Inguinal hernia repair by totally extraperitoneal (TEP) approach - a randomised controlled trial comparing standard and mini-instruments

Inguinal hernia repair by totally extraperitoneal (TEP) approach - a randomised controlled trial comparing standard and mini-instruments - Mini-TEP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000602

Enrollment

120

Registered

2010-11-02

Start date

2010-09-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

K40.9 K40.2

Interventions

Group 1: Inguinal hernia repair in totally extraperitoneal (TEP) technique using miniaturized instruments (optical trocar 10mm, both working trocars 3mm) Group 2: Inguinal hernia repair in totally ext

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Uni- or bilateral primary or recurrent inguinal hernia; indication of surgical repair; age = 18 years; legal competence

Exclusion criteria

Exclusion criteria: Scrotal hernia; irreponible, incarcerated hernia; previous inguinal hernia repair by minimally-invasive approach (TEP or TAPP); previous laparotomy of the lower abdomen (excluding appendectomy); planned additional operation (excluding repair of contralateral hernia); body mass index (BMI) > 35 kg/m2; severe comorbidity (ASA IV or V); allergy or intolerance for paracetamol, dipidolor, or polypropylene; chronic alcohol or analgesics abuse; neuromuscular disease; pregancy or lactation; relationship of dependence concerning study staff; imprisonment or committment to an institution; participation in another interfering trial; previous participation in the present trial (for bilateral hernia); lack of written informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the trial is the level of postoperative pain during the first 7 postoperative days. The intensity of pain in the abdominal area will be measured during movement or coughing by using the visual analogue scale (VAS). Blinded with regard to group assignment, patients will record their level of pain in the range between 0 (no pain) and 100 (worst imaginable pain). In total, 7 VAS values will be recorded from postoperative day 1 to 7, which means that pain on the day of surgery itself is not part of the primary endpoint.	—

Measure

Time frame

The primary endpoint of the trial is the level of postoperative pain during the first 7 postoperative days. The intensity of pain in the abdominal area will be measured during movement or coughing by using the visual analogue scale (VAS). Blinded with regard to group assignment, patients will record their level of pain in the range between 0 (no pain) and 100 (worst imaginable pain). In total, 7 VAS values will be recorded from postoperative day 1 to 7, which means that pain on the day of surgery itself is not part of the primary endpoint.

—

Secondary

Measure	Time frame
Analgesic consumption exceeding the standard regimen (recorded from 1st to 7th postoperative day); duration of surgery; incidence of local complications, such as hematoma, seroma or nerve lesion (recorded from surgery until 7th postoperative day); patient satisfaction with cosmetic result (0-to-5 scale, assessed on 7th day and after 3 and 6 months); length of hospital stay; incidence and severity of chronic pain (after 3 and 6 months, measured on Short-Form McGill Pain Questionnaire-2)	—

Measure

Time frame

Analgesic consumption exceeding the standard regimen (recorded from 1st to 7th postoperative day); duration of surgery; incidence of local complications, such as hematoma, seroma or nerve lesion (recorded from surgery until 7th postoperative day); patient satisfaction with cosmetic result (0-to-5 scale, assessed on 7th day and after 3 and 6 months); length of hospital stay; incidence and severity of chronic pain (after 3 and 6 months, measured on Short-Form McGill Pain Questionnaire-2)

—

Countries

Germany

Contacts

Public ContactCarsten Martin

Klinik für Viszeral-, Thorax- und Gefäßchirurgie, Kreiskrankenhaus Gummersbach GmbH

Carsten.Martin@kkh-gummersbach.de02261171581

Outcome results

None listed

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