NCT02723045

Brief Summary

To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Status
unknown

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

First Submitted

Initial submission to the registry

March 14, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

March 14, 2016

Last Update Submit

March 24, 2016

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Carolina Comfort Scale

    12 months

Secondary Outcomes (4)

  • Operating time

    12 months

  • Duration of hospitalization

    12 months

  • Complications

    12 monthts

  • Recurrence

    12 months

Study Arms (2)

Open modified Lichtenstein repair

ACTIVE COMPARATOR

Patients will undergo open repair of their inguinal hernias

Procedure: Open Lichtenstein Hernioplasty

Laparoscopic TEP inguinal hernia repair

ACTIVE COMPARATOR

Patients will undergo laparoscopic repair of their inguinal hernias

Procedure: Laparoscopic TEP Hernioplasty

Interventions

Open Lichtenstein HernioplastyPROCEDURE
Open modified Lichtenstein repair
Laparoscopic TEP HernioplastyPROCEDURE
Laparoscopic TEP inguinal hernia repair

Eligibility Criteria

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

You may qualify if:

  • years of age and older
  • Both genders
  • Unilateral inguinal hernias
  • Reducible inguinal hernias
  • Elective setting

You may not qualify if:

  • ASA Physical Status (American Society of Anaesthesiologists) Grade \> 2
  • Recurrence
  • Inguinal-scrotal hernias
  • Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
  • Pregnancy
  • Refusal for general anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 30, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

September 1, 2017

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share