ILEOSTIM trial: a study protocol to evaluate the effectiveness of efferent loop stimulation before ileostomy reversal

Techniques in Coloproctology https://doi.org/10.1007/s10151-023-02807-0 ORIGINAL ARTICLE ILEOSTIM trial: a study protocol to evaluate the effectiveness of efferent loop stimulation before ileostomy reversal N. Blanco1 · I. Oliva2 · P. Tejedor3 · E. Pastor2 · A. Alvarellos4 · C. Pastor4 · J. Baixauli1 · J. Arredondo1 Received: 3 April 2023 / Accepted: 12 April 2023 © The Author(s) 2023 Abstract Purpose A protective loop ileostomy is the most useful method to reduce sequelae in the event of an anastomotic leakage (AL) after rectal cancer surgery. However, it requires an additional stoma reversal surgery with its own potential complications. Postoperative ileus (POI) remains the most common complication after ileostomy reversal, which leads to an increase in morbidity, length of hospital stay (LOS) and overall healthcare costs. Several retrospective studies carried out in this field have concluded that there are insufficient evidence-based recommendations about the routine application of preoperative bowel stimulation in clinical practice. Here we discuss whether stimulation of the efferent limb before ileostomy reversal might reduce POI and improve postoperative outcomes. Methods This is a multicentre randomised controlled trial to determine whether mechanical stimulation of the efferent limb during the 2 weeks before the ileostomy reversal would help to reduce the development of POI after surgery. This study was registered on Clinicaltrials.gov (NCT05302557). Stimulation will consist of infusing a solution of 500 ml of saline chloride solution mixed with a thickening agent (Resource©, Nestlé Health Science; 6.4 g sachet) into the distal limb of the ileostomy loop. This will be performed within the 2 weeks before ileostomy reversal, in an outpatient clinic under the supervision of a trained stoma nurse. Conclusion The results of this study could provide some insights into the preoperative management of these patients. Keywords Postoperative ileus · Loop ileostomy · Ileostomy reversal · Bowel stimulation · Low anterior resection Introduction The use of a derivative loop ileostomy is an effective method recommended to mitigate potential severe intra-abdominal sepsis caused by an anastomotic leakage (AL), one of the most dreaded complications after colorectal surgery [1–5]. The collaborators for the ILEOSTIM Trial Group are listed in the Acknowledgements. * J. Arredondo 1 Department of General Surgery, Clínica Universidad de Navarra, Av. Pío XII 36, 31008 Pamplona, Navarra, Spain 2 Department of General Surgery, University Hospital of León, León, Spain 3 Department of General Surgery, University Hospital Gregorio Marañón, Madrid, Spain 4 Department of General Surgery, Clínica Universidad de Navarra, Madrid, Spain This procedure is commonly performed after a low anterior resection (LAR) with total mesorectal excision [6]. Reversal of the ileostomy means a second planned surgery, in which the rate of postoperative complications varies from 11% to 45% [7, 8]; of these complications, postoperative ileus (POI) is the most commonly observed with an incidence as high as 32% [9–15]. After the formation of an ileostomy, many structural and functional changes occur in the defunctionalized bowel, and these changes may contribute to the development of POI [16]. Thus, some studies have suggested that preoperative stimulation of the excluded bowel segment may positively impact the outcomes after ileostomy reversal [17], by changing the microbial dysbiosis and atrophy. These changes will improve the absorptive and motor function of the bowel before restoring intestinal continuity, thereby reducing the incidence of POI [17, 18]. Although different modalities of stimulation of the stoma have been described, there is a lack of evidence regarding which one is best, how to best perform it, and how long this 13 Vol.:(0123456789) Techniques in Coloproctology stimulation should be performed [19, 20]. Thus, the main purpose of this study is to assess whether the stimulation during a 2-week period before the reversal would reduce the incidence of POI. We will analyse and compare shortand mid-term results, complications, length of hospital stay (LOS) and functional outcomes of patients with and without preoperative stimulation. Patients and methods Eligibility criteria and sample size We have designed a multicentre, non-blinded randomised controlled trial. The inclusion criteria will be (1) adult patients (over 18 years old) undergoing elective surgery for a loop ileostomy reversal due to a previous LAR for rectal cancer; (2) all patients should be included in a standardised protocol using a water-soluble enema to prove the absence of anastomotic complications (such as leakage or stenosis Fig. 1  Flow diagram showing each stage of the trial, with randomisation at a ratio of 1:1 13 before the stoma reversal). The exclusion criteria will be patients undergoing any other surgical procedure at the time of the reversal, patients with a stoma for reasons other than rectal cancer or patients with previous surgeries performed involving the distal ileum. The designated surgeons at each participating centre will recruit potential patients to the study. At the time of planning the ileostomy reversal, all patients will be informed about the aim of the study, its possible benefits, secondary risks and the stimulation treatment protocol. Signed informed consent will be obtained from every individual patient included in the study. Participation in the study will not affect any other treatment considerations. After inclusion in the study, patients will be randomised to an intervention or control group, as shown in Fig. 1. In the interventional arm, patients will undergo daily stimulation of the efferent limb of the ileostomy, starting 2 weeks prior to the date of surgery. In the control group, patients will not undergo any preoperative treatments before the stoma reversal. Techniques in Coloproctology Randomisation Randomisation will be performed in a 1:1 ratio in each hospital using the Sealed Envelope© randomisation service program. Patients will be randomised either to the interventional or control group after obtaining their consent. The attending surgeon will then be informed of the patient’s treatment group. The researcher will not know the assigned group when obtaining the patient’s consent because the randomisation will be performed afterwards. A flow diagram outlining the proposed study is shown in Fig. 1. Preoperative efferent bowel stimulation All patients enrolled in the study will follow the same preoperative protocol. In the interventional arm, the stimulation will consist of irrigation with a mix of 500 ml of saline chloride solution and a nutritional thickener ( Resource©, Nestlé Health Science, 6.4 g sachet). The patient will be instructed on how to perform the stimulation, and supervised by a specialist stoma nurse in an outpatient clinic setting, beginning 2 weeks before (...truncated)