- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270472
Transinguinal Periperitoneal Technique in Inguinal Hernioplasty
February 18, 2024 updated by: Ahmed Elsayed Mohamed Elsayed, Assiut University
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ahmed elsayed
- Phone Number: 01021892279
- Email: elsayedahmed994@gmail.com
Study Contact Backup
- Name: morsy mohamed
- Phone Number: 01093688097
- Email: morssy@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Patients more than 18 years
- 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
Description
Inclusion Criteria:
- Patients more than 18 years
- fit for surgery.
Exclusion Criteria:
- 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 ) .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence rate of inguinal hernia 2 years follow up .
Time Frame: 2 years
|
Recurrence rate of inguinal hernia 2 years follow up .
|
2 years
|
|
Numerical rating score of pain
Time Frame: 1year
|
Uses numbers to rate postoperative pain
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Damous 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.
- Shekouhi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
December 20, 2023
First Submitted That Met QC Criteria
February 18, 2024
First Posted (Estimated)
February 21, 2024
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 18, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tipp technique
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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