Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients

Nausea/Vomiting Clinical Trial

Official title:

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ON CLEAR FEEDS VERSUS LOW RESIDUE DIET AFTER SURGERY IN ELECTIVE COLORECTAL SURGERY PATIENTS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890499
• Other study ID #: Pro00029966
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: February 2, 2015
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Prospective randomized controlled trial investigating commencement of low residue diet versus clear feeds on postoperative day one following elective colorectal surgery, with regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.

Description:

Based on current literature, the incidence of postoperative nausea and vomiting varies widely and can reach up to 40% in abdominal surgery patients. Thus, patient tolerability to postoperative enteral feeds is taken as 60%. This is a superiority trial: group one is the clear feeds group and patient tolerability in this group is taken to be 60%. Group two is the low residue diet group.

The primary hypothesis is that the incidence of postoperative ileus is not affected by the consistency of enteral diet given, and patients who are placed on low residue diet from postoperative day one do not have an increased risk of postoperative nausea and vomiting as compared to patients who are placed on clear feeds.

The primary endpoint measured is Patient tolerability, as evidenced by development of vomiting on postoperative day two.

Key Inclusion criteria are:

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

2. Males or females, >18 years of age inclusive at the time of study screening;

3. American Society of Anesthesiologists (ASA) Class I-III;

4. Colorectal surgery (open and/or laparoscopic);

5. Elective Surgery.

Key Exclusion criteria are:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.

2. Children <18 years of age.

3. Pre-operative clinical diagnosis of intestinal obstruction.

4. Pre-existing known upper gastrointestinal disorders.

5. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.

6. Open upper abdominal surgical incisions.

7. Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).

8. Pregnant patients.

9. Bedbound or moribund patients.

10. Pre-existing history of clinical depression.

11. Epidural analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

2. Males or females, >18 years of age inclusive at the time of study screening;

3. American Society of Anesthesiologists (ASA) Class I-III;

4. Colorectal surgery (open and/or laparoscopic);

5. Elective Surgery.

Exclusion Criteria:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.

2. Children <18 years of age.

3. Pre-operative clinical diagnosis of intestinal obstruction.

4. Pre-existing known upper gastrointestinal disorders.

5. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.

6. Open upper abdominal surgical incisions.

7. Colorectal surgery with concomitant resectional surgery of the stomach or proximal jejunum (small bowel).

8. Pregnant patients.

9. Bedbound or moribund patients.

10. Pre-existing history of clinical depression.

11. Epidural analgesia.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea/Vomiting

Intervention

Dietary Supplement:
• Low Residue diet arm.
Interventional arm is to provide low residue diet on postoperative day one.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of nausea and vomiting on postoperative day two		postoperative day two	Yes