NCT06270472

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

December 20, 2023

Last Update Submit

February 18, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recurrence rate of inguinal hernia 2 years follow up .

    Recurrence rate of inguinal hernia 2 years follow up .

    2 years

  • Numerical rating score of pain

    Uses numbers to rate postoperative pain

    1year

Interventions

hernioplastyPROCEDURE

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients more than 18 years
  • fit for surgery.

You may not qualify if:

  • 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 ) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 38088634BACKGROUND
  • 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.

    PMID: 37880447BACKGROUND
  • 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.

    PMID: 37597107BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2023

First Posted

February 21, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02