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

Gynecologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00328757
• Other study ID #: OF-01
• Status: Withdrawn
• Phase: Phase 3
• First received: May 19, 2006
• Last updated: June 27, 2011
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: June 2011
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 240
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Gynecologic Neoplasms

Intervention

Behavioral:
• Regular diet as the first postoperative meal

Locations

Country	Name	City	State
Thailand	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Muang Chiangmai	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View Citation

Patolia DS, Hilliard RL, Toy EC, Baker B. Early feeding after cesarean: randomized trial. Obstet Gynecol. 2001 Jul;98(1):113-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinically significant postoperative ileus
Secondary	Patient's satisfaction
Secondary	Other postoperative complications
Secondary	Time to first flatus
Secondary	Amount of meal taken
Secondary	Hospital stay