N/A
N=100
Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery
Nausea/Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT03260426 ↗Enrolled (actual)
100
Serious AEs
22.0%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants Who Experienced Emesis on Post Operative Day 2 — 9; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clear Liquids (Dietary_supplement); Regular Solid (Dietary_supplement); Abstats (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Emesis on Post Operative Day 2 |
9; 9 | — |
| SECONDARY Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0). |
46; 34 | — |
| SECONDARY Antiemetic Usage |
37; 30 | — |
| SECONDARY Hospital Stay |
3; 2.5 | — |
| SECONDARY Post-operative Ileus |
11; 11 | — |
| SECONDARY Pain Score |
4; 4; 3; 4; 2; 3 | — |
| SECONDARY Nausea Score |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Bloating Score |
3; 2; 2; 2; 2; 2 | — |
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 tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03260426). 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.