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Evaluating the recurrence rate and adverse events of transversalis muscle fascia repair in total extraperitoneal repair (TEP) of inguinal hernia

Evaluating the recurrence rate and adverse events of transversalis muscle fascia repair in total extraperitoneal repair (TEP) of inguinal hernia in Isfahan Al Zahra Hospital autom and winter of 1402: a double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180312039067N2
Enrollment
60
Registered
2024-02-29
Start date
2024-03-05
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal hernia. Inguinal hernia

Interventions

Intervention 1: Control group: The inguinal canal will be repaired with the TEP method based on the published guidelines, and the mesh will be inserted without fixation. Intervention 2: Intervention g

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: No history of abdominal surgery below the umbilical line Primary direct hernia or unilateral or bilateral recurrent hernia No history of mesh implantation BMI less than or equal to 40 No history of liver disorder characterized by ascites No history of renal failure failure to complete written consent

Exclusion criteria

Exclusion criteria: Need to repair inguinal hernia with open surgery Strangulated inguinal hernia

Design outcomes

Primary

MeasureTime frame
Operation time. Timepoint: First randomization day. Method of measurement: STOPWATCH.;Hospitalization time. Timepoint: First randomization day. Method of measurement: Documentation in medical records.

Secondary

MeasureTime frame
Recurrence. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Clinical exam.;Pain. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Visual Analogue Scale (VAS) measures pain intensity.;Seroma. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Ultrasonography.;Infection. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Clinical exam.;Analgesics. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: History taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPedram Hadipour

Esfahan University of Medical Sciences

pmhr??@gmail.com+98 31 3651 8499

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026