SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair

Not Applicable

Completed

• Conditions: Primary Unilateral Inguinal Hernia
• Interventions: Procedure: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ); Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single port

• Registration Number: NCT02302937
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia using a mesh carried out with only 1 port (hole) results in the reduction of post- operative pain and use of painkillers, shorter hospital stay and lesser complications than that carried out using conventional 3 ports.

Detailed Description

100 patients undergoing laparoscopic TEP ( Total extraperitoneal repair) inguinal hernia repair under general anaesthesia will be randomized into 2 groups by the closed envelope method. In case of difficulty in Single port TEP inguinal hernia repair, the procedure will be converted to conventional 3 port repair for patient safety.

2 groups of participants: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical).

Patient will be informed at consenting that 3 wound plasters will be applied to their abdomen regardless of whether they are in the single port or 3- ports group so that they would not know which group they have been randomized to. The blind will only be lifted after pain score and area of pain has been recorded before discharge.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-12-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Age: 21- 80 yrs

• Informed consent
• Diagnosis of Hernia
• ASA I and II
• BMI<25.

Exclusion Criteria

Bleeding disorders

• Age below 21
• Strangulated Hernia
• BMI > 30
• Incarcerated and obstructed hernia
• Recurrent hernia
• Bilateral hernia
• Previous LSCS
• Previous lower abdominal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group A: Standard TEP	Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )	Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
Group B: LESS Port	Group B will undergo laparoscopic TEP inguinal hernia repair with a single port	Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical).

Primary Outcome Measures

Name	Time	Method
Pain score (Visual Analog Scale) at 24hours after surgery	24 hours	Assessment of post-operative pain according to the visual analog scale Pain score will be taken, and painkiller consumption will be recorded
Pain score (Visual Analog Scale) at 1 week after surgery	1 week	Assessment of pain according to the visual analog scale

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	1-3-6 months	Examining for any seroma, hematoma and skin ecchymosis
Recurrence of inguinal hernia	1-3-6 months	Finding of hernia again during examination after surgery
Pain score (Visual Analog Scale) at 1-3-6 months after surgery	1-3-6 months	Assessment of pain according to the visual analog scale

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore