NCT02788812

Brief Summary

To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic transabdominal pre-peritoneal (TAPP) 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 Jun 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

May 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

May 21, 2016

Last Update Submit

May 28, 2016

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Quality of life scores as measured by Carolinas Comfort Scale

    Carolina Comfort Scale during the duration of follow-up

    12 months

Secondary Outcomes (3)

  • Operating Time in Minutes

    12 months

  • Duration of Hospitalization in Days

    12 months

  • Recurrence of Hernia after Operation

    12 monthts

Study Arms (2)

Open modified Lichtenstein repair

ACTIVE COMPARATOR
Procedure: Open modified Lichtenstein repair

Laparoscopic TAPP inguinal hernia repair

ACTIVE COMPARATOR
Procedure: Laparoscopic TAPP inguinal hernia repair

Interventions

Open modified Lichtenstein repairPROCEDURE

Open Lichtenstein Hernioplasty

Open modified Lichtenstein repair
Laparoscopic TAPP inguinal hernia repairPROCEDURE

Laparoscopic TAPP Hernioplasty

Laparoscopic TAPP 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
  • Incarcerated inguinal hernias
  • Elective setting

You may not qualify if:

  • 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
Dr

Study Record Dates

First Submitted

May 21, 2016

First Posted

June 2, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2017

Study Completion

December 1, 2017

Last Updated

June 2, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share