None listed
Conditions
Brief summary
This is a Phase I and IIA prospective interventional study investigating a gas-based drain sensor for the early detection of anastomotic leak following colonic surgery. We hypothesise that this sensor will be able to detect complications earlier than standard care after surgery. 60 patients undergoing abdominal surgery at Auckland City Hospital will be recruited. Surgery will be conducted as usual, with the addition of the placement of an intraabdominal drain sensor at the time of surgery. Postoperative monitoring will continue for up to 1 week postoperatively to track intraperitoneal concentrations of intestinal gases, and this will be correlated with clinical outcomes. Safety and tolerability outcomes will also be evaluated.
Interventions
Placement of a gas-based anastomotic leak sensor drain at the time of surgery (taking approximately 5 minutes of operative time), with monitoring of intraperitoneal gas levels for up to 7 days postoperatively, after which point the drain will be removed. The drain tubing will be placed inside the abdomen, and connected to a small, portable, external gas sensor. Research staff will monitor participants postoperative progress during the study with twice daily clinical review. There is no differenc
Placement of a gas-based anastomotic leak sensor drain at the time of surgery (taking approximately 5 minutes of operative time), with monitoring of intraperitoneal gas levels for up to 7 days postoperatively, after which point the drain will be removed. The drain tubing will be placed inside the abdomen, and connected to a small, portable, external gas sensor. Research staff will monitor participants postoperative progress during the study with twice daily clinical review. There is no difference in the intervention between participants recruited in Stage 1 and Stage 2A.
Sponsors
The University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult patients aged 18 years and over • Undergoing intrabdominal surgery via either open or laparoscopic approach o No bowel resection or anastomosis (Stage 1 only) o Any colonic anastomosis, including ileocolic, colocolic, colorectal, or coloanal (Stage 2A only), with or without diverting ileostomy formation • Able to give informed consent • Able to understand the risks/benefit of the study
Exclusion criteria
• Inability to give informed consent • Patient refusal • Aged <18 years • Pregnancy • Active infection of abdominal wall • Known allergy to silicone • Expected hospital discharge on same day as surgery
Outcome results
None listed