Laparscopic Hernioplasty in Recurrent Inguinal Hernia

NCT ID: NCT06050538

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Inguinal Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transabdominal preperitoneal (TAPP)

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

Group Type ACTIVE_COMPARATOR

Transabdominal preperitoneal (TAPP) using polyprolene mesh

Intervention Type PROCEDURE

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

Total extraperitoneal (TEP) approach

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

Group Type ACTIVE_COMPARATOR

Total extraperitoneal (TEP) hernioplasty using polyprolene mesh

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transabdominal preperitoneal (TAPP) using polyprolene mesh

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

Intervention Type PROCEDURE

Total extraperitoneal (TEP) hernioplasty using polyprolene mesh

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Islam Hisham

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Islam Hisham, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University Hospitl

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MD.21.03.439

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Transabdominal Preperitoneal Inguinal Hernia Repair
NCT05839587 ACTIVE_NOT_RECRUITING NA
Repair of Inguinal Hernia
NCT06514859 RECRUITING NA