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Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

Primary Purpose

Inguinal Hernia Unilateral

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Titanium tacker
Polypropylene 0
Sponsored by
Damanhour Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia Unilateral focused on measuring Inguinal hernia, Mesh fixation, Titanium tacker

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 21 years
  • American Society of Anesthesiologists (ASA) physical status ≤ II
  • Patients with body mass index (BMI) of 25 to 35 kg/m²
  • Unilateral inguinal hernia

Exclusion Criteria:

  • Age < 21 years
  • ASA physical status > II
  • Patients with body mass index (BMI) > 35 kg/m²
  • Pregnant women
  • Bilateral inguinal hernia
  • Large inguinoscrotal hernia
  • Incarcerated hernia
  • Recurrent hernia
  • Strangulated hernia
  • Prostatic diseases
  • History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
  • Dysrhythmia
  • Hypertension
  • Ischemic heart disease
  • Hyperthyroidism
  • Liver or Renal impairment
  • Alcohol or drug abuse

Sites / Locations

  • Damanhour Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Titanium tacker group (n=30)

Polypropylene group (n=30)

Arm Description

Group A

Group B

Outcomes

Primary Outcome Measures

Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)

Secondary Outcome Measures

Mean and Standard deviation of Operative duration (minutes) (mean±SD)
Time from skin incision till skin closure
Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)
Time from hospital admission till discharge
Number of participants and Rate of Intraoperative complications
Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury.
Number of participants and Rate of Postoperative complications
Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence.

Full Information

First Posted
October 7, 2022
Last Updated
November 19, 2022
Sponsor
Damanhour Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05574751
Brief Title
Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
Official Title
Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour Teaching Hospital

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
Background: Mesh fixation is a critical step in laparoscopic Transabdominal Preperitoneal (TAPP) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. Fixation is more expensive than non-fixation. Objective: To compare the efficiency of mesh fixation in laparoscopic TAPP surgical repair of inguinal hernia using sutured repair versus tacker use. Patients and Methods: This prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic TAPP hernia repair. Patients were randomly allocated into two equal groups (30 patients each); in group A, the mesh was fixed with a Titanium tacker, and in group B, the mesh was sutured and fixed with polypropylene 0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Unilateral
Keywords
Inguinal hernia, Mesh fixation, Titanium tacker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Titanium tacker group (n=30)
Arm Type
Active Comparator
Arm Description
Group A
Arm Title
Polypropylene group (n=30)
Arm Type
Active Comparator
Arm Description
Group B
Intervention Type
Other
Intervention Name(s)
Titanium tacker
Intervention Description
Mesh fixation with Titanium tacker
Intervention Type
Other
Intervention Name(s)
Polypropylene 0
Intervention Description
Mesh was sutured and fixed with polypropylene 0
Primary Outcome Measure Information:
Title
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
Description
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Time Frame
7 days after the end of the operation
Title
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Description
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (2h, 6h, 12h, 24h, 48h, 72h, and 7 days)
Time Frame
7 days after the end of the operation
Secondary Outcome Measure Information:
Title
Mean and Standard deviation of Operative duration (minutes) (mean±SD)
Description
Time from skin incision till skin closure
Time Frame
2 minutes after the end of the operation
Title
Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)
Description
Time from hospital admission till discharge
Time Frame
24 hours after the end of the operation
Title
Number of participants and Rate of Intraoperative complications
Description
Number of participants and Rate of: Bowel injury, Injury to inferior epigastric artery, Injury to major vessels, Bleeding of venous plexus around pubic bone, Injury to vas deferens, Bladder injury.
Time Frame
2 minutes after the end of the operation
Title
Number of participants and Rate of Postoperative complications
Description
Number of participants and Rate of: Cord edema, Seroma, Port-site infection, Inguinal anesthesia/hyperthesia, Chronic pain, Recurrence.
Time Frame
1 year after the end of the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 years American Society of Anesthesiologists (ASA) physical status ≤ II Patients with body mass index (BMI) of 25 to 35 kg/m² Unilateral inguinal hernia Exclusion Criteria: Age < 21 years ASA physical status > II Patients with body mass index (BMI) > 35 kg/m² Pregnant women Bilateral inguinal hernia Large inguinoscrotal hernia Incarcerated hernia Recurrent hernia Strangulated hernia Prostatic diseases History of; Convulsions, Cerebrovascular accident, Previous neurological diseases Dysrhythmia Hypertension Ischemic heart disease Hyperthyroidism Liver or Renal impairment Alcohol or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour Teaching Hospital
City
Damanhūr
State/Province
El-Beheira
Country
Egypt

12. IPD Sharing Statement

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Laparoscopic Transabdominal Preperitoneal Surgical Repair of Inguinal Hernia Using Sutured Repair Versus Tacker Use

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