Female Reproductive CancerNCT00742677
Feeding Schedules After Surgery in Patients With Gynecologic Cancer
A study testing nutritional support in people with Female Reproductive Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Female Reproductive Cancer
- What is being tested?
- nutritional support
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Female Reproductive Cancer
- Being tested
- nutritional support
- Keywords
- female reproductive cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supportProcedure or surgery
Given orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: nutritional support |
| 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. Receives: Procedure: nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Reproductive CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Lucas Minig, MD, Principal investigator, European Institute of OncologyRoberto Biffi, MD, Principal investigator, European Institute of OncologyAngelo Maggioni, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742677
- Sponsor's protocol ID
- CDR0000612328
- Other IDs
- IEO-S328/506
- Status last verified
- Jul 2009
- First submitted
- 27 Aug 2008
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Feeding After a Gynaecologic Oncologic Laparotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00742677
- Acronym / sponsor ID
- CDR0000612328
- Conditions
- Female Reproductive Cancer
- Keywords
- female reproductive cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (estimated)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (early feeding) | Experimental | Procedure: nutritional supportPatients 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. |
| Group 2 (traditional feeding) | Active comparator | Procedure: nutritional supportPatients 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. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional supportGiven orally | Procedure or surgery | Group 1 (early feeding), Group 2 (traditional feeding) |
Primary outcome
Length of hospital stay
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Minig, MD principal investigator
European Institute of Oncology
Roberto Biffi, MD principal investigator
European Institute of Oncology
Angelo Maggioni, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional support in people with Female Reproductive Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.