NCT03260426

Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery

Completed NA Results posted Last updated 31 January 2020

What this trial tests

NA trial testing Clear Liquids in Nausea/Vomiting in 100 participants. Completed in 31 July 2018.

Timeline

16 August 2017

Primary endpoint
31 July 2018

31 July 2018

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	16 August 2017
Primary completion	31 July 2018
Estimated completion	31 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Clear Liquids
• Regular Solid
• Abstats

Conditions studied

• Nausea/Vomiting — all drugs for Nausea/Vomiting →

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Nausea/Vomiting. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Emesis on Post Operative Day 2 Primary · POD 2

Patient tolerability, as evidenced by development of vomiting on postoperative day two.

Group	Value	95% CI
Clear Liquid Diet	9
Regular Solid Diet	9

Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0). Secondary · POD 0

Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.

Group	Value	95% CI
Clear Liquid Diet	46
Regular Solid Diet	34

Antiemetic Usage Secondary · 30 days

If antiemetics were used in

Group	Value	95% CI
Clear Liquid Diet	37
Regular Solid Diet	30

Hospital Stay Secondary · 30 days

Length of postoperative stay

Group	Value	95% CI
Clear Liquid Diet	3	± 3.5
Regular Solid Diet	2.5	± 4.0

Post-operative Ileus Secondary · 30 days

Development of post-operative ileus

Group	Value	95% CI
Clear Liquid Diet	11
Regular Solid Diet	11

Pain Score Secondary · POD 1 and POD 2 and Discharge

Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.

POD 1

Group	Value	95% CI
Clear Liquid Diet	4	0 – 10
Regular Solid Diet	4	0 – 10

POD 2

Group	Value	95% CI
Clear Liquid Diet	3	0 – 10
Regular Solid Diet	4	0 – 10

Discharge

Group	Value	95% CI
Clear Liquid Diet	2	0 – 10
Regular Solid Diet	3	0 – 10

Nausea Score Secondary · POD 1 and POD 2 and Discharge

Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.

POD 1

Group	Value	95% CI
Clear Liquid Diet	1	0 – 10
Regular Solid Diet	1	0 – 10

POD 2

Group	Value	95% CI
Clear Liquid Diet	1	0 – 10
Regular Solid Diet	1	0 – 10

Discharge

Group	Value	95% CI
Clear Liquid Diet	1	0 – 10
Regular Solid Diet	1	0 – 10

Bloating Score Secondary · POD 1 and POD 2 and Discharge

Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome. Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.

POD 1

Group	Value	95% CI
Clear Liquid Diet	3	0 – 10
Regular Solid Diet	2	0 – 10

POD 2

Group	Value	95% CI
Clear Liquid Diet	2	0 – 10
Regular Solid Diet	2	0 – 10

POD 3

Group	Value	95% CI
Clear Liquid Diet	2	0 – 10
Regular Solid Diet	2	0 – 10

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Clear Liquid Diet

Serious: 11/50 (22%)

Deaths: 0/50

Regular Solid Diet

Serious: 11/50 (22%)

Deaths: 0/50

Serious adverse events (1 terms)

Reaction	System	Clear Liquid Diet	Regular Solid Diet
Post-operative Ileus	Gastrointestinal disorders	—	—

Most-reported serious reactions: Post-operative Ileus.

Data from ClinicalTrials.gov NCT03260426 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.