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

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ClinicalTrials.gov Identifier: NCT01201564
Recruitment Status : Recruiting
First Posted : September 14, 2010
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Umbilical Hernia Procedure: intraperitoneal onlay mesh repair Procedure: sublay mesh repair Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults
Study Start Date : July 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. early wound complications [ Time Frame: 30 days after operation ]
    • wound infection (with or without removal of the mesh)
    • wound necrosis
    • wound hematoma

  2. late wound complications [ Time Frame: 1 year after operation ]
    • wound infection (with or without removal of the mesh)
    • wound necrosis
    • wound hematoma


Secondary Outcome Measures :
  1. complication rate perioperative [ Time Frame: intraoperative complications will be recorded immediatly after finishing the operation ]
    • major bleeding
    • bowel injury

  2. duration of operation [ Time Frame: the duration will be recorded immediatly after finishing the operation ]
    measured in minutes according to operations protocol (duration cut - suture)

  3. hospital stay [ Time Frame: will be measured after discharge of the patient ]
    measured in days

  4. umbilical hernia recurrence rate [ Time Frame: 30 days ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

  5. umbilical hernia recurrence rate [ Time Frame: 1 year ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

  6. umbilical hernia recurrence rate [ Time Frame: 3 years ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

  7. umbilical hernia recurrence rate [ Time Frame: 5 years ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan

  8. navel site seroma [ Time Frame: discharge day ]
    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))

  9. navel site seroma [ Time Frame: after 30 days ]
    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))

  10. navel site seroma [ Time Frame: after 1 year ]
    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))

  11. complication rate postoperative [ Time Frame: 30 day ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

  12. complication rate postoperative [ Time Frame: 1 year ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

  13. complication rate postoperative [ Time Frame: 3 years ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

  14. complication rate postoperative [ Time Frame: 5 years ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation

  15. pain score (Visual Analog Scale - VAS) [ Time Frame: 24h post operative ]
    will be measured by the nurse according to Visual Analog Scale

  16. pain score (Visual Analog Scale - VAS) [ Time Frame: 48h post operative ]
    will be measured by the nurse according to Visual Analog Scale

  17. pain score (Visual Analog Scale - VAS) [ Time Frame: immediately before discharge ]
    will be measured by the nurse according to Visual Analog Scale

  18. Quality of life (SF-36) [ Time Frame: 1 day pre-operative ]
    patients will be asked to fulfill validated SF-36 questionnaire

  19. Quality of life (SF-36) [ Time Frame: 30 days postoperatively ]
    patients will be asked to fulfill validated SF-36 questionnaire

  20. Quality of life (SF-36) [ Time Frame: 1 year postoperatively ]
    patients will be asked to fulfill validated SF-36 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201564


Contacts
Contact: Daniel Oertli, Professor +41 61 265 ext 7234 daniel.oertli@usb.ch
Contact: Heizmann Oleg, MD +49 4261 77 ext 2691 o.heizmann@diako-online.de

Locations
China
West China Hospital of Sichuan University Not yet recruiting
ChengDu, China, 610041
Contact: Wang Yong, MD, PHD    +8613715102746    wydoctor1974@aliyun.com   
Germany
Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH 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         
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: Hoffmann 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

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01201564     History of Changes
Other Study ID Numbers: IPOM-46/10
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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