Inguinal Hernia
Conditions
Keywords
TEP, LESS TEP, Inguinal Hernia, Laparoscopic Surgery, Recurrence inguinal hernia, Primary inguinal hernia
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.
Interventions
PROCEDUREStandard 3 port TEP
3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port
PROCEDURELESS TEP
TEP inguinal hernia repair with one vertical skin incision under the umbilicus
Sponsors
Sofia Med Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 24hours | Postoperative pain will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain intensity (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Time | During operation | Operative time will be measured as the duration of the surgical procedure using time in minutes. The measurement starts from skin incision and ends at completion of skin closure. The scale ranges from 0 to no predefined maximum value, with higher values indicating longer operative duration (worse outcome in terms of efficiency). |
| Intraoperative Complications | During operation | Number of participants with intraoperative complications, defined as any unintended injury occurring during surgery, including spermatic cord injury (vas deferens), vascular injury, or injury to adjacent organs (e.g., bladder, bowel). The outcome is reported as a count (number of participants), with a range from 0 to total number of participants. Higher values indicate worse outcome (greater complication rate). |
| Length of Hospital Stay | From end of surgery until hospital discharge (typically within 1-3 days postoperatively). | Length of hospital stay will be measured as the time in days from completion of surgery to hospital discharge. The outcome is reported as a continuous variable (days), with values ranging from 0 to no predefined maximum. Higher values indicate longer hospitalization (worse outcome in terms of recovery efficiency). |
| Postoperative Complications | Within 4 weeks postoperatively. | Number of participants with postoperative complications, defined as the occurrence of urinary tract infection, seroma, or hematoma within the postoperative period. The outcome is reported as a cumulative count of participants experiencing at least one complication within 4 weeks after surgery. The range is from 0 to total number of participants, with higher values indicating worse outcome (higher complication rate). |
| Recurrence of Hernia | During the entire follow-up period (up to 2 years) | Number of participants with hernia recurrence, defined as a clinically or radiologically confirmed reappearance of an inguinal hernia at the site of previous repair Hernia recurrence was assessed throughout the follow-up period. The reported value represents the cumulative number of recurrences observed during follow-up of up to 2 years. |
| Patient Satisfaction | 1 year | Patient satisfaction with the cosmetic result will be assessed using a numeric rating scale (NRS) ranging from 1 to 10, where 1 indicates not satisfied at all and 10 indicates very satisfied. Higher scores represent better outcome (greater patient satisfaction). |
Countries
Bulgaria
Participant flow
Recruitment details
Participants were prospectively recruited at the Department of Surgery, University Hospital "Sofiamed", Sofia, Bulgaria, between January and October 2020. Adult patients with unilateral or bilateral inguinal hernia scheduled for elective surgery were screened during outpatient visits or hospital admission. Eligibility was assessed after standard preoperative evaluation. Written informed consent was obtained prior to enrollment. A total of 200 patients were randomized 1:1 to LESS-TEP or standard.
Pre-assignment details
Before randomization, all patients underwent standard preoperative assessment, including medical history, physical examination, laboratory testing, and anesthesiology evaluation. Eligibility was confirmed according to predefined inclusion and exclusion criteria. Written informed consent was obtained from all participants prior to allocation. Only eligible and consented patients were randomized to the intervention groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants |
| Age, Continuous | 49.9 year STANDARD_DEVIATION 15.7 |
| ASA class | 2.0 units on a scale STANDARD_DEVIATION 0.75 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
None listed