NCT05966285

Brief Summary

Purpose: Tension-free hernia repair is the gold standard for groin hernia repair. However, there is no consensus on the optimal surgical treatment for incarcerated groin hernia in elderly populations, The aim of this study was to compare the clinical efficacy of mesh repair and suture repair in the treatment of incarcerated groin hernia in elderly patients. Methods: Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 will be included. Patient demographic data and short-term and long-term postoperative outcomes will be retrospectively analyzed.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

July 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

July 21, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

Incarcerated groin herniaEmergency

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Recurrence is determined by physical examination or the patient's subjective perceptions

    at least one year

Secondary Outcomes (5)

  • length of hospital stay

    up to 3 months

  • length of ICU stay

    up to 3 months

  • surgery-related death

    within 30 days after surgery

  • surgical site infection

    within 30 days after surgery

  • overall complications

    at least 1 months

Study Arms (2)

suture group

Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.

Other: suture repair

mesh repair

Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.

Other: mesh repair

Interventions

Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.

suture group

Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.

mesh repair

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients ≥65 years diagnosed with incarcerated groin hernia (IGH) who underwent emergency surgical repair.

You may qualify if:

  • Patients diagnosed with incarcerated groin hernia (IGH).
  • Aged ≥65 years
  • Received emergency surgical repair (mesh or suture repair) at our center between January 2015 and June 2022.

You may not qualify if:

  • IGH patients did not undergo either mesh repair or suture repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 21, 2023

First Posted

July 28, 2023

Study Start

September 30, 2023

Primary Completion

July 20, 2024

Study Completion

July 20, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share