LESS TEP vs. Three Port TEP for Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia
Status
Active
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Standard 3 port TEP
LESS TEP
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring TEP, LESS TEP, Inguinal Hernia, Laparoscopic Surgery, Recurrence inguinal hernia, Primary inguinal hernia
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 90 years
- Willing to participate in this study and signed an informed consent.
- Diagnosed inguinal hernia - primary or recurrence
- ASA class I, II and III
Exclusion Criteria:
- Age under 18 years and above 90 years
- Strangulated hernia
- Patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia
- Patients who prefer a certain surgical approach
- Patients who undergo surgery procedures for chronic pain after inguinal hernia repair
Sites / Locations
- Sofiamed Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard 3 port TEP
LESS TEP
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 skin incision 2-3cm.
Outcomes
Primary Outcome Measures
Postoperative Pain
Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.
Postoperative Pain
Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.
Secondary Outcome Measures
Operating time
Intraoperative complications
Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage
Length of hospital stay
Postoperative complications
Urinary infections; Seroma; Hematoma
Recurrence of hernia
Cosmetic scar score
Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04303182
Brief Title
LESS TEP vs. Three Port TEP for Inguinal Hernia Repair
Official Title
Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sofia Med Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aim to compare efficacy and safety of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.
Detailed Description
This is a prospective, double blinded, randomized trial. It compared of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.
Inguinal hernia is one of the most common surgical diseases. Laparoscopic hernia repairs include two types, TEP and TAPP. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period and better cosmetic results. Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery.
200 patients will undergo TEP inguinal hernia repair. They will be randomized in two groups by sealed envelope method.
Group A: Standard TEP with 3 ports (10mm. and 2 ports of 5mm.). In case of difficulty in Standard 3 port TEP inguinal hernia repair, the procedure will be converted to TAPP.
Group B: LESS TEP with single skin incision 2-3cm. In case of difficulty in LESS TEP inguinal hernia repair, the procedure will be converted to standard 3 port repair or TAPP.
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
Inguinal Hernia
Keywords
TEP, LESS TEP, Inguinal Hernia, Laparoscopic Surgery, Recurrence inguinal hernia, Primary inguinal hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard 3 port 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
LESS TEP
Arm Type
Active Comparator
Arm Description
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
Intervention Type
Procedure
Intervention Name(s)
Standard 3 port TEP
Intervention Description
3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port
Intervention Type
Procedure
Intervention Name(s)
LESS TEP
Intervention Description
TEP inguinal hernia repair with one vertical skin incision under the umbilicus
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.
Time Frame
24hours
Title
Postoperative Pain
Description
Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Operating time
Time Frame
During operation
Title
Intraoperative complications
Description
Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage
Time Frame
During operation
Title
Length of hospital stay
Time Frame
24 hours
Title
Postoperative complications
Description
Urinary infections; Seroma; Hematoma
Time Frame
1 week; 4 weeks
Title
Recurrence of hernia
Time Frame
4 weeks; 3 months; 1 year
Title
Cosmetic scar score
Description
Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 90 years
Willing to participate in this study and signed an informed consent.
Diagnosed inguinal hernia - primary or recurrence
ASA class I, II and III
Exclusion Criteria:
Age under 18 years and above 90 years
Strangulated hernia
Patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia
Patients who prefer a certain surgical approach
Patients who undergo surgery procedures for chronic pain after inguinal hernia repair
Facility Information:
Facility Name
Sofiamed Hospital
City
Sofia
Country
Bulgaria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LESS TEP vs. Three Port TEP for Inguinal Hernia Repair
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