N/A
Completed N=100
Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery
Nausea/Vomiting
Source: ClinicalTrials.gov NCT03260426 ↗
Enrolled (actual)
100
Serious AEs
22.0%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants Who Experienced Emesis on Post Operative Day 2 — 9; 9 Participants
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.
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 | — |
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. Informational only — not medical advice.