Clinical trial NCT01201564: Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
Official title: Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Umbilical Hernia
Keywords: umbilical hernia,
wound complications,
mesh repair, IPOM,
quality of life,
sublay mesh repair,
recurrence rate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2010-09-14
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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
* American Society of Anesthesiologists (ASA) score \>IV
* pregnancy
* cirrhosis of the liver (CHILD B and C) and/or ascites
* cytostatic therapy
* incarcerated hernia
* recurrent hernia

Primary outcomes:
measure: early wound complications
timeFrame: 30 days after operation
measure: late wound complications
timeFrame: 1 year after operation
Secondary outcomes:
measure: complication rate perioperative
timeFrame: intraoperative complications will be recorded immediately after finishing the operation
measure: duration of operation
timeFrame: the duration will be recorded immediately after finishing the operation
measure: hospital stay
timeFrame: will be measured after discharge of the patient
measure: umbilical hernia recurrence rate
timeFrame: 30 days
measure: umbilical hernia recurrence rate
timeFrame: 1 year
measure: umbilical hernia recurrence rate
timeFrame: 3 years
measure: umbilical hernia recurrence rate
timeFrame: 5 years
measure: navel site seroma
timeFrame: discharge day
measure: navel site seroma
timeFrame: after 30 days
measure: navel site seroma
timeFrame: after 1 year
measure: complication rate postoperative
timeFrame: 30 day
measure: complication rate postoperative
timeFrame: 1 year
measure: complication rate postoperative
timeFrame: 3 years
measure: complication rate postoperative
timeFrame: 5 years
measure: pain score (Visual Analog Scale - VAS)
timeFrame: 24h post operative
measure: pain score (Visual Analog Scale - VAS)
timeFrame: 48h post operative
measure: pain score (Visual Analog Scale - VAS)
timeFrame: immediately before discharge
measure: Quality of life (SF-36)
timeFrame: 1 day pre-operative
measure: Quality of life (SF-36)
timeFrame: 30 days postoperatively
measure: Quality of life (SF-36)
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Rotenburg
country: Germany
facility: Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH
state: Niedersachsen
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Departement of General Surgery, University Hospital Basel, Switzerland
name: Daniel Oertli, Professor
role: STUDY_CHAIR
affiliation: Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany
name: Oleg Heizmann, MD
role: STUDY_DIRECTOR
affiliation: Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany
name: Daniel Matz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Venclauskas L, Silanskaite J, Kiudelis M. Umbilical hernia: factors indicative of recurrence. Medicina (Kaunas). 2008;44(11):855-9.
citation: 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.
citation: 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.
citation: 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.