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Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure

Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02574702
Enrollment
78
Registered
2015-10-14
Start date
2013-02-28
Completion date
2018-07-31
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

superficial surgical site infection, loop ileostomy, Ileostomy closure

Brief summary

1. 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

1. 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. 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. It will be used a simple randomization. To assess the occurrence of superficial incisional infection, the investigators will be monitoring patients till 30 days after surgery

Interventions

PROCEDUREapplication of a contralateral drainage (Penrose ® device)

application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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.

Design outcomes

Primary

MeasureTime frame
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application30 days

Secondary

MeasureTime frame
Number of patients with hematoma after ileostomy closure surgery30 days
Number of patients with seroma after ileostomy closure surgery30 days
Number of patients with anastomotic leak after ileostomy colsure surgery30 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026