Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
Primary Purpose
Umbilical Hernia
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
intraperitoneal onlay mesh repair
sublay mesh repair
Sponsored by
About this trial
This is an interventional treatment trial for Umbilical Hernia focused on measuring umbilical hernia,, wound complications,, mesh repair, IPOM,, quality of life,, sublay mesh repair,, recurrence rate
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
Sites / Locations
- Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH
- University Hospital Basel
- Luzerner Kantonsspital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intraperitoneal onlay mesh repair
sublay mesh repair
Arm Description
Outcomes
Primary Outcome Measures
early wound complications
wound infection (with or without removal of the mesh)
wound necrosis
wound hematoma
late wound complications
wound infection (with or without removal of the mesh)
wound necrosis
wound hematoma
Secondary Outcome Measures
complication rate perioperative
major bleeding
bowel injury
duration of operation
measured in minutes according to operations protocol (duration cut - suture)
hospital stay
measured in days
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
umbilical hernia recurrence rate
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
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))
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))
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))
complication rate postoperative
trocar site hernia
enteral fistula
persistent pain
re-operation
complication rate postoperative
trocar site hernia
enteral fistula
persistent pain
re-operation
complication rate postoperative
trocar site hernia
enteral fistula
persistent pain
re-operation
complication rate postoperative
trocar site hernia
enteral fistula
persistent pain
re-operation
pain score (Visual Analog Scale - VAS)
will be measured by the nurse according to Visual Analog Scale
pain score (Visual Analog Scale - VAS)
will be measured by the nurse according to Visual Analog Scale
pain score (Visual Analog Scale - VAS)
will be measured by the nurse according to Visual Analog Scale
Quality of life (SF-36)
patients will be asked to fulfill validated SF-36 questionnaire
Quality of life (SF-36)
patients will be asked to fulfill validated SF-36 questionnaire
Quality of life (SF-36)
patients will be asked to fulfill validated SF-36 questionnaire
Full Information
NCT ID
NCT01201564
First Posted
July 19, 2010
Last Updated
May 6, 2019
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Clinical Trial Unit, University Hospital Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01201564
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruiting problems
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Clinical Trial Unit, University Hospital Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
Keywords
umbilical hernia,, wound complications,, mesh repair, IPOM,, quality of life,, sublay mesh repair,, recurrence rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intraperitoneal onlay mesh repair
Arm Type
Active Comparator
Arm Title
sublay mesh repair
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
intraperitoneal onlay mesh repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sublay mesh repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
early wound complications
Description
wound infection (with or without removal of the mesh)
wound necrosis
wound hematoma
Time Frame
30 days after operation
Title
late wound complications
Description
wound infection (with or without removal of the mesh)
wound necrosis
wound hematoma
Time Frame
1 year after operation
Secondary Outcome Measure Information:
Title
complication rate perioperative
Description
major bleeding
bowel injury
Time Frame
intraoperative complications will be recorded immediately after finishing the operation
Title
duration of operation
Description
measured in minutes according to operations protocol (duration cut - suture)
Time Frame
the duration will be recorded immediately after finishing the operation
Title
hospital stay
Description
measured in days
Time Frame
will be measured after discharge of the patient
Title
umbilical hernia recurrence rate
Description
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time Frame
30 days
Title
umbilical hernia recurrence rate
Description
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time Frame
1 year
Title
umbilical hernia recurrence rate
Description
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time Frame
3 years
Title
umbilical hernia recurrence rate
Description
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
Time Frame
5 years
Title
navel site seroma
Description
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))
Time Frame
discharge day
Title
navel site seroma
Description
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))
Time Frame
after 30 days
Title
navel site seroma
Description
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))
Time Frame
after 1 year
Title
complication rate postoperative
Description
trocar site hernia
enteral fistula
persistent pain
re-operation
Time Frame
30 day
Title
complication rate postoperative
Description
trocar site hernia
enteral fistula
persistent pain
re-operation
Time Frame
1 year
Title
complication rate postoperative
Description
trocar site hernia
enteral fistula
persistent pain
re-operation
Time Frame
3 years
Title
complication rate postoperative
Description
trocar site hernia
enteral fistula
persistent pain
re-operation
Time Frame
5 years
Title
pain score (Visual Analog Scale - VAS)
Description
will be measured by the nurse according to Visual Analog Scale
Time Frame
24h post operative
Title
pain score (Visual Analog Scale - VAS)
Description
will be measured by the nurse according to Visual Analog Scale
Time Frame
48h post operative
Title
pain score (Visual Analog Scale - VAS)
Description
will be measured by the nurse according to Visual Analog Scale
Time Frame
immediately before discharge
Title
Quality of life (SF-36)
Description
patients will be asked to fulfill validated SF-36 questionnaire
Time Frame
1 day pre-operative
Title
Quality of life (SF-36)
Description
patients will be asked to fulfill validated SF-36 questionnaire
Time Frame
30 days postoperatively
Title
Quality of life (SF-36)
Description
patients will be asked to fulfill validated SF-36 questionnaire
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Oertli, Professor
Organizational Affiliation
Departement of General Surgery, University Hospital Basel, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oleg Heizmann, MD
Organizational Affiliation
Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Matz, MD
Organizational Affiliation
Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH
City
Rotenburg
State/Province
Niedersachsen
ZIP/Postal Code
27356
Country
Germany
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18924044
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.
Results Reference
background
PubMed Identifier
14574545
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.
Results Reference
background
PubMed Identifier
17861015
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.
Results Reference
background
PubMed Identifier
10933738
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.
Results Reference
background
PubMed Identifier
19124962
Citation
Venclauskas L, Silanskaite J, Kiudelis M. Umbilical hernia: factors indicative of recurrence. Medicina (Kaunas). 2008;44(11):855-9.
Results Reference
background
PubMed Identifier
19015918
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.
Results Reference
background
PubMed Identifier
19591158
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.
Results Reference
background
PubMed Identifier
8975342
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.
Results Reference
background
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Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
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