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Completed

NCT Number: NCT02302937

SIngle Port vs Standard TEP for Primary Inguinal Hernia 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.

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Key information

Conditions

Primary Unilateral Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

21 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Procedure

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

Primary outcomes

  1. Pain score (Visual Analog Scale) at 24hours after surgery

    Time frame: 24 hours

    Assessment of post-operative pain according to the visual analog scale Pain score will be taken, and painkiller consumption will be recorded

  2. Pain score (Visual Analog Scale) at 1 week after surgery

    Time frame: 1 week

    Assessment of pain according to the visual analog scale

Secondary outcomes

  1. Recurrence of inguinal hernia

    Time frame: 1-3-6 months

    Finding of hernia again during examination after surgery

  2. Post-operative complications

    Time frame: 1-3-6 months

    Examining for any seroma, hematoma and skin ecchymosis

  3. Pain score (Visual Analog Scale) at 1-3-6 months after surgery

    Time frame: 1-3-6 months

    Assessment of pain according to the visual analog scale

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Acronym: LESSTEP

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2014
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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