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

Primary Purpose

Gynecologic Neoplasms

Status
Withdrawn
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Regular diet as the first postoperative meal
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Neoplasms focused on measuring gynecologic cancer, cervical cancer, ovarian cancer, endometrial cancer, radical abdominal hysterectomy, pelvic lymphadenectomy, surgical staging, postoperative feeding, Early-stage gynecologic cancer patients

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Outcomes

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

Full Information

First Posted
May 19, 2006
Last Updated
June 27, 2011
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT00328757
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Before starting the recruitment process, new data from literature were available. The investigators considered that this study was no longer needed.
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chiang Mai University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Regular diet as the first postoperative meal
Primary Outcome Measure Information:
Title
Rate of clinically significant postoperative ileus
Secondary Outcome Measure Information:
Title
Patient's satisfaction
Title
Other postoperative complications
Title
Time to first flatus
Title
Amount of meal taken
Title
Hospital stay

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kittipat Charoenkwan, M.D.
Organizational Affiliation
Faculty of Medicine, Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
City
Muang Chiangmai
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
8607572
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.
Results Reference
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PubMed Identifier
11430967
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.
Results Reference
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PubMed Identifier
11004367
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.
Results Reference
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Safety of Regular Diet as the First Meal in Patients Who Underwent Surgical Treatment for Gynecologic Cancer

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