BIOLAP: Biological versus synthetic mesh in laparoscopic hernia repair-a randomized multicenter, prospective, self-controlled clinical trial

BIOLAP: Biological versus synthetic mesh in laparoscopic hernia repair-a randomized multicenter, prospective, self-controlled clinical trial - BIOLAP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010178

Enrollment

496

Registered

2016-06-16

Start date

2017-08-17

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

K40.2

Interventions

Group 1: Biological mesh in laparoscopic hernia repair for one of the bilateral hernias. Endoscopic hernia repair (TAPP or TEP) has to be performed as described in the “Guidelines for laparoscopic (TA

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female patient at an age of 18 years or older 2. Primary, bilateral hernias 3. Patient eligible for laparoscopic hernia repair 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Recurrent hernia 2. Incarcerated hernia 3. Presence of any acute systemic infection 4. Expected non-compliance with any study-related requirement

Design outcomes

Primary

Measure	Time frame
The unit of analysis is the hernia, not the patient. The study has two primary endpoints. 1. Incidence of postoperative local pain at the hernia site at six months after operation measured with a visual analogue scale (VAS 0-10) 2. Incidence of recurrent hernia within the first two years after operation The total duration of follow-up per patient will be 2 years. Intended trial visits: PRE = pre-operative assessment; OP = surgical procedure; F-1W, F-6M, F-12M, F-24M: clinical follow-up visit and assessment of endpoints at one week, six months, one year and two years after surgery. Scope of the follow-up visits: clinical examination, evaluation of pain (VAS on each side), complications, patient satisfaction, and recurrence. If a hernia recurrence was suspected, a verification with ultra-sound or MR or CT-scan will be performed.	—

Measure

Time frame

The unit of analysis is the hernia, not the patient. The study has two primary endpoints. 1. Incidence of postoperative local pain at the hernia site at six months after operation measured with a visual analogue scale (VAS 0-10) 2. Incidence of recurrent hernia within the first two years after operation The total duration of follow-up per patient will be 2 years. Intended trial visits: PRE = pre-operative assessment; OP = surgical procedure; F-1W, F-6M, F-12M, F-24M: clinical follow-up visit and assessment of endpoints at one week, six months, one year and two years after surgery. Scope of the follow-up visits: clinical examination, evaluation of pain (VAS on each side), complications, patient satisfaction, and recurrence. If a hernia recurrence was suspected, a verification with ultra-sound or MR or CT-scan will be performed.

—

Secondary

Measure	Time frame
-prevalence and intensity of local pain at other time points (one week and one year postoperatively) - early recurrences within the first year after surgery -wound infection -hematoma -seroma - patient satisfaction (overall results, foreign body sensation, paraesthesia) Intended trial visits: PRE = pre-operative assessment; OP = surgical procedure; F-1W, F-6M, F-12M, F-24M: clinical follow-up visit and assessment of endpoints at one week, six months, one year and two years after surgery. Scope of the follow-up visits: clinical examination, evaluation of pain (VAS on each side), complications, patient satisfaction, and recurrence. If a hernia recurrence was suspected, a verification with ultra-sound or MR or CT-scan will be performed.	—

Measure

Time frame

-prevalence and intensity of local pain at other time points (one week and one year postoperatively) - early recurrences within the first year after surgery -wound infection -hematoma -seroma - patient satisfaction (overall results, foreign body sensation, paraesthesia) Intended trial visits: PRE = pre-operative assessment; OP = surgical procedure; F-1W, F-6M, F-12M, F-24M: clinical follow-up visit and assessment of endpoints at one week, six months, one year and two years after surgery. Scope of the follow-up visits: clinical examination, evaluation of pain (VAS on each side), complications, patient satisfaction, and recurrence. If a hernia recurrence was suspected, a verification with ultra-sound or MR or CT-scan will be performed.

—

Countries

Germany

Contacts

Public ContactMarkus Maria Heiss

Klinikum der Universität Witten/Herdecke; Campus Merheim; Kliniken der Stadt Köln, Klinik für Viszeral-, Gefäß- und Transplantationschirurgie, Deutschland

HeissM@kliniken-koeln.de0049-221-89073770

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 22, 2026