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Completed

NCT Number: NCT01890499

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.
  • 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.

Treatment and study plan

Low Residue diet arm.

Dietary Supplement

Interventional arm is to provide low residue diet on postoperative day one.

Primary outcomes

  1. Development of nausea and vomiting on postoperative day two

    Time frame: postoperative day two

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2013
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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