N/A
Completed N=280
SANICS II Trial: Stimulation of the Autonomic Nervous System in Colorectal Surgery by Perioperative Nutrition
Source: ClinicalTrials.gov NCT02175979 ↗Enrolled (actual)
280
Serious AEs
40.4%
Results posted
Sep 2019
Primary outcomePrimary: Number of Patients Developing Postoperative Ileus — 29; 37 Participants
Summary
The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery.
Perioperative enteral nutrition is compared to the standard of care (fasting perioperatively).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Developing Postoperative Ileus |
29; 37 | — |
| SECONDARY Anastomotic Leakage |
11; 12 | — |
| SECONDARY Aspiration Pneumonia |
0; 0 | — |
| SECONDARY Gastric Motility |
-32.7; -31.4 | — |
| SECONDARY Functional Recovery |
5; 5 | — |
| SECONDARY C-reactive Protein (CRP) |
150; 164 | — |
| SECONDARY Number of Patients Needing Additional Surgical, Radiological or Endoscopic Interventions |
21; 15 | — |
| SECONDARY Number of Patients Needing ICU Admission |
37; 31 | — |
| SECONDARY Health-related Quality of Life |
83; 78 | — |
Eligibility Criteria
Inclusion Criteria
- patients that undergo elective surgical resection of the colon or rectum with primary anastomosis.
- written informed consent
- age >18 years
Exclusion Criteria
- use of medication that disrupts acetylcholine metabolism
- steroid use
- previous gastric or esophageal resection
- peritoneal metastases found during surgery
- ileostomy
Data sourced from ClinicalTrials.gov (NCT02175979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.