CompletedNot Applicable

Bilateral Laparoscopic Repair of Groin Hernias With One Large Self-fixating Mesh (ProGripTM)

Belgium100 participantsStarted 2015-08

Plain-language summary

Investigation of a bilateral inguinal hernia repair using one large self-fixating mesh covering both groins. Health outcomes are assessed using different questionaires with focus on urinary symptoms (with ICIQ-MLUTS score), the recurrence rate, postoperative pain measurement, and Quality of Life assessment with EuraHS-QoL and chronic pain monitoring for 12 months.

Who can participate

Age range18 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients scheduled for primary bilateral inguinal hernia repair Exclusion Criteria: * recurrent groin hernia * open hernia repair * unilateral hernias * concomitant repair of another abdominal hernia e.g. umbilical hernia * hernia repair combined with another surgical procedure * emergency operations, like incarcerated hernias * patients under the age of 18 years or over 80 years * ASA score 4 or more * patients unable to perform the QoL assessment, because of language barrier or intellectual incapacity * no informed consent of the patient

What they're measuring

Assessment of ICIQ-MLUTS Score

Timeframe: 12 months

Trial details

NCT IDNCT02525666

SponsorAlgemeen Ziekenhuis Maria Middelares

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06-28

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