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Umbilical HerniaPhase 4NCT01201564

Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

A Phase 4 study testing intraperitoneal onlay mesh repair and sublay mesh repair in people with Umbilical Hernia, run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Umbilical Hernia
What is being tested?
intraperitoneal onlay mesh repair and sublay mesh repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
3 sitesin 2 countries
Study dates
Jul 2010to Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • informed consent
  • patient age: ≥ 18 years
  • elective surgery for umbilical hernia
  • hernia diameter ≥ 1cm

Who cannot join

  • previous history of median laparotomy
  • navel site infection
  • contraindication for general anaesthesia
  • American Society of Anesthesiologists (ASA) score >IV
  • pregnancy
  • cirrhosis of the liver (CHILD B and C) and/or ascites
Show all 9Show fewer
  • cytostatic therapy
  • incarcerated hernia
  • recurrent hernia

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Switzerland2 sites

  • University Hospital Basel

    Basel, 4031

  • Luzerner Kantonsspital

    Lucerne, 6000

Other trials in Switzerland

Germany1 site

  • Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH

    Rotenburg (Wümme), Lower Saxony, 27356

Other trials in Germany

About this study

Official title: Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.

Being tested
intraperitoneal onlay mesh repair, sublay mesh repair
Keywords
umbilical hernia,, wound complications,, mesh repair, IPOM,, quality of life,, sublay mesh repair,, recurrence rate
Medical subject headings
Hernia, Umbilical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intraperitoneal onlay mesh repairProcedure or surgery

    The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.

  • sublay mesh repairProcedure or surgery

    The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.

Study groups in NCT01201564
Study groupRoleWhat they receive
intraperitoneal onlay mesh repairActive comparatorNot described
Receives: Procedure: intraperitoneal onlay mesh repair
sublay mesh repairActive comparatorNot described
Receives: Procedure: sublay mesh repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. early wound complications

    • wound infection (with or without removal of the mesh)
    • wound necrosis
    • wound hematoma

    Measured: 30 days after operation

  2. late wound complications

    • wound infection (with or without removal of the mesh)
    • wound necrosis
    • wound hematoma

    Measured: 1 year after operation

Secondary outcomes (20)

  1. complication rate perioperative

    • major bleeding
    • bowel injury

    Measured: intraoperative complications will be recorded immediately after finishing the operation

  2. duration of operation

    measured in minutes according to operations protocol (duration cut - suture)

    Measured: the duration will be recorded immediately after finishing the operation

  3. hospital stay

    measured in days

    Measured: will be measured after discharge of the patient

  4. umbilical hernia recurrence rate

    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

    Measured: 30 days

  5. umbilical hernia recurrence rate

    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

    Measured: 1 year

  6. umbilical hernia recurrence rate

    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

    Measured: 3 years

  7. umbilical hernia recurrence rate

    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

    Measured: 5 years

  8. navel site seroma

    the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))

    Measured: discharge day

  9. navel site seroma

    the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))

    Measured: after 30 days

  10. navel site seroma

    the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))

    Measured: after 1 year

  11. complication rate postoperative

    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

    Measured: 30 day

  12. complication rate postoperative

    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

    Measured: 1 year

  13. complication rate postoperative

    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

    Measured: 3 years

  14. complication rate postoperative

    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

    Measured: 5 years

  15. pain score (Visual Analog Scale - VAS)

    will be measured by the nurse according to Visual Analog Scale

    Measured: 24h post operative

  16. pain score (Visual Analog Scale - VAS)

    will be measured by the nurse according to Visual Analog Scale

    Measured: 48h post operative

  17. pain score (Visual Analog Scale - VAS)

    will be measured by the nurse according to Visual Analog Scale

    Measured: immediately before discharge

  18. Quality of life (SF-36)

    patients will be asked to fulfill validated SF-36 questionnaire

    Measured: 1 day pre-operative

  19. Quality of life (SF-36)

    patients will be asked to fulfill validated SF-36 questionnaire

    Measured: 30 days postoperatively

  20. Quality of life (SF-36)

    patients will be asked to fulfill validated SF-36 questionnaire

    Measured: 1 year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionDec 2018
  4. Study completionDec 2018

Why it stopped: Recruiting problems

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01201564
Sponsor's protocol ID
IPOM-46/10
Status last verified
May 2019
First submitted
19 Jul 2010
Last updated
7 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Benhidjeb T, Benecke C, Strik MW. [Incisional hernia repair: sublay or intraperitoneal onlay mesh (IPOM)?]. Zentralbl Chir. 2008 Sep;133(5):458-63. doi: 10.1055/s-2008-1076954. Epub 2008 Oct 15. German.

    PubMed 18924044

  • Lau H, Patil NG. Umbilical hernia in adults. Surg Endosc. 2003 Dec;17(12):2016-20. doi: 10.1007/s00464-003-9027-7. Epub 2003 Oct 28.

    PubMed 14574545

  • Mayo WJ. VI. An Operation for the Radical Cure of Umbilical Hernia. Ann Surg. 1901 Aug;34(2):276-80. doi: 10.1097/00000658-190107000-00021. No abstract available.

    PubMed 17861015

  • Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN, Boelhouwer RU, de Vries BC, Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000 Aug 10;343(6):392-8. doi: 10.1056/NEJM200008103430603.

    PubMed 10933738

  • Venclauskas L, Silanskaite J, Kiudelis M. Umbilical hernia: factors indicative of recurrence. Medicina (Kaunas). 2008;44(11):855-9.

    PubMed 19124962

  • Hilling DE, Koppert LB, Keijzer R, Stassen LP, Oei IH. Laparoscopic correction of umbilical hernias using a transabdominal preperitoneal approach: results of a pilot study. Surg Endosc. 2009 Aug;23(8):1740-4. doi: 10.1007/s00464-008-0177-5. Epub 2008 Nov 18.

    PubMed 19015918

  • Forbes SS, Eskicioglu C, McLeod RS, Okrainec A. Meta-analysis of randomized controlled trials comparing open and laparoscopic ventral and incisional hernia repair with mesh. Br J Surg. 2009 Aug;96(8):851-8. doi: 10.1002/bjs.6668.

    PubMed 19591158

  • Bullinger M. [Assessment of health related quality of life with the SF-36 Health Survey]. Rehabilitation (Stuttg). 1996 Aug;35(3):XVII-XXVII; quiz XXVII-XXIX. German.

    PubMed 8975342

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing intraperitoneal onlay mesh repair and sublay mesh repair in people with Umbilical Hernia, run by University Hospital, Basel, Switzerland at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

early wound complications (time frame: 30 days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01201564, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.

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