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SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair (LESSTEP)

Primary Purpose

Primary Unilateral Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
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
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Unilateral Inguinal Hernia focused on measuring Inguinal Hernia, Primary, laparoscopic surgery, single port surgery

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A: Standard TEP

Group B: LESS Port

Arm Description

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).

Outcomes

Primary Outcome Measures

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
Pain score (Visual Analog Scale) at 1 week after surgery
Assessment of pain according to the visual analog scale

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2013
Last Updated
April 7, 2017
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02302937
Brief Title
SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Unilateral Inguinal Hernia
Keywords
Inguinal Hernia, Primary, laparoscopic surgery, single port surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A: Standard TEP
Arm Type
Active Comparator
Arm Description
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
Arm Title
Group B: LESS Port
Arm Type
Active Comparator
Arm Description
Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical).
Intervention Type
Procedure
Intervention Name(s)
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )
Intervention Description
laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
Intervention Type
Procedure
Intervention Name(s)
Group B will undergo laparoscopic TEP inguinal hernia repair with a single port
Intervention Description
Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).
Primary Outcome Measure Information:
Title
Pain score (Visual Analog Scale) at 24hours after surgery
Description
Assessment of post-operative pain according to the visual analog scale Pain score will be taken, and painkiller consumption will be recorded
Time Frame
24 hours
Title
Pain score (Visual Analog Scale) at 1 week after surgery
Description
Assessment of pain according to the visual analog scale
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Recurrence of inguinal hernia
Description
Finding of hernia again during examination after surgery
Time Frame
1-3-6 months
Title
Post-operative complications
Description
Examining for any seroma, hematoma and skin ecchymosis
Time Frame
1-3-6 months
Title
Pain score (Visual Analog Scale) at 1-3-6 months after surgery
Description
Assessment of pain according to the visual analog scale
Time Frame
1-3-6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
10488834
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.
Results Reference
background
PubMed Identifier
22002266
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.
Results Reference
background
PubMed Identifier
21958305
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.
Results Reference
background
PubMed Identifier
19172350
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.
Results Reference
result
PubMed Identifier
32123978
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.
Results Reference
derived

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SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair

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