NCT06327763

Brief Summary

postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair. Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 16, 2024

Last Update Submit

March 22, 2024

Conditions

Ilioinguinal Nerve SectionPain PreventionHernioplasty

Outcome Measures

Primary Outcomes (1)

  • detect postoperative pain using short form inguinal pain questionnaire

    ask the patient for presence of postoperative pain using short form inguinal pain questionnaire

    3 months following operation then continous

Study Arms (2)

inguinal hernioplasty with ilioinguinal nerve preservation

NO INTERVENTION

inguinal hernioplasty with ilioinguinal nerve section

EXPERIMENTAL
Procedure: ilioinguinal nerve section

Interventions

ilioinguinal nerve sectionPROCEDURE

patients operated on by open inguinal hernioplasty with ilioinguinal neurectomy

inguinal hernioplasty with ilioinguinal nerve section

Eligibility Criteria

Age16 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- the study included all adult patients operated on for unilateral inguinal hernia by Lichtenstein tension-free mesh hernioplasty with or without ilioinguinal neurectomy.

You may not qualify if:

  • patients with recurrent inguinal hernia, bilateral inguinal hernia repair, or huge inguinoscrotal hernia were excluded. Diabetic patients as well as, patients with suspected inguinal hernia recurrence at the time of the questionnaire were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

yasmine Hegab

Zagazig, 7120730, Egypt

Location

Related Publications (1)

  • Orban YA, Hegab YH, Hamed AEM, Metwally H, Zakaria R, Goda AM, Baz Y. Prophylactic triple neurectomy during open tension-free inguinal hernia repair: a clinical trial for the prevention of chronic postoperative pain. Updates Surg. 2026 Jan 22. doi: 10.1007/s13304-025-02497-3. Online ahead of print.

    PMID: 41571965DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 25, 2024

Study Start

January 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 25, 2024

Record last verified: 2024-03

Locations

EG(1)