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Safety of Regular Diet as the First Meal in Patients Who Underwent Surgical Treatment for Gynecologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328757
Recruitment Status : Withdrawn (Before starting the recruitment process, new data from literature were available. The investigators considered that this study was no longer needed.)
First Posted : May 22, 2006
Last Update Posted : June 28, 2011
Information provided by:
Chiang Mai University

Brief Summary:
The purpose of this study is to determine whether it is safe to give a regular diet as the first postoperative meal in patients who underwent surgical treatment for clinically early-stage gynecologic cancer.

Condition or disease Intervention/treatment Phase
Gynecologic Neoplasms Behavioral: Regular diet as the first postoperative meal Phase 3

Detailed Description:

Paralytic ileus, a temporary inhibition of bowel motility, is believed to follow all abdominal surgery. Surgeons have customarily withheld postoperative oral intake until the return of bowel function as evidenced by a presence of bowel sound, a passing of flatus/stool, and a feeling of being hungry. The major concern has been that early oral intake would result in vomiting from severe paralytic ileus with subsequent aspiration pneumonia, wound dehiscence, and anastomotic leakage. Recently, the practice of delayed postoperative oral intake has been challenged by evidence from extensive gastrointestinal physiologic studies that examine contractile activity of the intestine. These data have suggested that the concept of postoperative ileus as paralysis of the entire bowel with complete absence of any functional contractile activity is misleading. If postoperative ileus takes place, it is usually transient and not significant clinically. Several possible clinical benefits of early feeding after surgery exist that include better wound healing, postoperative stress ulcer prevention, reduced sepsis, improved sense of well being, shorter length of hospital stay, and cost saving. Currently, the practice of early administration of liquid diet after surgery has become widely accepted. For early regular diet administration, the proposed additional benefits would be lesser risk of aspiration, faster recovery of intestinal motility, and better nutritional status. Patients who had surgery as a treatment for gynecologic cancer deserve special attention in this regard as they generally have higher risk of developing postoperative ileus due to extensive and/or multiple intraabdominal surgical procedures including radical hysterectomy, pelvic lymph node dissection, and surgical staging procedures. At the same time, this is the group of patients that would benefit most from the aforementioned positive effects of early regular diet feeding.

Comparisons: Regular versus liquid diet as the first postoperative meal on the first day after surgery for clinically early-stage gynecologic cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Regular Versus Liquid Diet as the First Meal in Patients Undergoing Major Abdominal Gynecologic Cancer Operation: A Randomized Controlled Trial
Study Start Date : May 2006
Estimated Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rate of clinically significant postoperative ileus

Secondary Outcome Measures :
  1. Patient's satisfaction
  2. Other postoperative complications
  3. Time to first flatus
  4. Amount of meal taken
  5. Hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically early-stage gynecologic cancer patients who underwent standard abdominal surgery as a primary treatment of their diseases

Exclusion Criteria:

  • Peritonitis
  • Perioperative hyperalimentation
  • Bowel surgery (except appendectomy)
  • Bowel obstruction
  • History of bowel surgery or inflammatory bowel syndromes
  • History of abdominal/pelvic radiotherapy
  • Need for continued postoperative endotracheal tube or naso/orogastric tube placement
  • Need for postoperative Intensive Care Unit (ICU) administration
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328757

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Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Muang Chiangmai, Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
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Principal Investigator: Kittipat Charoenkwan, M.D. Faculty of Medicine, Chiang Mai University
Layout table for additonal information Identifier: NCT00328757    
Other Study ID Numbers: OF-01
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011
Keywords provided by Chiang Mai University:
gynecologic cancer
cervical cancer
ovarian cancer
endometrial cancer
radical abdominal hysterectomy
pelvic lymphadenectomy
surgical staging
postoperative feeding
Early-stage gynecologic cancer patients
Additional relevant MeSH terms:
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Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site