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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.
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.
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
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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients with primary loop ileostomy closure without drainage of the surgical wound | |
| Drainage Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| application of a contralateral drainage (Penrose ® device) | Procedure | application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with hematoma after ileostomy closure surgery | 30 days | |
| Number of patients with seroma after ileostomy closure surgery | 30 days | |
| Number of patients with anastomotic leak after ileostomy colsure surgery |
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Inclusion Criteria:
Exclusion Criteria:
Patients with terminal ileostomy.
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Serra-Aracil, MD | Hospital Universitario Parc Tauli de Sabadell | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Parc Tauli de Sabadell | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30824960 | Derived | 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. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |