A Prospective, Randomized, Controlled Trial to Compare Single Port Laparoscopic TEP Inguinal Hernia Repair Versus Standard Laparoscopic (3 Port) TEP Inguinal Hernia Mesh Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Unilateral Inguinal Hernia
- Sponsor
- National University Hospital, Singapore
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain score (Visual Analog Scale) at 24hours after surgery
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 21- 80 yrs
- •Informed consent
- •Diagnosis of Hernia
- •ASA I and II
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
Outcomes
Primary Outcomes
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
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
- Post-operative complications(1-3-6 months)
- Recurrence of inguinal hernia(1-3-6 months)
- Pain score (Visual Analog Scale) at 1-3-6 months after surgery(1-3-6 months)