Clinical trial NCT02302937: SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Unilateral Inguinal Hernia
Keywords: Inguinal Hernia
Primary
laparoscopic surgery
single port surgery
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score (Visual Analog Scale) at 24hours after surgery
timeFrame: 24 hours
measure: Pain score (Visual Analog Scale) at 1 week after surgery
timeFrame: 1 week
Secondary outcomes:
measure: Recurrence of inguinal hernia
timeFrame: 1-3-6 months
measure: Post-operative complications
timeFrame: 1-3-6 months
measure: Pain score (Visual Analog Scale) at 1-3-6 months after surgery
timeFrame: 1-3-6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.