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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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 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:

  • 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


Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: July 19, 2010
Date Started: July 2010
Date Completion: December 2018
Last Updated: January 5, 2017
Last Verified: January 2017