Status:
COMPLETED
Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Nausea/Vomiting
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective randomized controlled trial investigating commencement of low residue diet versus clear liquids on postoperative zero following elective colorectal surgery, with regards to patient tolerab...
Detailed Description
Offering patients, a low residue diet on the first postoperative day (POD1) after colorectal surgery is safe and improves surgical outcomes and postoperative hospital stay. Early use of low solid is s...
Eligibility Criteria
Inclusion
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, \>18 years of age inclusive at the time of study screening;
- American Society of Anesthesiologists (ASA) Class I-III;
- Colorectal surgery (open and/or robotic/laparoscopic);
- Elective Surgery
Exclusion
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.
- Children \<18 years of age.
- Pre-operative clinical diagnosis of intestinal obstruction.
- Pre-existing known upper gastrointestinal disorders including hiatus hernia, gastroesophageal reflux disease, peptic ulcer disease.
- Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.
- Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).
- Pregnant patients.
- Bedbound or moribund patients.
- Pre-existing history of clinical depression.
- Epidural analgesia.
- Surgical procedures completed after 4pm
- Patients taking narcotics prior to elective colorectal surgery
- Exclusion Criteria After randomization:
- Postoperative diagnosis of intra-abdominal sepsis, including anastomotic leaks.
- Postoperative complications requiring early reoperation within the same hospital stay.
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03260426
Start Date
August 16 2017
End Date
July 31 2018
Last Update
January 31 2020
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048