NCT02525666

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

August 5, 2015

Last Update Submit

July 13, 2018

Conditions

HerniaRecurrenceQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Assessment of ICIQ-MLUTS Score

    Assessment of urinary symptoms with the ICIQ\_MLUTS score at 12 month after laparoscopic repair of bilateral inguinal hernia

    12 months

Secondary Outcomes (2)

  • Assessment of ICIQ-MLUTS Score

    preoperative, 1 month and 3 month post-operative

  • Quality of Life assessment

    pre-operatively, 1, 3 and 12 month postoperatively

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 adult patients, men only, ages between 18 and 80 years with a primary bilateral inguinal hernias will be included based on clinical examination and/or ultrasonography.

You may qualify if:

  • patients scheduled for primary bilateral inguinal hernia repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Related Publications (5)

  • Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.

    PMID: 19636493BACKGROUND

  • Poelman MM, van den Heuvel B, Deelder JD, Abis GS, Beudeker N, Bittner RR, Campanelli G, van Dam D, Dwars BJ, Eker HH, Fingerhut A, Khatkov I, Koeckerling F, Kukleta JF, Miserez M, Montgomery A, Munoz Brands RM, Morales Conde S, Muysoms FE, Soltes M, Tromp W, Yavuz Y, Bonjer HJ. EAES Consensus Development Conference on endoscopic repair of groin hernias. Surg Endosc. 2013 Oct;27(10):3505-19. doi: 10.1007/s00464-013-3001-9. Epub 2013 May 25. No abstract available.

    PMID: 23708718BACKGROUND

  • Tam KW, Liang HH, Chai CY. Outcomes of staple fixation of mesh versus nonfixation in laparoscopic total extraperitoneal inguinal repair: a meta-analysis of randomized controlled trials. World J Surg. 2010 Dec;34(12):3065-74. doi: 10.1007/s00268-010-0760-5.

    PMID: 20714896BACKGROUND

  • Donovan JL, Peters TJ, Abrams P, Brookes ST, de aa Rosette JJ, Schafer W. Scoring the short form ICSmaleSF questionnaire. International Continence Society. J Urol. 2000 Dec;164(6):1948-55.

    PMID: 11061889BACKGROUND

  • Muysoms F, Dewulf M, Kyle-Leinhase I, Baumgartner R, Ameye F, Defoort B, Pletinckx P. Laparoscopic bilateral groin hernia repair with one large self-fixating mesh: prospective observational study with patient-reported outcome of urological symptoms and EuraHS-QoL scores. Surg Endosc. 2020 Feb;34(2):920-929. doi: 10.1007/s00464-019-06850-7. Epub 2019 May 28.

    PMID: 31139996DERIVED

MeSH Terms

Conditions

HerniaRecurrence

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Filip Muysoms, MD

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Surgery

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 17, 2015

Study Start

August 1, 2015

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations

BE(1)