Trial reportWorld journal of surgery2019
The Effectiveness of Contralateral Drainage in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial.
Trial report in World journal of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02574702 (Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
Who cites it
2 citing papers in PubMed.
- Micro-power negative pressure wound technique reduces risk of incision infection following loop ileostomy closure.World journal of gastrointestinal surgery · 2024Article
- Clinical Benefits of Reducing Dead Space Using a Closed Suction Drain and Subcutaneous Large-bite Buried Suture Technique to Prevent Superficial Surgical-site Infections Following Primary Closure of a Diverting Stoma.Journal of the anus, rectum and colon · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLoop ileostomy reduces the rates of morbidity due to colorectal anastomotic dehiscence. For its part, ileostomy closure is associated with low mortality (0-4%) but substantial morbidity (11-37%). Incisional surgical site infection (SSI) is one of the most frequent complications (2-40%).
methodsA single-center, prospective, randomized controlled clinical trial of two study groups: control (conventional primary skin closure) and experimental (primary skin closure with a contralateral Penrose
resultsSeventy patients undergoing loop ileostomy closure between April 2013 and June 2017 were included (35 per branch). Four were later removed from the study. Six of the remaining 66 patients (per protocol analysis) were diagnosed with incisional SSI (9.1%); there were no statistically significant differences between the two groups (control group: 9.7%; experimental group: 8.6%) or between the risk factors associated with incisional SSI. Rates of overall and relevant morbidity (Clavien ≥ III) were considerable (28.1% and 9.1%, respectively), and there were no statistically significant differences between the two groups. No patients died.
conclusionContralateral drainage does not significantly affect the results of primary ileostomy closure. The rate of incisional SSI was similar in the drainage and non-drainage groups, and the overall rate of 9.1% was in the low range of those reported in the literature. The absence of mortality (0%) and the non-negligible rates of overall and relevant morbidity (28.1% and 9.1%, respectively) in our series suggest that loop ileostomy is a safe procedure. However, the bowel reconstruction involves risks that must be borne in mind. CLINICAL
trial registrationThe study was registered and approved by the clinical research ethics committee of the study center (reference number 2012076). Clinical trial was registered in ClinicalTrial.gov (identification number NCT02574702 and reference: ILEOS-ISS_2013).
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Registered trials
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