Clinical trial NCT02574702: Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure
Official title: Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: superficial surgical site infection
loop ileostomy
Ileostomy closure
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with hematoma after ileostomy closure surgery
timeFrame: 30 days
measure: Number of patients with seroma after ileostomy closure surgery
timeFrame: 30 days
measure: Number of patients with anastomotic leak after ileostomy colsure surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Tauli de Sabadell
state: Barcelona
Study officials:
affiliation: Hospital Universitario Parc Tauli de Sabadell
name: Xavier Serra-Aracil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serracant A, Serra-Aracil X, Mora-Lopez L, Pallisera-Lloveras A, Serra-Pla S, Zarate-Pinedo A, Navarro-Soto S. The Effectiveness of Contralateral Drainage in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1692-1699. doi: 10.1007/s00268-019-04972-6.