SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair (LESSTEP)

National University Health System (NUHS)

Status: Completed

Conditions: Primary Unilateral Inguinal Hernia

Treatments: Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single port; Procedure: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )

Study type: Interventional

Funder types: Other

Identifiers

NCT02302937

D/11/092 (Other Identifier)

2011/00092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups

group A: Standard TEP

Active Comparator group

Description:

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

Treatment:

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

Group B: LESS Port

Active Comparator group

Description:

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

Treatment:

Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single port