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

Cedars-Sinai Medical Center

Status: Completed

Conditions: Nausea/Vomiting

Treatments: Dietary Supplement: Low Residue diet arm.

Study type: Interventional

Funder types: Other

Identifiers

NCT01890499

Pro00029966

Details and patient eligibility

About

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.

Full 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:

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 laparoscopic); Elective Surgery.

Key Exclusion criteria are:

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. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations. Open upper abdominal surgical incisions. 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Low residue diet arm

Experimental group

Description:

Two arm randomized controlled trial. First arm is the Clear feeds on postoperative day one arm. The second arm (interventional arm) is the Low Residue diet on postoperative day one arm.

Treatment:

Dietary Supplement: Low Residue diet arm.

Clear feeds arm

Active Comparator group

Description:

Standard of care is to start clear feeds on postoperative day one for elective colorectal surgery patients.

Treatment:

Dietary Supplement: Low Residue diet arm.