Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 7:04 PM
Study NCT ID:
NCT00328757
Status:
WITHDRAWN
Last Update Posted:
2011-06-28
First Post:
2006-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Regular Diet as the First Meal in Patients Who Underwent Surgical Treatment for Gynecologic Cancer
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
Regular Versus Liquid Diet as the First Meal in Patients Undergoing Major Abdominal Gynecologic Cancer Operation: A Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Before starting the recruitment process, new data from literature were available. The investigators considered that this study was no longer needed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Comparisons: Regular versus liquid diet as the first postoperative meal on the first day after surgery for clinically early-stage gynecologic cancer.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: