Clinical Research Directory

Preoperative Fish Oil PN and Prognosis After Constipation Surgery

This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery. The study will compare two clinical nutrition strategies: (1) PN with fish oil-containing lipid emulsion started before surgery and continued after surgery, and (2) PN with fish oil-containing lipid emulsion started only after surgery. Eligible participants are adults (18-75 years) with slow-transit constipation (STC) or megacolon who are scheduled for elective colon surgery and have nutritional risk (NRS2002 score \>=3). The primary objective is to compare the incidence of postoperative complications between these two PN timing strategies. Secondary objectives include comparison of perioperative nutritional status, postoperative inflammatory status, prognosis, and safety outcomes. This study will collect and analyze clinical data, laboratory indicators, perioperative recovery outcomes, follow-up assessments, and safety information in routine clinical practice. Outcomes include postoperative complication rates, changes in nutritional and inflammatory markers, bowel function recovery, length of hospital stay, constipation-related symptoms, quality of life, and adverse events. No experimental intervention will be assigned as part of this observational study. The planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.

Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation

Lubiprostone has established efficacy and a favorable safety profile in chronic constipation and irritable bowel syndrome with constipation (IBS-C). However, clinical data specifically supporting its use in slow-transit constipation (STC), a distinct subtype of chronic constipation, remains limited.

MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

The project presented here is a monocentric clinical study conducted by the Pediatric Surgery and Pediatrics departments of the University Hospital Erlangen. The study aims to experimentally expand the diagnostic approach for patients aged 0-17 years suffering from chronic bowel emptying disorders, regardless of any underlying causal or previously treated conditions. At the core of this clinical study is the application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time in children. Unlike conventional X-ray diagnostics, MSOT is radiation-free and considered non-invasive, although it has not yet been standardized for routine clinical use. Additionally, a contrast-free, non-invasive MRI technique will be employed to assess the peristalsis of intestinal segments. The study aims to standardize the collection and evaluation of patient data following the administration of ICG and subsequent measurements using MSOT and MRI. The objective is to assess gastrointestinal transit time and peristalsis and, ultimately, to optimize therapy for affected patients. This is of particular importance in the coloproctology specialist consultation within the Pediatric Surgery and Pediatrics departments, as follows: It enables differentiation between patients with slow transit constipation and outlet obstruction. It allows for a more targeted application and evaluation of neuromodulation therapy, which is used within clinical studies. This approach allows for the identification of specific intestinal segments with delayed transit time, enabling targeted electrical stimulation of these regions. A control group of healthy adult volunteers will participate in the study on a voluntary basis.

STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.