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Feeding Schedules After Surgery in Patients With Gynecologic Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742677
First Posted: August 28, 2008
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Abdominal pain and nausea and vomiting may be lessened by waiting after surgery before eating foods by mouth. It is not yet known which feeding schedule is more effective in patients undergoing surgery.

PURPOSE: This randomized clinical trial is comparing two feeding schedules after laparotomy in patients with gynecologic cancer.


Condition Intervention
Female Reproductive Cancer Procedure: nutritional support

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Length of hospital stay

Secondary Outcome Measures:
  • Incidence of symptoms of postoperative ileus (e.g., nausea, vomiting, time to feel intestinal activity, time to passage of flatus, and time to bowel movement)
  • Degree of postoperative abdominal pain
  • Global postoperative patient satisfaction
  • Quality of life using the EORTC OV-28 and EORTC QLQ-C30 questionnaires at baseline and at day 30
  • Postoperative requirement of antiemetic and analgesic medication
  • Postoperative complications

Estimated Enrollment: 180
Study Start Date: January 2007
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (early feeding)
Patients are offered a liquid diet on day 1 for 24 hours following surgery. Beginning on day 2, patients who tolerate a liquid diet are offered a light regular diet until hospital discharge.
Procedure: nutritional support
Given orally
Active Comparator: Group 2 (traditional feeding)
Patients are offered nothing by mouth on days 1 and 2 following surgery. Beginning on day 3, patients are offered a liquid diet for 24 hours. Beginning on day 4, patients who tolerate a liquid diet (absence of nausea and vomiting) are offered a semi-solid diet for 24 hours. Beginning on day 5, patients who tolerate a semi-solid diet are offered a light regular diet until hospital discharge.
Procedure: nutritional support
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To investigate the relationship between the different policies of realimentation (early oral feedings versus traditional feedings) and the length of hospital stay following a laparotomy in patients with gynecologic oncologic disease.
  • To assess the degree of postoperative abdominal pain in these patients.
  • To evaluate the incidence of ileus symptoms, including nausea and vomiting, and the postoperative recovery of intestinal activity in these patients.
  • To determine the incidence of postoperative complications in these patients.
  • To elucidate the global postoperative patient's satisfaction and the quality of life in both groups of patients.

OUTLINE: Patients are stratified according to laparotomy with or without intestinal resection (yes vs no), and presence of ovarian cancer (yes vs no). Patients are randomized to 1 of 2 groups at the end of surgery.

  • Group 1 (early feeding): Patients are offered a liquid diet on day 1 for 24 hours following surgery. Beginning on day 2, patients who tolerate a liquid diet are offered a regular diet until hospital discharge.
  • Group 2 (traditional feeding): Patients are offered nothing by mouth on days 1 and 2 following surgery. Beginning on day 3, patients are offered a liquid diet for 24 hours. Beginning on day 4, patients who tolerate a liquid diet (i.e., no nausea and vomiting) are offered a semi-solid diet for 24 hours. Beginning on day 5, patients who tolerate a semi-solid diet are offered a light regular diet until hospital discharge.

Data is collected through the Post-Operative Pain Questionnaire, Bowel Function Table, Global Postoperative Patient's Satisfaction Questionnaire, Postoperative Complication and Hospital Stay Questionnaire, and the Quality of Life Questionnaires EORTC OV-28 and EORTC QLQ-C30.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Preoperative diagnosis for probable gynecologic pathology

    • No benign pathology or final histopathology diagnosis confirmed as non-gynecologic disease
  • Admitted to the European Institute of Oncology
  • Elected to undergo laparotomic surgery

    • No total or anterior pelvic exenteration
    • No emergency laparotomy

PATIENT CHARACTERISTICS:

  • No metabolic pathology (e.g., diabetes mellitus type I)
  • No preoperative ASA score ≥ 4
  • No preoperative infection
  • No severe malnutrition (weight loss > 10% within the past 3 months)
  • No preoperative intestinal obstruction
  • No postoperative admission to the intensive care unit (ICU) for more than 24 hours
  • No severe concomitant medical condition

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior abdominal and/or pelvis radiotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742677


Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Lucas Minig, MD European Institute of Oncology
Principal Investigator: Roberto Biffi, MD European Institute of Oncology
Principal Investigator: Angelo Maggioni, MD European Institute of Oncology
  More Information

ClinicalTrials.gov Identifier: NCT00742677     History of Changes
Other Study ID Numbers: CDR0000612328
IEO-S328/506
First Submitted: August 27, 2008
First Posted: August 28, 2008
Last Update Posted: September 20, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
female reproductive cancer