QOL in Incarcerated Inguinal Hernias: TAPP Vs Open Repair

Inguinal Hernia Clinical Trial

Official title:

The Comparison of the Quality of Life and Outcomes in Patient's With Incarcerated Inguinal Hernias: Laparoscopic Transabdominal Pre-peritoneal (TAPP) Versus Modified Lichtenstein Hernioplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02788812
• Other study ID #: NMRR-16-453-29942
• Status: Not yet recruiting
• Phase: N/A
• First received: May 21, 2016
• Last updated: May 28, 2016
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Sarawak General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Open modified Lichtenstein repair
Open Lichtenstein Hernioplasty
• Laparoscopic TAPP inguinal hernia repair
Laparoscopic TAPP Hernioplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sarawak General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life scores as measured by Carolinas Comfort Scale	Carolina Comfort Scale during the duration of follow-up	12 months	No
Secondary	Operating Time in Minutes	Comparing the duration of operation between open and laparoscopic surgeries.	12 months	No
Secondary	Duration of Hospitalization in Days	Comparing the duration of post operative stay between open and laparoscopic surgeries.	12 months	No
Secondary	Recurrence of Hernia after Operation	Comparing the recurrences between open and laparoscopic surgeries.	12 monthts	No