Primary Unilateral Inguinal Hernia
Conditions
Keywords
Inguinal Hernia, Primary, laparoscopic surgery, single port surgery
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.
Interventions
PROCEDUREGroup 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 ).
PROCEDUREGroup 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).
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of inguinal hernia | 1-3-6 months | Finding of hernia again during examination after surgery |
| Post-operative complications | 1-3-6 months | Examining for any seroma, hematoma and skin ecchymosis |
| 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 |
Countries
Singapore
Outcome results
None listed