Study comparing single-incision laparoscopy versus multitrocar laparoscopy totally extraperitoneal inguinal hernia repair (TEP) at 2 years

Prospective randomised study comparing single-incision laparoscopy versus multitrocar laparoscopy totally extraperitoneal inguinal hernia repair (TEP) at 2 years

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63754528

Enrollment

210

Registered

2017-08-17

Start date

2013-01-14

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral or bilateral inguinal hernia requiring surgical treatment Injury, Occupational Diseases, Poisoning Unilateral or bilateral inguinal hernia

Interventions

Participants are randomised using computer-generated randomized numbers in sealed envelopes to either: Single-incision laparoscopy totally extraperitoneal (SILTEP) inguinal hernia repair: A 1.5 cm um

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (aged 18 years or over) 2. Unilateral or bilateral inguinal hernia 3. Patient’s approval

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Patient refusal to partecipate in the study 3. Inability to receive general anesthesia 4. Concomitant surgical procedures out of hernia repair

Design outcomes

Primary

Measure	Time frame
Mid-term outcomes: 1. Late postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma (no case reported), umbilical infection (no case reported), testicular atrophy and chronic pain reported by each patient at follow-up (after 30 days from surgery and during interview) 2. Late inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at follow-up (after 30 days from surgery and during interview) 3. Surgical satisfaction, measured using a numerical rating scale (NRS) at follow-up (during interview) 4. Cosmetic satisfaction, measured using a score questionnaire at follow-up (during interview)	—

Measure

Time frame

Mid-term outcomes: 1. Late postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma (no case reported), umbilical infection (no case reported), testicular atrophy and chronic pain reported by each patient at follow-up (after 30 days from surgery and during interview) 2. Late inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at follow-up (after 30 days from surgery and during interview) 3. Surgical satisfaction, measured using a numerical rating scale (NRS) at follow-up (during interview) 4. Cosmetic satisfaction, measured using a score questionnaire at follow-up (during interview)

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Secondary

Measure	Time frame
1. Perioperative outcomes: 1.1. Operative time, calculated using the time from the skin incision until fascia closure at the end of surgical procedure 1.2. Mesh fixation, measured using the number of tack devices used to fix the mesh (if it was necessary) at the end of surgical procedure. (one tack device was used for each mesh fixed) 1.3. Operative complications, measured using the number of peritoneal tear repair, epigastric vessels injury, corona mortis bleeding and conversion to TAPP (transabdominal preperitoneal) repair during surgical procedure 1.4. Postoperative pain, assessed using a visual analogue scale (VAS) at 6, 12, 18 and 24 hours after surgery 1.5. Hospital stay, measured using the number of days of patient’s hospitalization 2. Short-term outcomes: 2.1. Early postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma, umbilical infection (abscess), urinary retention and testicular atrophy at office consultation on 7 and 30 days from surgery 2.2. Early inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at office consultation on 7 and 30 days from surgery 2.3. Days to return to activity daily living (ADL), measured using the number of days necessary to return to ADL for each patient evaluated at consultation on 7 and 30 days from surgery or during the interview	—

Measure

Time frame

1. Perioperative outcomes: 1.1. Operative time, calculated using the time from the skin incision until fascia closure at the end of surgical procedure 1.2. Mesh fixation, measured using the number of tack devices used to fix the mesh (if it was necessary) at the end of surgical procedure. (one tack device was used for each mesh fixed) 1.3. Operative complications, measured using the number of peritoneal tear repair, epigastric vessels injury, corona mortis bleeding and conversion to TAPP (transabdominal preperitoneal) repair during surgical procedure 1.4. Postoperative pain, assessed using a visual analogue scale (VAS) at 6, 12, 18 and 24 hours after surgery 1.5. Hospital stay, measured using the number of days of patient’s hospitalization 2. Short-term outcomes: 2.1. Early postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma, umbilical infection (abscess), urinary retention and testicular atrophy at office consultation on 7 and 30 days from surgery 2.2. Early inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at office consultation on 7 and 30 days from surgery 2.3. Days to return to activity daily living (ADL), measured using the number of days necessary to return to ADL for each patient evaluated at consultation on 7 and 30 days from surgery or during the interview

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Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026