NCT04149847

Brief Summary

Inguinal hernia repair may be done by the nylon darn, polypropylene mesh and other methods. Polypropylene mesh is established in the literature as the standard of care for inguinal hernia repair. It is however expensive and not readily available in our community hospitals. Nylon darn repair is widely used in our hospitals. We think that the quality of life following nylon darn repair and polypropylene mesh repair is similar. In order to find out, we are recruiting 79 patients to undergo nylon darn repair for their inguinal hernia and another 79 patients to undergo polypropylene mesh repair for their inguinal hernia repair. We are doing research to compare the quality of life after nylon darn repair of inguinal hernia to polypropylene mesh repair in patients aged 18 years to 80 years who come to St. Luke Hospital for their first-ever inguinal hernia repair.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

November 7, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

October 30, 2019

Last Update Submit

November 5, 2019

Conditions

Hernia, InguinalHernia DirectHernias IndirectQuality of Life

Keywords

inguinal herniaquality of lifeCOMI-herniapolypropylene mesh repairnylon darn repairpatient-reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Core Outcome Measures Index - Hernia (COMI - Hernia) score to measure quality of life

    Pre-operative COMI-hernia score compared to post-operative COMI-hernia score. The score ranges from 0 to 10. A higher score correlates with a worse outcome and lower scores indicate good outcomes

    3 months

Secondary Outcomes (4)

  • Number of participants with surgical site infection

    5 days

  • Number of participants with seroma

    3 to 7 days

  • Number of participants with scrotal/wound haematoma

    3 to 7 days

  • Number of participants with testicular swelling

    3 to 7 days

Study Arms (2)

Nylon darn repair

EXPERIMENTAL

a nylon #1 suture to be used to reconstruct the posterior inguinal wall

Procedure: inguinal hernia repair

polypropylene mesh repair

EXPERIMENTAL

a commercially available 7.5cm x 15cm sheet of polypropylene mesh to be trimmed to fit the posterior inguinal wall

Procedure: inguinal hernia repair

Interventions

inguinal hernia repairPROCEDURE

patients 18 years and above presenting with primary inguinal hernia

Nylon darn repairpolypropylene mesh repair

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, 18 years and above, presenting with primary reducible inguinal hernias
  • Patients, 18 years and above, with irreducible inguinal hernias which is neither obstructed nor strangulated.

You may not qualify if:

  • Patients who do not consent to participate in the study.
  • Patients presenting with recurrent, obstructed or strangulated hernias
  • Patients with bilateral hernias
  • Patients with immunosuppression (uncontrolled diabetes mellitus, malnutrition, patients on long-term steroids, known AIDS patients)
  • Patients with chronic debilitating illnesses (chronic renal or liver failure, congestive cardiac failure) and urinary bladder outlet obstruction
  • Concomitant repair of another abdominal hernia e.g. umbilical hernia
  • Hernia repair combined with another surgical procedure
  • Patients under the age of 18 years and over 80 years
  • Pregnant women
  • ASA score 4 or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke Hospital

Ejura, Ashanti Region, Ghana

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Edward A Boateng, MBChB,MGCS,MWACS

    West African College of Surgeons

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward A Boateng, MBChB,MGCS,MWACS

CONTACT

+233244222366eaboateng@hotmail.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 4, 2019

Study Start

November 1, 2019

Primary Completion

June 30, 2020

Study Completion

September 29, 2020

Last Updated

November 7, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GH(1)