Clinical trial NCT00328757: Safety of Regular Diet as the First Meal in Patients Who Underwent Surgical Treatment for Gynecologic Cancer
Official title: Regular Versus Liquid Diet as the First Meal in Patients Undergoing Major Abdominal Gynecologic Cancer Operation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gynecologic Neoplasms
Keywords: gynecologic cancer
cervical cancer
ovarian cancer
endometrial cancer
radical abdominal hysterectomy
pelvic lymphadenectomy
surgical staging
postoperative feeding
Early-stage gynecologic cancer patients
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2006-05-22
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of clinically significant postoperative ileus
Secondary outcomes:
measure: Patient's satisfaction
measure: Other postoperative complications
measure: Time to first flatus
measure: Amount of meal taken
measure: Hospital stay
Other outcomes:
Locations:
city: Muang Chiangmai
country: Thailand
facility: Department of OB-GYN, Faculty of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Kittipat Charoenkwan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeffery KM, Harkins B, Cresci GA, Martindale RG. The clear liquid diet is no longer a necessity in the routine postoperative management of surgical patients. Am Surg. 1996 Mar;62(3):167-70.
citation: Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. doi: 10.1016/s0029-7844(01)01387-4.
citation: MacMillan SL, Kammerer-Doak D, Rogers RG, Parker KM. Early feeding and the incidence of gastrointestinal symptoms after major gynecologic surgery. Obstet Gynecol. 2000 Oct;96(4):604-8. doi: 10.1016/s0029-7844(00)00957-1.