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Feeding Schedules After Surgery in Patients With Gynecologic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00742677
First received: August 27, 2008
Last updated: September 26, 2009
Last verified: July 2009
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Length of hospital stay [ Designated as safety issue: No ]

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) [ Designated as safety issue: No ]
  • Degree of postoperative abdominal pain [ Designated as safety issue: No ]
  • Global postoperative patient satisfaction [ Designated as safety issue: No ]
  • Quality of life using the EORTC OV-28 and EORTC QLQ-C30 questionnaires at baseline and at day 30 [ Designated as safety issue: No ]
  • Postoperative requirement of antiemetic and analgesic medication [ Designated as safety issue: No ]
  • Postoperative complications [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00742677     History of Changes
Other Study ID Numbers: CDR0000612328, IEO-S328/506
Study First Received: August 27, 2008
Last Updated: September 26, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 19, 2013