The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05906017
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : June 26, 2023
Sponsor:
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:
In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 110 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.

Condition or disease Intervention/treatment Phase
Abdominal Hernia Procedure: Open Hernia surgery Procedure: Robotic Hernia surgery Not Applicable

Detailed Description:
Ventral hernias occur in up to 25% of the population. They are diverse in severity ranging from small umbilical hernias to large abdominal wall defects that may result in loss of domain. Approximately one-third are incisional hernias. Incisional hernias are usually more complex due to complications from previous surgery. The procedure may be complicated as a result of intraabdominal bowel adhesions and adhesions within the hernial sac. These factors cause discomfort and may complicate the repair. Ventral hernias may be repaired either through a minimally invasive laparoscopic procedure or an open approach. The laparoscopic repair was introduced in the 1990s and in 2003 the first robotic-assisted procedure was described in a porcine model. In 2012 the first series of robotic repairs were reported in humans. Due to the superior flexibility of the robotic instruments, there is a substantial interest in harnessing the advantages of the robotic platform. Because robotic repair differs in several technical aspects from the open approach, it is important to determine whether the short and long-term results differ between the two procedures. Furthermore, it remains unresolved whether the robotic procedure is able to provide comparable outcomes to the open repair when assessed for quality-of-life outcome measures. These questions are important to address in order to determine the most appropriate surgical options for individual patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
Actual Study Start Date : May 15, 2023
Estimated Primary Completion Date : May 15, 2025
Estimated Study Completion Date : May 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Open repair
Open ventral hernia repair
Procedure: Open Hernia surgery
primary midline ventral hernia repair - open

Experimental: Robotic-assisted repair
Robotic-assisted ventral hernia repair
Procedure: Robotic Hernia surgery
primary midline ventral hernia repair - robotic




Primary Outcome Measures :
  1. Change in satisfaction and quality of life [ Time Frame: From inclusion until 6 months after operation. ]
    Satisfaction and quality of life were measured preoperatively at the outpatient clinic using the "abdominal hernia questionnaire" (AHQ) translated into Danish. The AHQ has 4 possible answers (All of the time, Most of the time, Some of the time, None the time OR Strongly disagree, Somewhat disagree, Somewhat agree, Strongly agree OR Very unsatisfied, Somewhat dissatisfied, Somewhat satisfied, Very satisfied)


Secondary Outcome Measures :
  1. Operating time [ Time Frame: Time from first incision to wound closure ]
    Measured in minutes

  2. Length of hospital stay [ Time Frame: From inclusion and until six months after surgery. ]
    Length of hospital stay measured in days from admission to discharge.

  3. Change in Surgical stress response (CRP) [ Time Frame: measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3. ]
    The degree of systemic inflammatory response expressed by C- reactive protein in serum

  4. Hernia defect size [ Time Frame: Measured preoperatively ]
    Hernia defect size measured in mm either on CT scan or intraoperative.

  5. Intraoperative need of blood transfusion [ Time Frame: From first incision until last suture has been placed ]
    The amount of blood transfused during surgery measured in mL

  6. Change in surgical stress response (Interleukins) [ Time Frame: Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3. ]
    The degree of systemic inflammatory response expressed by cytokine levels in serum. All measurements will consist of weight/volume ratio (eg. CRP mg/L and IL-6 pg/mL)

  7. Treatment cost [ Time Frame: From inclusion until 6 months postoperatively ]
    Cost analysis of the two types of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≥18
  • ASA 1-3
  • Clinical and radiologic diagnosis of primary midline ventral hernia
  • Eligible to surgery according to a preoperative anaesthetic assessment
  • Informed consent
  • Able to understand written and oral Danish language

Exclusion Criteria:

  • Incarcerated ventral hernia requiring emergency surgery
  • Pregnancy
  • Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
  • Current cancer diagnosis
  • Previous laparotomy
  • History of psychiatric or addictive disorder that prevents the patient from participating in the trial
  • Co-existing inflammatory disease
  • Co-existing immunological disease that requires medication of any kind
  • BMI >35 kg/m2

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): NCT05906017


Contacts
Layout table for location contacts
Contact: Kristian Als Nielsen +45 79 97 00 00 Kristian.Als.Nielsen3@rsyd.dk
Contact: Michael Festersen Nielsen +45 79 97 00 00 Michael.Festersen.Nielsen@rsyd.dk

Locations
Layout table for location information
Denmark
Sygehus Sønderjylland Recruiting
Aabenraa, Southern Denmark, Denmark, 6200
Sponsors and Collaborators
University of Southern Denmark
Investigators
Layout table for investigator information
Study Director: Michael Festersen Nielsen Hospital of Southern Denmark - Aabenraa
Layout table for additonal information
Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT05906017    
Other Study ID Numbers: SHS-MT Kir-2-2023
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: June 26, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
Da Vinci
Robot
Umbilical hernia
Ventral hernia
Epigastric hernia
Hernia repair
Laparotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Hernia, Ventral
Hernia, Abdominal
Internal Hernia
Pathological Conditions, Anatomical