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

A Prospective, Randomized, Controlled Trial to Compare Single Port Laparoscopic TEP Inguinal Hernia Repair Versus Standard Laparoscopic (3 Port) TEP Inguinal Hernia Mesh Repair

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.

Study Overview

• Status: Completed
• Conditions: Primary Unilateral Inguinal Hernia
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Publications and helpful links

General Publications

• Piskun G, Rajpal S. Transumbilical laparoscopic cholecystectomy utilizes no incisions outside the umbilicus. J Laparoendosc Adv Surg Tech A. 1999 Aug;9(4):361-4. doi: 10.1089/lap.1999.9.361.
• Goel R, Buhari SA, Foo J, Chung LK, Wen VL, Agarwal A, Lomanto D. Single-incision laparoscopic appendectomy: prospective case series at a single centre in Singapore. Surg Laparosc Endosc Percutan Tech. 2011 Oct;21(5):318-21. doi: 10.1097/SLE.0b013e3182311bd9.
• Goo TT, Agarwal A, Goel R, Tan CT, Lomanto D, Cheah WK. Single-port access adrenalectomy: our initial experience. J Laparoendosc Adv Surg Tech A. 2011 Nov;21(9):815-9. doi: 10.1089/lap.2011.0179. Epub 2011 Sep 29.
• Filipovic-Cugura J, Kirac I, Kulis T, Jankovic J, Bekavac-Beslin M. Single-incision laparoscopic surgery (SILS) for totally extraperitoneal (TEP) inguinal hernia repair: first case. Surg Endosc. 2009 Apr;23(4):920-1. doi: 10.1007/s00464-008-0318-x. Epub 2009 Jan 27. No abstract available.
• Chia DKA, Lomanto D, Wijerathne S. Patient-Reported Outcomes and Long-Term Results of a Randomized Controlled Trial Comparing Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair. World J Surg. 2020 Jul;44(7):2191-2198. doi: 10.1007/s00268-020-05443-z.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: laparoscopic surgery; Primary; Inguinal Hernia; single port surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 2011/00092; D/11/092 (Other Identifier: NUHS SIngapore)