Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
Study Overview
Brief Summary
- Introduction:
The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure. 2. Objectives and Hypothesis:
Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.
Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure. 3. Methodology:
Prospective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate. Monitorization until 30 days after surgery
Detailed Description
- Introduction:
The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). In the literature there are various techniques related to closing loop ileostomy that try to reduce the rate of infections recorded. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure. 2. Objectives and Hypothesis:
Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.
Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.
Secondary objectives:
- Identify risk factors associated with superficial surgical site infection in relation to a primary loop ileostomy closure (with or without drainage).
- Reducing hospital stay and care at home.
- Methodology:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.
- •Over 18 years.
- •Surgery scheduled.
- •Informed consent signed.
Exclusion Criteria
- •Patients with terminal ileostomy.
- •Patients with loop ileostomy different from any surgery of rectal cancer.
- •To require another surgical procedure added.
- •Urgent surgery.
- •Patient refusal to participate in the study.
Arms & Interventions
Control Group
Patients with primary loop ileostomy closure without drainage of the surgical wound
Drainage Group
Patients with the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.
Intervention: application of a contralateral drainage in surgical wound closure.
Intervention: application of a contralateral drainage (Penrose ® device) (Procedure)
Outcomes
Primary Outcomes
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
Time Frame: 30 days
Secondary Outcomes
- Number of patients with seroma after ileostomy closure surgery(30 days)
- Number of patients with anastomotic leak after ileostomy colsure surgery(30 days)
- Number of patients with hematoma after ileostomy closure surgery(30 days)
Investigators
Xavier Serra-Aracil
Medical Doctor
Corporacion Parc Tauli