QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair

NCT ID: NCT02788812

Last Updated: 2016-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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Patients presenting with incarcerated inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open modified Lichtenstein repair

Group Type ACTIVE_COMPARATOR

Open modified Lichtenstein repair

Intervention Type PROCEDURE

Open Lichtenstein Hernioplasty

Laparoscopic TAPP inguinal hernia repair

Group Type ACTIVE_COMPARATOR

Laparoscopic TAPP inguinal hernia repair

Intervention Type PROCEDURE

Laparoscopic TAPP Hernioplasty

Interventions

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Open modified Lichtenstein repair

Open Lichtenstein Hernioplasty

Intervention Type PROCEDURE

Laparoscopic TAPP inguinal hernia repair

Laparoscopic TAPP Hernioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Both genders
* Unilateral inguinal hernias
* Incarcerated inguinal hernias
* Elective setting

Exclusion Criteria

* Anaesthesiologists) Grade \> 2
* Recurrence
* Inguinal-scrotal hernias
* Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
* Pregnancy
* Refusal for general anaesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sarawak General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Siow Sze Li

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NMRR-16-453-29942

Identifier Type: -

Identifier Source: org_study_id

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