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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01201564
First received: July 19, 2010
Last updated: September 10, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 01, 2014