Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
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ClinicalTrials.gov Identifier: NCT05906017 |
Recruitment Status :
Recruiting
First Posted : June 15, 2023
Last Update Posted : June 26, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Abdominal Hernia | Procedure: Open Hernia surgery Procedure: Robotic Hernia surgery | Not Applicable |
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 |
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 |
- 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)
- Operating time [ Time Frame: Time from first incision to wound closure ]Measured in minutes
- 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.
- 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
- Hernia defect size [ Time Frame: Measured preoperatively ]Hernia defect size measured in mm either on CT scan or intraoperative.
- 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
- 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)
- Treatment cost [ Time Frame: From inclusion until 6 months postoperatively ]Cost analysis of the two types of treatment
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
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 |
Denmark | |
Sygehus Sønderjylland | Recruiting |
Aabenraa, Southern Denmark, Denmark, 6200 |
Study Director: | Michael Festersen Nielsen | Hospital of Southern Denmark - Aabenraa |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Da Vinci Robot Umbilical hernia Ventral hernia |
Epigastric hernia Hernia repair Laparotomy |
Hernia Hernia, Ventral Hernia, Abdominal Internal Hernia Pathological Conditions, Anatomical |