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

This study has been withdrawn prior to enrollment.
(Before starting the recruitment process, new data from literature were available. The investigators considered that this study was no longer needed.)
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT00328757
First received: May 19, 2006
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Gynecologic Neoplasms
Behavioral: Regular diet as the first postoperative meal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Rate of clinically significant postoperative ileus

Secondary Outcome Measures:
  • Patient's satisfaction
  • Other postoperative complications
  • Time to first flatus
  • Amount of meal taken
  • Hospital stay

Estimated Enrollment: 240
Study Start Date: May 2006
Estimated Study Completion Date: April 2007
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328757

Locations
Thailand
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Muang Chiangmai, Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Kittipat Charoenkwan, M.D. Faculty of Medicine, Chiang Mai University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00328757     History of Changes
Other Study ID Numbers: OF-01
Study First Received: May 19, 2006
Last Updated: June 27, 2011
Health Authority: Thailand: Ethical Committee

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:
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014