Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Umbilical Hernia	Procedure: intraperitoneal onlay mesh repair Procedure: sublay mesh repair	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

early wound complications [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
- wound infection (with or without removal of the mesh)
- wound necrosis
- wound hematoma
late wound complications [ Time Frame: 1 year after operation ] [ Designated as safety issue: No ]
- wound infection (with or without removal of the mesh)
- wound necrosis
- wound hematoma

Secondary Outcome Measures:

complication rate perioperative [ Time Frame: intraoperative complications will be recorded immediatly after finishing the operation ] [ Designated as safety issue: No ]
- major bleeding
- bowel injury
duration of operation [ Time Frame: the duration will be recorded immediatly after finishing the operation ] [ Designated as safety issue: No ]
measured in minutes according to operations protocol (duration cut - suture)
hospital stay [ Time Frame: will be measured after discharge of the patient ] [ Designated as safety issue: No ]
measured in days
umbilical hernia recurrence rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
umbilical hernia recurrence rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
umbilical hernia recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
umbilical hernia recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
navel site seroma [ Time Frame: discharge day ] [ Designated as safety issue: No ]
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))
navel site seroma [ Time Frame: after 30 days ] [ Designated as safety issue: No ]
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))
navel site seroma [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
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))
complication rate postoperative [ Time Frame: 30 day ] [ Designated as safety issue: No ]
- trocar site hernia
- enteral fistula
- persistent pain
- re-operation
complication rate postoperative [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- trocar site hernia
- enteral fistula
- persistent pain
- re-operation
complication rate postoperative [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- trocar site hernia
- enteral fistula
- persistent pain
- re-operation
complication rate postoperative [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- trocar site hernia
- enteral fistula
- persistent pain
- re-operation
pain score (Visual Analog Scale - VAS) [ Time Frame: 24h post operative ] [ Designated as safety issue: No ]
will be measured by the nurse according to Visual Analog Scale
pain score (Visual Analog Scale - VAS) [ Time Frame: 48h post operative ] [ Designated as safety issue: No ]
will be measured by the nurse according to Visual Analog Scale
pain score (Visual Analog Scale - VAS) [ Time Frame: immediately before discharge ] [ Designated as safety issue: No ]
will be measured by the nurse according to Visual Analog Scale
Quality of life (SF-36) [ Time Frame: 1 day pre-operative ] [ Designated as safety issue: No ]
patients will be asked to fulfill validated SF-36 questionnaire
Quality of life (SF-36) [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
patients will be asked to fulfill validated SF-36 questionnaire
Quality of life (SF-36) [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
patients will be asked to fulfill validated SF-36 questionnaire

Estimated Enrollment:	306
Study Start Date:	July 2010
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: intraperitoneal onlay mesh repair	Procedure: intraperitoneal onlay mesh repair 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.
Active Comparator: sublay mesh repair	Procedure: sublay mesh repair 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201564

Contacts

Contact: Daniel Oertli, Professor	+41 61 265 ext 7234	doertli@uhbs.ch
Contact: Heizmann Oleg, MD	+41 61 328 ext 6867	oheizmann@uhbs.ch

Locations

Germany
Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH	Not yet recruiting
Rotenburg, Niedersachsen, Germany, 27356
Contact: Oleg Heizmann, MD +49 4261 77 ext 2691 o.heizmann@diako-online.de
Contact: Daniel Matz, MD +49 4261 77 ext 2691 d.matz@diako-online.de
Principal Investigator: Daniel Matz, MD
Principal Investigator: Oleg Heizmann, MD
Poland
Jagiellonian University	Recruiting
Cracow, Poland, 31-501
Contact: Miroslaw Szura, MD, PhD msszura@gmail.com
Contact: Radoslaw Pach, MD, PhD radoslaw.pach@uj.edu.pl
Sub-Investigator: Radoslaw Pach, MD. PhD
Switzerland
University Hospital Basel	Recruiting
Basel, Switzerland, 4031
Contact: Daniel Oertli, Professor +41 61 265 ext 7234 doertli@uhbs.ch
Contact: Henry Hoffmann, MD +41 61 328 ext 7824 hhoffmann@uhbs.ch
Sub-Investigator: Hofmann Henry, MD
Luzerner Kantonsspital	Recruiting
Luzern, Switzerland, 6000
Contact: Jürg Metzger, Professor +41 205 ext 48 62 juerg.metzger@ksl.ch
Contact: Melanie Kauper, MD +41 205 ext 48 62 melanie.kauper@ksl.ch
Principal Investigator: Melanie Kauper, MD
Sub-Investigator: Angela Lemarechal, MD

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

Study Chair:	Daniel Oertli, Professor	Departement of Genral Surgery, University Hospital Basel, Switzerland
Study Director:	Oleg Heizmann, MD	Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany
Principal Investigator:	Daniel Matz, MD	Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

More Information

Publications:

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

Lau H, Patil NG. Umbilical hernia in adults. Surg Endosc. 2003 Dec;17(12):2016-20. Epub 2003 Oct 28. Review.

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

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.

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

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. Epub 2008 Nov 18.

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. Review.

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.

Responsible Party:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT01201564 History of Changes
Other Study ID Numbers:	IPOM-46/10
Study First Received:	July 19, 2010
Last Updated:	September 10, 2012
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:

umbilical hernia,
wound complications,
mesh repair, IPOM,

quality of life,
sublay mesh repair,
recurrence rate

Additional relevant MeSH terms:

Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical

Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 17, 2013