Peritoneal antiseptic irrigation to prevent surgical site infection after laparotomy for hepatobiliary or gastrointestinal surgery (PAISI)—protocol for a randomized controlled study

Trials

Study Protocol

Daniel Reim¹  Alexander Novotny¹  Tara Mueller¹  Helmut Friess¹  Victoria Kehl²  Silvia Egert-Schwender² 

[1] Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich, München, Germany;Münchner Studienzentrum, School of Medicine, Technical University of Munich, München, Germany;

关键词: Surgical site infection;    Abdominal surgery;    Gastrointestinal surgery;    Hepatobiliary surgery;    Laparotomy;    Peritoneal irrigation;    Intracavity lavage;    Sodium hypochlorite;    Randomized controlled study;   

DOI  :  10.1186/s13063-022-06975-6

 received in 2022-06-27, accepted in 2022-12-02,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundPostoperative surgical site infections (SSIs) remain common after laparotomy for resections of the gastrointestinal or hepatobiliary tract. Especially organ/space infections (CDC class III SSI) can be life-threatening, require relaparotomy, intensive care or interventional drainage of intraabdominal abscesses. The PAISI study aims to investigate whether the use of prophylactic peritoneal irrigation with NaOCl/HOCl solution can reduce the SSI rates following laparotomy for resections of the gastrointestinal or hepatobiliary tract, compared to standard irrigation with physiological electrolyte solution (Ringer’s solution). Secondarily, to evaluate whether the use of prophylactic peritoneal irrigation with NaOCl/HOCl solution can reduce postoperative morbidity and mortality as well as the rate of re-operations and length of hospital stay.MethodsPAISI is a prospective, randomized, observer- and patient-blinded, monocentric, two-arm surgical study in an adaptive parallel groups design, comparing peritoneal and wound irrigation with NaOCl/HOCl (50/50ppm) solution to irrigation with Ringer’s solution. The primary endpoint of the study is the SSI rate within 30 days postoperatively. Since there is no data on incidence rates from randomized clinical trials, the rates for sample size calculation were estimated according to the clinical experience at our institution. Therefore, the study design includes one unblinded look at the data by a second statistician, which will be performed after half of the patients reached the primary endpoint. This interim information will be used to check the assumptions and if needed, the sample size will be adjusted. The O’Brien-Fleming spending function is used to determine the efficacy test boundary and the non-binding futility boundary. The one-sided z-test (Group sequential test of two proportions) at the 2.5% significance level with a total of two looks at the data will have overall 80% power.DiscussionThe results of this study will provide high-level evidence for future research and clinical recommendations regarding the use of NaOCl/HOCl solution in abdominal surgery and provide the participating patients the opportunity of a potentially improved treatment.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00028037. Registered on 27 May 2022.

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

Fig. 1