Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure
Condition: Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Surgical Wound
Study type: Interventional

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
    

Intervention name(s): application of a contralateral drainage (Penrose ® device)
Intervention type(s): Procedure
Intervention description(s): application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: superficial surgical site infection; loop ileostomy; Ileostomy closure