Anna Serracant1, Xavier Serra-Aracil2, Laura Mora-López1, Anna Pallisera-Lloveras1, Sheila Serra-Pla1, Alba Zárate-Pinedo1, Salvador Navarro-Soto1. 1. Unidad de Coloproctología. Servicio de Cirugía General y Aparato Digestivo, Hospital Universitario Parc Taulí, Universidad Autónoma de Barcelona, Parc Tauli, 1, 08208, Sabadell, Barcelona, Spain. 2. Unidad de Coloproctología. Servicio de Cirugía General y Aparato Digestivo, Hospital Universitario Parc Taulí, Universidad Autónoma de Barcelona, Parc Tauli, 1, 08208, Sabadell, Barcelona, Spain. xserraa@gmail.com.
Abstract
BACKGROUND:Loop 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%). METHODS: A 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® drain). RESULTS:Seventy 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. CONCLUSION:Contralateral 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 REGISTRATION: The 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).
RCT Entities:
BACKGROUND: Loop 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%). METHODS: A 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® drain). RESULTS: Seventy 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 patientsdied. CONCLUSION: Contralateral 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 REGISTRATION: The 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).
Authors: L L Leape; T A Brennan; N Laird; A G Lawthers; A R Localio; B A Barnes; L Hebert; J P Newhouse; P C Weiler; H Hiatt Journal: N Engl J Med Date: 1991-02-07 Impact factor: 91.245
Authors: Pierre A Clavien; Jeffrey Barkun; Michelle L de Oliveira; Jean Nicolas Vauthey; Daniel Dindo; Richard D Schulick; Eduardo de Santibañes; Juan Pekolj; Ksenija Slankamenac; Claudio Bassi; Rolf Graf; René Vonlanthen; Robert Padbury; John L Cameron; Masatoshi Makuuchi Journal: Ann Surg Date: 2009-08 Impact factor: 12.969