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

Abdominal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906017
• Other study ID #: SHS-MT Kir-2-2023
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: June 2023
• Source: University of Southern Denmark
• Contact: Kristian Als Nielsen
• Phone: +45 79 97 00 00
• Email: Kristian.Als.Nielsen3[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Hernia
• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia

Intervention

Procedure:
• Open Hernia surgery
primary midline ventral hernia repair - open
• Robotic Hernia surgery
primary midline ventral hernia repair - robotic

Locations

Country	Name	City	State
Denmark	Sygehus Sønderjylland	Aabenraa	Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in satisfaction and quality of life	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)	From inclusion until 6 months after operation.
Secondary	Operating time	Measured in minutes	Time from first incision to wound closure
Secondary	Length of hospital stay	Length of hospital stay measured in days from admission to discharge.	From inclusion and until six months after surgery.
Secondary	Change in Surgical stress response (CRP)	The degree of systemic inflammatory response expressed by C- reactive protein in serum	measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3.
Secondary	Hernia defect size	Hernia defect size measured in mm either on CT scan or intraoperative.	Measured preoperatively
Secondary	Intraoperative need of blood transfusion	The amount of blood transfused during surgery measured in mL	From first incision until last suture has been placed
Secondary	Change in surgical stress response (Interleukins)	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)	Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3.
Secondary	Treatment cost	Cost analysis of the two types of treatment	From inclusion until 6 months postoperatively