Feeding Schedules After Surgery in Patients With Gynecologic Cancer - Full Text View

Sponsored by:	European Institute of Oncology
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00742677

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

MedlinePlus related topics: Abdominal Pain Cancer Nausea and Vomiting Nutritional Support

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial

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 questionnaire 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
Group 1 (early feeding): Experimental 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
Group 2 (traditional feeding): Active Comparator 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

Arms

Assigned Interventions

Group 1 (early feeding): Experimental

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

Group 2 (traditional feeding): Active Comparator

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 verus 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	Recruiting
Milan, Italy, 20141
Contact: Lucas Minig, MD 39-02-5748-9861

Sponsors and Collaborators

European Institute of Oncology

Investigators

Principal Investigator:	Lucas Minig, MD	European Institute of Oncology
Principal Investigator:	Robert Biffi, MD	European Institute of Oncology
Principal Investigator:	Angelo Maggioni, MD	European Institute of Oncology

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000612328, IEO-S328/506
Study First Received:	August 27, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00742677
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

female reproductive cancer

ClinicalTrials.gov processed this record on January 16, 2009