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Laparscopic Hernioplasty in Recurrent Inguinal Hernia

Primary Purpose

Recurrent Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transabdominal preperitoneal (TAPP) using polyprolene mesh
Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Inguinal Hernia focused on measuring TAPP, TEP, Laparoscopic Inguinal Hernia, Recurrent hernia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Hospitl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transabdominal preperitoneal (TAPP)

Total extraperitoneal (TEP) approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

operative time
operative time by minutes was reported to get mean and standard deviation
complications
complications will be described as number and percentages in each group

Full Information

First Posted
August 21, 2023
Last Updated
September 21, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06050538
Brief Title
Laparscopic Hernioplasty in Recurrent Inguinal Hernia
Official Title
A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Inguinal Hernia
Keywords
TAPP, TEP, Laparoscopic Inguinal Hernia, Recurrent hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transabdominal preperitoneal (TAPP)
Arm Type
Active Comparator
Arm Description
patients with recurrent inguinal hernia who had Transabdominal preperitoneal (TAPP) approach
Arm Title
Total extraperitoneal (TEP) approach
Arm Type
Active Comparator
Arm Description
patients with recurrent inguinal hernia who had Total extraperitoneal (TEP) approach
Intervention Type
Procedure
Intervention Name(s)
Transabdominal preperitoneal (TAPP) using polyprolene mesh
Intervention Description
Transabdominal preperitoneal (TAPP) approach for recurrent inguinal hernia using polyprolene mesh
Intervention Type
Procedure
Intervention Name(s)
Total extraperitoneal (TEP) hernioplasty using polyprolene mesh
Intervention Description
Total extraperitoneal (TEP) approach for recurrent inguinal hernia using polyprolene mesh
Primary Outcome Measure Information:
Title
Postoperative pain
Description
by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
operative time
Description
operative time by minutes was reported to get mean and standard deviation
Time Frame
6 months
Title
complications
Description
complications will be described as number and percentages in each group
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Islam Hisham, MSc
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitl
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

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Laparscopic Hernioplasty in Recurrent Inguinal Hernia

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