NCT05574751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 22, 2022

Status Verified

January 1, 2022

Enrollment Period

4.2 years

First QC Date

October 7, 2022

Last Update Submit

November 19, 2022

Conditions

Inguinal Hernia Unilateral

Keywords

Inguinal herniaMesh fixationTitanium tacker

Outcome Measures

Primary Outcomes (2)

  • 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)

    7 days after the end of the operation

  • 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)

    7 days after the end of the operation

Secondary Outcomes (4)

  • Mean and Standard deviation of Operative duration (minutes) (mean±SD)

    2 minutes after the end of the operation

  • Mean and Standard deviation of Length of hospital stay (hours) (mean±SD)

    24 hours after the end of the operation

  • Number of participants and Rate of Intraoperative complications

    2 minutes after the end of the operation

  • Number of participants and Rate of Postoperative complications

    1 year after the end of the operation

Study Arms (2)

Titanium tacker group (n=30)

ACTIVE COMPARATOR

Group A

Other: Titanium tacker

Polypropylene group (n=30)

ACTIVE COMPARATOR

Group B

Other: Polypropylene 0

Interventions

Titanium tackerOTHER

Mesh fixation with Titanium tacker

Titanium tacker group (n=30)
Polypropylene 0OTHER

Mesh was sutured and fixed with polypropylene 0

Polypropylene group (n=30)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

September 1, 2018

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

November 22, 2022

Record last verified: 2022-01

Locations

EG(1)