Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01201564
Recruitment Status : Terminated (Recruiting problems)
First Posted : September 14, 2010
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE July 19, 2010
First Posted Date  ICMJE September 14, 2010
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • early wound complications [ Time Frame: 30 days after operation ]
    • wound infection (with or without removal of the mesh)
    • wound necrosis
    • wound hematoma
  • late wound complications [ Time Frame: 1 year after operation ]
    • wound infection (with or without removal of the mesh)
    • wound necrosis
    • wound hematoma
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01201564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • complication rate perioperative [ Time Frame: intraoperative complications will be recorded immediately after finishing the operation ]
    • major bleeding
    • bowel injury
  • duration of operation [ Time Frame: the duration will be recorded immediately after finishing the operation ]
    measured in minutes according to operations protocol (duration cut - suture)
  • hospital stay [ Time Frame: will be measured after discharge of the patient ]
    measured in days
  • umbilical hernia recurrence rate [ Time Frame: 30 days ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • umbilical hernia recurrence rate [ Time Frame: 1 year ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • umbilical hernia recurrence rate [ Time Frame: 3 years ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • umbilical hernia recurrence rate [ Time Frame: 5 years ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • 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))
  • 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))
  • 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))
  • complication rate postoperative [ Time Frame: 30 day ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation
  • complication rate postoperative [ Time Frame: 1 year ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation
  • complication rate postoperative [ Time Frame: 3 years ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation
  • complication rate postoperative [ Time Frame: 5 years ]
    • trocar site hernia
    • enteral fistula
    • persistent pain
    • re-operation
  • pain score (Visual Analog Scale - VAS) [ Time Frame: 24h post operative ]
    will be measured by the nurse according to Visual Analog Scale
  • pain score (Visual Analog Scale - VAS) [ Time Frame: 48h post operative ]
    will be measured by the nurse according to Visual Analog Scale
  • pain score (Visual Analog Scale - VAS) [ Time Frame: immediately before discharge ]
    will be measured by the nurse according to Visual Analog Scale
  • Quality of life (SF-36) [ Time Frame: 1 day pre-operative ]
    patients will be asked to fulfill validated SF-36 questionnaire
  • Quality of life (SF-36) [ Time Frame: 30 days postoperatively ]
    patients will be asked to fulfill validated SF-36 questionnaire
  • Quality of life (SF-36) [ Time Frame: 1 year postoperatively ]
    patients will be asked to fulfill validated SF-36 questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • complication rate perioperative [ Time Frame: intraoperative complications will be recorded immediatly after finishing the operation ]
    • major bleeding
    • bowel injury
  • 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)
  • hospital stay [ Time Frame: will be measured after discharge of the patient ]
    measured in days
  • umbilical hernia recurrence rate [ Time Frame: 30 days ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • umbilical hernia recurrence rate [ Time Frame: 1 year ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • umbilical hernia recurrence rate [ Time Frame: 3 years ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • umbilical hernia recurrence rate [ Time Frame: 5 years ]
    the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
  • 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 breatdth(cm)x lenghth(cm))
  • 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 breatdth(cm)x lenghth(cm))
  • 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 breatdth(cm)x lenghth(cm))
  • complication rate postoperative [ Time Frame: 30 day ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • complication rate postoperative [ Time Frame: 1 year ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • complication rate postoperative [ Time Frame: 3 years ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • complication rate postoperative [ Time Frame: 5 years ]
    • trokar site hernia
    • enteral fistula
    • persistant pain
    • re-operation
  • pain score (Visual Analog Scale - VAS) [ Time Frame: 24h post operative ]
    will be measured by the nurse according to Visual Analog Scale
  • pain score (Visual Analog Scale - VAS) [ Time Frame: 48h post operative ]
    will be measured by the nurse according to Visual Analog Scale
  • pain score (Visual Analog Scale - VAS) [ Time Frame: immediately before discharge ]
    will be measured by the nurse according to Visual Analog Scale
  • Quality of life (SF-36) [ Time Frame: 1 day pre-operative ]
    patients will be asked to fulfill validated SF-36 questionnaire
  • Quality of life (SF-36) [ Time Frame: 30 days postoperatively ]
    patients will be asked to fulfill validated SF-36 questionnaire
  • Quality of life (SF-36) [ Time Frame: 1 year postoperatively ]
    patients will be asked to fulfill validated SF-36 questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
Official Title  ICMJE Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Umbilical Hernia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: intraperitoneal onlay mesh repair
    Intervention: Procedure: intraperitoneal onlay mesh repair
  • Active Comparator: sublay mesh repair
    Intervention: Procedure: sublay mesh repair
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 13, 2010)
306
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries China,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01201564
Other Study ID Numbers  ICMJE IPOM-46/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators  ICMJE
Study Chair: Daniel Oertli, Professor Departement of General 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
PRS Account University Hospital, Basel, Switzerland
Verification Date May 2019

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