Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03787537
Other study ID # EA2/094/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date December 31, 2018

Study information

Verified date January 2019
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- patients undergoing elective surgery of the upper or lower gastrointestinal tract

- mental and verbal ability to understand, read and write in German language

- written informed consent for study participation

Exclusion Criteria:

- age <18 years

- inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires

Study Design


Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in nutritional status Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7 24 hours pre-surgery and 7 days after surgery
Secondary Energy intake Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day 1 day before surgery, the day of surgery and up to 7 days after surgery
Secondary Change in plasma amino acid levels Blood sample analysis 24 hours pre-surgery up to 7 days after surgery
Secondary Change in beta-hydroxybutyrate levels Blood sample analysis 24 hours pre-surgery up to 7 days after surgery
Secondary Change in free fatty acid levels Blood sample analysis 24 hours pre-surgery up to 7 days after surgery
Secondary Change in triacylglycerides levels Blood sample analysis 24 hours pre-surgery up to 7 days after surgery
Secondary Change in low density lipoprotein levels Blood sample analysis 24 hours pre-surgery up to 7 days after surgery
Secondary length of hospital stay 14 days
See also
  Status Clinical Trial Phase
Suspended NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Not yet recruiting NCT05775146 - SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases Phase 2
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A