Laparscopic Hernioplasty in Recurrent Inguinal Hernia

NCT06050538 | Completed

• 1 other identifier: MD.21.03.439
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Inguinal Hernia

Keywords

TAPP; TEP; Laparoscopic Inguinal Hernia; Recurrent hernia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.

  6 months

Secondary Outcomes (2)

• operative time

  6 months

• complications

  6 months

Study Arms (2)

Transabdominal preperitoneal (TAPP)

ACTIVE COMPARATOR

patients with recurrent inguinal hernia who had Transabdominal preperitoneal (TAPP) approach

Procedure: Transabdominal preperitoneal (TAPP) using polyprolene mesh

Total extraperitoneal (TEP) approach

ACTIVE COMPARATOR

patients with recurrent inguinal hernia who had Total extraperitoneal (TEP) approach

Procedure: Total extraperitoneal (TEP) hernioplasty using polyprolene mesh

Interventions

Transabdominal preperitoneal (TAPP) using polyprolene mesh PROCEDURE

Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh

Transabdominal preperitoneal (TAPP)

Total extraperitoneal (TEP) hernioplasty using polyprolene mesh PROCEDURE

Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh

Total extraperitoneal (TEP) approach

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitl

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia

Interventions

tetra-4-amidinophenoxypropane; tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Islam Hisham, MSc

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Each patient was randomly allocated to the TAPP group or the TEP group by sequentially numbered, opaque , sealed envelope (SNOSE) technique on the day of surgery. An independent statistician , who was not involved in patient care, generated the randomization sequence via a computer generated random number. The randomization code was contained in opaque sealed envelopes. A junior resident , who opened the envelope , was not actively involved in outcome measurements .Before randomization and during the consent, all patients received an explanation of the objectives of the study, techniques and complications associated with both procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 22, 2023
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

EG (1)