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

This study is currently recruiting participants.
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

July 19, 2010
September 10, 2012
July 2010
July 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01201564 on ClinicalTrials.gov Archive Site
  • 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
  • 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 breatdth(cm)x lenghth(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 breatdth(cm)x lenghth(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 breatdth(cm)x lenghth(cm))
  • complication rate postoperative [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • complication rate postoperative [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • complication rate postoperative [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • complication rate postoperative [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    • trokar site hernia
    • enteral fistula
    • persistant 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
Not Provided
Not Provided
 
Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Umbilical Hernia
  • 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.
  • 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.
  • Active Comparator: intraperitoneal onlay mesh repair
    Intervention: Procedure: intraperitoneal onlay mesh repair
  • Active Comparator: sublay mesh repair
    Intervention: Procedure: sublay mesh repair

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
306
Not Provided
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Daniel Oertli, Professor +41 61 265 ext 7234 doertli@uhbs.ch
Contact: Heizmann Oleg, MD +41 61 328 ext 6867 oheizmann@uhbs.ch
Germany,   Poland,   Switzerland
 
NCT01201564
IPOM-46/10
No
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
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
University Hospital, Basel, Switzerland
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP