Surgical Wound InfectionNCT02574702
Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure
A study testing application of a contralateral drainage (Penrose ® device) in people with Surgical Wound Infection, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- application of a contralateral drainage (Penrose ® device)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.
- Over 18 years.
- Surgery scheduled.
- Informed consent signed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Parc Tauli de Sabadell
Sabadell, Barcelona, 08208
About this study
Official title: Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
- 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
Read the 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.
- 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:
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
- Conditions
- Surgical Wound Infection
- Being tested
- application of a contralateral drainage (Penrose ® device)
- Keywords
- superficial surgical site infection, loop ileostomy, Ileostomy closure
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of a contralateral drainage (Penrose ® device)Procedure or surgery
application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: application of a contralateral drainage (Penrose ® device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
Measured: 30 days
Secondary outcomes (3)
Number of patients with hematoma after ileostomy closure surgery
Measured: 30 days
Number of patients with seroma after ileostomy closure surgery
Measured: 30 days
Number of patients with anastomotic leak after ileostomy colsure surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
- Investigators
- Xavier Serra-Aracil, MD, Principal investigator, Hospital Universitario Parc Tauli de Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574702
- Sponsor's protocol ID
- ILEOS-ISS_2013
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2013
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30824960
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
- ClinicalTrials.gov ID
- NCT02574702
- Acronym / sponsor ID
- ILEOS-ISS_2013
- Conditions
- Surgical Wound Infection
- Keywords
- superficial surgical site infection, loop ileostomy, Ileostomy closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
- 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:
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients with primary loop ileostomy closure without drainage of the surgical wound |
| Drainage Group | Experimental | Procedure: application of a contralateral drainage (Penrose ® device)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.
- Over 18 years.
- Surgery scheduled.
- Informed consent signed.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of a contralateral drainage (Penrose ® device)application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure | Procedure or surgery | Drainage Group |
Primary outcome
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
Time frame: 30 days
3 secondary outcomes
Number of patients with hematoma after ileostomy closure surgery
Time frame: 30 days
Number of patients with seroma after ileostomy closure surgery
Time frame: 30 days
Number of patients with anastomotic leak after ileostomy colsure surgery
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 30824960Serracant 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Serra-Aracil, MD principal investigator
Hospital Universitario Parc Tauli de Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of a contralateral drainage (Penrose ® device) in people with Surgical Wound Infection, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.