Umbilical hernias can be found in over a quarter of the population and comprise of 15% of hernia repairs performed in Canada. While mesh repair is commonly used for larger hernias, smaller hernia defects are often closed with sutures alone. While non-absorbable sutures may have greater tensile strength, the use of absorbable sutures has been found to reduce the risk for wound infection and improve healing. The objective of this multi-centre, nationwide randomized controlled study is to determine whether there is a difference in hernia recurrence when the repair is completed with absorbable polydioxanone suture versus permanent polypropylene suture. The study will also explore post-operative complications and quality of life. Recruitment will take place over 5 years with follow-up at the 30-day, 12-month and 24-month mark following surgery. The results of this trial will be directly applicable to national and international hernia guidelines and will impact the care of thousands of patients.
Elective surgery for primary umbilical hernia with a defect ≤ 2 cm measured clinically or radiographically
Age 19 years or older
Patient able to give oral and written informed consent
Umbilical hernia defect > 2 cm measured clinically, radiologically, or intraoperatively with ruler
Multiple defects
Incisional hernia: prior hernia in area of operation
Recurrent umbilical hernia
Parallel
Permanent Suture
Other interventionIn both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed in a standardized manner. In the control group, a permanent 0-0 polypropylene suture will be used to close the hernia defect in a transverse or vertical interrupted fashion using either the simple interrupted or the figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.
Absorbable
Other interventionIn both control and intervention groups, an open umbilical hernia repair will be performed based on a standardized surgical technique. Dissection and identification of the fascial defect will be performed. An 0-0 polydioxanone suture (PDS) will be used to close the hernia defect in either a transverse or vertical interrupted fashion using either simple interrupted or figure-of-eight technique. If the surgeon creates an opening in the umbilical skin or extends the skin incision beyond the paraumbilical incision during the procedure, the participant will be excluded from the study.
Recurrence
Recurrence will be diagnosed clinically at the time of follow-up. Clinical diagnosis of hernia recurrence will be determined by a standard medical assessment (ie. physical exam). In the event that clinical recurrence is uncertain, a computed tomography scan or ultrasound will be performed while the patient performs a Valsalva maneuver.
SSO
SSO will be diagnosed according to the Ventral Hernia Working Group definition which includes: surgical site infection, seroma, dehiscence, enterocutaneous fistula, surgical site infection, seroma, wound dehiscence, enterocutaneous fistula, wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma, and infected or exposed mesh.
SSOPI
Surgical Site Occurrences (SSOs) requiring a procedural intervention, defined as wound opening or debridement, suture excision, or percutaneous drainage
Quality of Life - HerQLes
The Hernia-Related Quality of Life Survey (HerQLes) is a validated patient-reported outcome measure specific to abdominal wall hernias, verified in a subgroup analysis of patients with small hernias. The HerQLes includes 12 statements related to the abdominal wall. Each of the 12 statements is scored from 1 to 6 (strongly disagree to strongly agree, respectively). Each statement covers a domain relevant to hernia-related QoL, and the scores can be compared for each statement and in aggregate. Summary scores are calculated using the following formula: (120-\[(20/12)∗(raw score)\]).
Quality of Life - SF-12
The 12-item Short Form Survey from the RAND Medical Outcomes Study (SF-12) is a general health status questionnaire, a truncated and validated version of the extensively used 36-item Short Form Survey (SF-36), used to assess baseline health and postoperative recovery. The SF-12 is a self-reported health-related QoL questionnaire comprised of 12 items, including 8 domains of health (physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health). In accordance with prior hernia research, the results of test items will be normalized and expressed in terms of 2 meta-scores: Physical Component Summary and Mental Component Summary. A higher SF-12 score is indicative of better functioning.
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University of British Columbia
Lead sponsor
North York General Hospital
Collaborator
Royal Victoria Hospital Of Barrie
Collaborator
London Health Sciences Centre
Collaborator
University of Alberta
Collaborator
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