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Regular Versus Liquid Diet as the First Meal in Patients Undergoing Major Abdominal Gynecologic Cancer Operation: A Randomized Controlled Trial

Phase 3
18 Years
75 Years
Not Enrolling
Gynecologic Neoplasms

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Trial Information

Regular Versus Liquid Diet as the First Meal in Patients Undergoing Major Abdominal Gynecologic Cancer Operation: A Randomized Controlled Trial

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Rate of clinically significant postoperative ileus

Principal Investigator

Kittipat Charoenkwan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty of Medicine, Chiang Mai University


Thailand: Ethical Committee

Study ID:




Start Date:

May 2006

Completion Date:

April 2007

Related Keywords:

  • Gynecologic Neoplasms
  • gynecologic cancer
  • cervical cancer
  • ovarian cancer
  • endometrial cancer
  • radical abdominal hysterectomy
  • pelvic lymphadenectomy
  • surgical staging
  • postoperative feeding
  • Early-stage gynecologic cancer patients
  • Neoplasms
  • Genital Neoplasms, Female