty at General Surgery Department in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT06270472
- Acronym / sponsor ID
- tipp technique
- Conditions
- Hernia, Inguinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 21 Feb 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.
evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals
Detailed description
Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide with approximately 20 million cases every year . The open Lichtenstein tension-free hernioplasty is most commonly performed and recognized for its low recurrence rate and short learning curve, but associated with an undesirably high level of postoperative chronic groin pain, up to 10-35% . Therefore, chronic groin pain is a common concern after inguinal hernia surgery. Treatment of chronic groin pain can be challenging and may require several interventions including, local anaesthesia , corticosteroids or additional surgery . Several studies showed that chronic groin pain might be dependent on the surgical technique, including identification and handling of inguinal nerves ,Preperitoneal techniques like the transinguinal preperitoneal patch (TIPP )have been developed to minimize these risks. The TIPP technique which introduced by prissier involves a standard anterior inguinal approach, with high dissection and preperitoneal reduction use of a PolySoft mesh have been proved to cause less chronic pain than the Lichtenstein technique. The PolySoft mesh is a lightweight polypropylene mesh, tailored in asymmetric oval shape that contains a recoil ring. Recent studies deficient in evaluation feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh in inguinal hernia repair . So the aim of our study to evaluate the use of conventional mesh in transinguinal preperitoneal technique in inguinal hernioplasty .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1. Patients more than 18 years 2. fit for surgery. 1-Patients less than 18 years 2- ASA 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina \& implanted pacemaker
Key inclusion criteria (2 listed)
- Patients more than 18 years
- fit for surgery.
Key exclusion criteria (2 listed)
- Patients less than 18 years
- American Society of Anesthesiologists (ASA) 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina \& implanted pacemaker ) .
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 |
|---|---|---|
| hernioplastyThe polysome repair was carried out as described by pelisse . In the case of a lateral hernia, the spermatic cord was mobilised and the cremasteric fibers were separated (in men). The hernia sac was dissected from the cord structures and reduced in the preperitoneal space through the internal ring. A dissection gauze was inserted through the internal ring to create the preperitoneal space. The medial border of the internal ring and the epigastric vessels were lifted with a refractor and blunt digital dissection was carried out in the preperitoneal space in all directions. A pocket was created to allow a complete expansion of the mesh. The conventional mesh was introduced with blunt forceps and, after the gauze has been removed, positioned in the preperitoneal space . In the case of a medial hernia, the preperitoneal space was reached by incising the transversalis fascia around the base of the sac. Completion of the repair is the same as the lateral hernia procedure. | Procedure or surgery | – |
Primary outcome
Recurrence rate of inguinal hernia 2 years follow up .
Time frame: 2 years
Recurrence rate of inguinal hernia 2 years follow up .
Numerical rating score of pain
Time frame: 1year
Uses numbers to rate postoperative pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 38088634Messias BA, Almeida PL, Ichinose TMS, Mocchetti ER, Barbosa CA, Waisberg J, Roll S, Ribeiro Junior MF. The Lichtenstein technique is being used adequately in inguinal hernia repair: national analysis and review of the surgical technique. Rev Col Bras Cir. 2023 Dec 8;50:e20233655. doi: 10.1590/0100-6991e-20233655-en. eCollection 2023.
- Background: PubMed 37880447Damous SHB, Damous LL, Borges VA, Fontella AK, Miranda JDS, Koike MK, Saito OC, Birolini CAV, Utiyama EM. Bilateral inguinal hernia repair and male fertility: a randomized clinical trial comparing Lichtenstein versus laparoscopic transabdominal preperitoneal (TAPP) technique. Surg Endosc. 2023 Dec;37(12):9263-9274. doi: 10.1007/s00464-023-10499-8. Epub 2023 Oct 25.
- Background: PubMed 37597107Shekouhi R, Farz F, Sohooli M, Mohammadi S, Abbasi A, Razaghi M, Fereydouni M, Sohrabi M, Seyed-Alagheband SA, Darabi MH. Investigating the safety and efficacy of nerve stimulation for management of groin pain after surgical herniorrhaphy: a systematic review and meta-analysis. Hernia. 2023 Dec;27(6):1363-1373. doi: 10.1007/s10029-023-02861-5. Epub 2023 Aug 19.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed elsayed (01021892279, elsayedahmed994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of inguinal hernia 2 years follow up . (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT06270472, which also lists 3 linked publications.
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 21 Feb 2024.