INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery.

BACKGROUND: Rehabilitation strategies after abdominal surgery enhance recovery and improve outcome. A cornerstone of rehabilitation is respiratory physiotherapy with inspiratory muscle training to enhance pulmonary function. Pre-habilitation is the process of enhancing functional capacity before surgery in order to compensate for the stress of surgery and postoperative recovery. There is growing interest in deploying pre-habilitation interventions prior to surgery. The aim of this study is to assess the impact of preoperative inspiratory muscle training on postoperative overall morbidity. The question is, whether inspiratory muscle training prior to elective abdominal surgery reduces the number of postoperative complications and their severity grade. METHODS: We describe a prospective randomized-controlled single-centre trial in a tertiary referral centre. The primary outcome is the Comprehensive Complication Index (CCI) at 90 days after surgery. The CCI expresses morbidity on a continuous numeric scale from 0 (no complication) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity. In the intervention group, patients will be instructed by physiotherapists to perform inspiratory muscle training containing of 30 breaths twice a day for at least 2 weeks before surgery using Power®Breathe KHP2. Depending on the surgical schedule, training can be extended up to 6 weeks. In the control group, no preoperative inspiratory muscle training will be performed. After the operation, both groups receive the same physiotherapeutic support. DISCUSSION: Existing data about preoperative inspiratory muscle training on postoperative complications are ambiguous and study protocols are often lacking a clear design and a clearly defined endpoint. Most studies consist of multi-stage concepts, comprehensively supervised and long-term interventions, whose implementation in clinical practice is hardly possible. There is a clear need for randomized-controlled studies with a simple protocol that can be easily transferred into clinical practice. This study examines the effortless adjustment of the common respiratory physiotherapy from currently postoperative to preoperative. The external measurement by the device eliminates the diary listing of patients' performances and allows the exercise adherence and thus the effect to be objectively recorded. TRIAL REGISTRATION: ClinicalTrials.gov NCT04558151 . Registered on September 15, 2020.

Experiences with the Kono-S anastomosis in Crohn's disease of the terminal ileum-a cohort study.

PURPOSE: The most frequent long-term complication after ileocecal resection in Crohn's disease is anastomotic recurrence and subsequent stenosis. Recurrence typically begins at the site of the anastomosis, raising the question of whether the surgical technique of the anastomosis could affect recurrence rates. Kono-S anastomosis is a hand-sewn antimesenteric functional end-to-end anastomosis that offers a wide lumen that is well accessible for endoscopic dilatation. The purpose of our study is to review the rate of postoperative complications almost 2 years after the introduction of this technique. MATERIALS AND METHODS: This is a prospective single-center cohort study of all consecutive patients with Crohn's disease undergoing ileocecal resection. Patients' characteristics as well as specific data for the surgical procedure and short-term outcome were evaluated. RESULTS: Thirty patients were operated for Crohn's disease of the terminal ileum (n = 24) or anastomotic recurrence (n = 6). Postoperative complications with a Clavien-Dindo Score ≥ IIIb were observed in three patients. One patient showed a hemorrhage and underwent surgical hemostasis. Two patients developed anastomotic leakage; in both cases, ileostomy was created after resection of the anastomosis. The median hospital stay was 9 days (IQR 7-12). A comparison with a historic group of conventionally operated patients of our hospital revealed no differences in short-term results except for the duration of surgery. CONCLUSION: The Kono-S anastomosis is associated with acceptable short-term results, complications, and recurrence rates comparable with the established anastomotic techniques. Longer operation times are observed, but the few published studies concerning long-term recurrence are promising.