SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair

Primary Unilateral Inguinal Hernia Clinical Trial

— LESSTEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302937
• Other study ID #: 2011/00092
• Secondary ID: D/11/092
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: April 7, 2017
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Primary Unilateral Inguinal Hernia

Intervention

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 ).
• 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).

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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 2 — View 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. — View 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. — View 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. — View Citation

Outcome

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