Primary Unilateral Inguinal HerniaLESSTEPNCT02302937
SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair
A study testing Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ) and Group B will undergo laparoscopic TEP inguinal hernia repair with a single port in people with Primary Unilateral Inguinal Hernia, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, men only
- Conditions the study is for
- Primary Unilateral Inguinal Hernia
- What is being tested?
- Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ) and Group B will undergo laparoscopic TEP inguinal hernia repair with a single port
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 21- 80 yrs
- Informed consent
- Diagnosis of Hernia
- ASA I and II
- BMI<25.
Who cannot join
- Bleeding disorders
- Age below 21
- Strangulated Hernia
- BMI > 30
- Incarcerated and obstructed hernia
- Recurrent hernia
Show all 9Show fewer
- Bilateral hernia
- Previous LSCS
- Previous lower abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Primary Unilateral Inguinal Hernia
- Being tested
- 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
- Keywords
- Inguinal Hernia, Primary, laparoscopic surgery, single port surgery
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )Procedure or surgery
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 portProcedure or surgery
Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).
| Study group | Role | What they receive |
|---|---|---|
| group A: Standard TEP | Active comparator | Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). Receives: Procedure: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ) |
| Group B: LESS Port | Active comparator | Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical). Receives: Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single port |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Pain score (Visual Analog Scale) at 1 week after surgery
Assessment of pain according to the visual analog scale
Measured: 1 week
Secondary outcomes (3)
Recurrence of inguinal hernia
Finding of hernia again during examination after surgery
Measured: 1-3-6 months
Post-operative complications
Examining for any seroma, hematoma and skin ecchymosis
Measured: 1-3-6 months
Pain score (Visual Analog Scale) at 1-3-6 months after surgery
Assessment of pain according to the visual analog scale
Measured: 1-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary Unilateral Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302937
- Sponsor's protocol ID
- 2011/00092
- Other IDs
- D/11/092
- Acronym
- LESSTEP
- Status last verified
- Nov 2014
- First submitted
- 5 Dec 2013
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10488834Goel 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.
PubMed 22002266Goo 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.
PubMed 21958305Filipovic-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.
PubMed 19172350Chia 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.
PubMed 32123978
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02302937
- Acronym / sponsor ID
- LESSTEP / 2011/00092
- Conditions
- Primary Unilateral Inguinal Hernia
- Keywords
- Inguinal Hernia, Primary, laparoscopic surgery, single port surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: Standard TEP | Active comparator | Procedure: Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). |
| Group B: LESS Port | Active comparator | Procedure: Group B will undergo laparoscopic TEP inguinal hernia repair with a single portGroup B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm transumbilical). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 21- 80 yrs
- Informed consent
- Diagnosis of Hernia
- ASA I and II
- BMI<25.
Key exclusion criteria (9 listed)
- Bleeding disorders
- Age below 21
- Strangulated Hernia
- BMI > 30
- Incarcerated and obstructed hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ). | Procedure or surgery | group A: Standard TEP |
| Group B will undergo laparoscopic TEP inguinal hernia repair with a single portGroup B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical). | Procedure or surgery | Group B: LESS Port |
Primary outcome
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
3 secondary outcomes
Recurrence of inguinal hernia
Time frame: 1-3-6 months
Post-operative complications
Time frame: 1-3-6 months
Pain score (Visual Analog Scale) at 1-3-6 months after surgery
Time frame: 1-3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 10488834Piskun 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.
- Background: PubMed 22002266Goel 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.
- Background: PubMed 21958305Goo 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 publication: PubMed 19172350Filipovic-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.
- Derived from this study: PubMed 32123978Chia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ) and Group B will undergo laparoscopic TEP inguinal hernia repair with a single port in people with Primary Unilateral Inguinal Hernia, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (Visual Analog Scale) at 24hours after surgery (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302937, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.