Influence of nutrition on high-output ileostomy in patients with new ileostomy

Influence of nutrition on high-output ileostomy in patients with new ileostomy - NUTROMY

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030573

Enrollment

234

Registered

2022-10-25

Start date

2022-07-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-output ileostomy

Interventions

Group 1: All patients receive the diet which is specifically designed for patients with ileostomy postoperatively. Furthermore all patients is this trial will have nutritional advice from dietitians a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - new attachment of ileostomy (terminal or loop ileostomy) - elective surgery - open, laparoscopically-assisted or robotic-assisted surgery

Exclusion criteria

Exclusion criteria: - age < 18 years - preexisting ileostomy - attachment of colostomy - emergency surgery

Design outcomes

Primary

Measure	Time frame
Occurence of high-output-ileostomy two months postoperatively Definition: loss of > 1000 ml fluid stool per day on three consecutive days	—

Secondary

Measure	Time frame
- occurence of malnutrition preoperatively detected via Nutritional Risk Screening (NRS 2002 - occurence of malnutrition detected via Malnutrition Universal Screening Tool (MUST) two months postoperatively - need and amount of parenteral fluid substitution - need and amount of parenteral nutrition - time of first postoperative stool via ileostomy - frequency of leak of ileostomy bag - number of participants with medication for thickening of the stool - satisfaction assessed by the VAS from 0 (not satisfied) - 10 (completely satisfied) with the selection of food during hospital stay - number of participants with loss of weight - length of hospital stay in days - costs of hospital stay - number of participants with postoperative complications according to Clavien-Dindo - number of participants with need for reoperation - number of participants with readmission to ward - electrolyte deviation or deviations from laboratory parameters (sodium in mmol/l, potassium in mmol/l calcium in mmol/l, magnesium in mmol/l, creatinine in mg/dl, urea in mg/dl, albumine in mg/dl, protein in g/dl) - number of participants with acute renal failure	—

Measure

Time frame

- occurence of malnutrition preoperatively detected via Nutritional Risk Screening (NRS 2002 - occurence of malnutrition detected via Malnutrition Universal Screening Tool (MUST) two months postoperatively - need and amount of parenteral fluid substitution - need and amount of parenteral nutrition - time of first postoperative stool via ileostomy - frequency of leak of ileostomy bag - number of participants with medication for thickening of the stool - satisfaction assessed by the VAS from 0 (not satisfied) - 10 (completely satisfied) with the selection of food during hospital stay - number of participants with loss of weight - length of hospital stay in days - costs of hospital stay - number of participants with postoperative complications according to Clavien-Dindo - number of participants with need for reoperation - number of participants with readmission to ward - electrolyte deviation or deviations from laboratory parameters (sodium in mmol/l, potassium in mmol/l calcium in mmol/l, magnesium in mmol/l, creatinine in mg/dl, urea in mg/dl, albumine in mg/dl, protein in g/dl) - number of participants with acute renal failure

—

Countries

Germany

Contacts

Public ContactRahel Strobel

Allgemein- und ViszeralchirurgieCharité - Universitätsmedizin BerlinCampus Benjamin Franklin

rahel.strobel@charite.de030 450 622 727

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026