Digestive System CancerNCT03763526
Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients
An observational study of Digestive System Cancer, run by Mahidol University at 1 site in Thailand.
Trial summary
Malnutrition is a common problem in cancer patients. It negatively influences patients' prognosis and quality of life. In gastrointestinal patients, it is also caused by insufficient food intake due to dysphagia, lack of appetite, nausea, vomiting, impaired digestion and absorption. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digestive System Cancer
- How many people
- 196 participants
- Where
- 1 siteThailand
- Study dates
- 20 Dec 2018to 1 Aug 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery.
Who may be able to join
- All patients GI cancer
- Elective surgery
Who cannot join
- Lack of oncologic treatment information before surgery
- No history of recurrent cancer or more than one cancer disease
- Patients who have been diagnosed with Carcinomatosis peritonei during the operation
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition is a common problem in cancer patients. It negatively influences patients' prognosis and quality of life. In gastrointestinal patients, it is also caused by insufficient food intake due to dysphagia, lack of appetite, nausea, vomiting, impaired digestion and absorption.
Furthermore, influence of prior oncologic treatment (surgery, chemotherapy, and radiotherapy), have been associated with prolonged hospital stay, more postoperative complications and low survival outcome1-4. So, the proper assessment of nutrition status to detect perioperative malnutrition may allow appropriate nutritional therapy and improve survival5.
Read more
However, the important factor which prolongs survival rate is good preoperative nutrition status because it effects the postoperative nutrition outcome. The objective of this study is to correlate the association between pre- and postoperative nutrition status and surgical outcomes.
The Nutrition Alert Form (NAF) is a clinical tool for determining nutritional status. The NAF was modified from Subjective Global Assessment (SGA)6, and it is easy to use and does not require nutritional expertise based on laboratory and physical examination. Therefore, the NAF has been used extensively for screening of malnutrition in hospitalized Thai patients and it can classify the nutritional status into three groups : NAF-A (Normal-Mild malnutrition), NAF-B (Moderate malnutrition), NAF-C (Severe malnutrition)
Read the detailed description
Primary Questions
- What is the relationship between the preoperative nutrition status and the postoperative nutrition status in gastrointestinal cancer patients ?
Secondary Questions
- What is the relationship between malnutrition during preoperative and postoperative stages, compared with postoperative complications?
OBJECTIVE :
The objective of this study is to study the association between pre- and postoperative nutrition status compared with postoperative complications and surgical outcome. The results of this study may affect future nutrition practices and encourage different behaviors in gastrointestinal cancer patients who prepare to undergo surgery.
Sample size is calculated by n=(z_(1-α/2)^2 p(1-p))/d^2
Proportion (p) = 0.80, Error (d) = 0.064 Alpha (α) = 0.05, Z(0.975) = 1.959964 Power = 0.80 Sample size (n) = 178 Include drop out 10 % = 196 patients
Patients:
For 196 gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery. Every patient underwent nutritional assessment by NAF before surgery and (1 \& 3 months) after surgery at in the Department of Surgery, Ramathibodi Hospital and Buriram Hospital from 20 November 2018. Patients with incomplete documents were excluded from this study.
DATA COLLECTION AND DATA ANALYSIS:
- Pre-operative nutrition status assess by NAF
- Post-operative nutrition status at 1 month and 3 months assess by NAF
- All postoperative complications were collected according to Clavin-Dindo Classification8
- All case were included in this study, following TNM staging and others pathologic parameters :
- Cancer type - Tumor grading
- Lymph node metastasis - Tumor depth
- Conditions
- Digestive System Cancer
- Keywords
- Perioperative Nutritional Status, Surgical Outcome in Digestive System Cancer
- Medical subject headings
- Digestive System Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
The complication were collected according to Clavin-Dindo Classification
Measured: 1 month
postoperative complications
The complication were collected according to Clavin-Dindo Classification
Measured: 3 month
Secondary outcomes (2)
operative nutrition status
operative nutrition status assess by Nutrition Alert Form (NAF)
Measured: 1 month
operative nutrition status
operative nutrition assess by Nutrition Alert Form (NAF)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start20 Dec 2018
- Primary completion1 Apr 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System CancerStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chairat Supsamutchai, MD, Study chair, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763526
- Sponsor's protocol ID
- 2018/526
- Status last verified
- Sep 2021
- First submitted
- 3 Dec 2018
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients
- ClinicalTrials.gov ID
- NCT03763526
- Acronym / sponsor ID
- 2018/526
- Conditions
- Digestive System Cancer
- Keywords
- Perioperative Nutritional Status, Surgical Outcome in Digestive System Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 4 Dec 2018 (actual)
- 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.
Malnutrition is a common problem in cancer patients. It negatively influences patients' prognosis and quality of life. In gastrointestinal patients, it is also caused by insufficient food intake due to dysphagia, lack of appetite, nausea, vomiting, impaired digestion and absorption.
Furthermore, influence of prior oncologic treatment (surgery, chemotherapy, and radiotherapy), have been associated with prolonged hospital stay, more postoperative complications and low survival outcome1-4. So, the proper assessment of nutrition status to detect perioperative malnutrition may allow appropriate nutritional therapy and improve survival5.
However, the important factor which prolongs survival rate is good preoperative nutrition status because it effects the postoperative nutrition outcome. The objective of this study is to correlate the association between pre- and postoperative nutrition status and surgical outcomes.
The Nutrition Alert Form (NAF) is a clinical tool for determining nutritional status. The NAF was modified from Subjective Global Assessment (SGA)6, and it is easy to use and does not require nutritional expertise based on laboratory and physical examination. Therefore, the NAF has been used extensively for screening of malnutrition in hospitalized Thai patients and it can classify the nutritional status into three groups : NAF-A (Normal-Mild malnutrition), NAF-B (Moderate malnutrition), NAF-C (Severe malnutrition)
Detailed description
Primary Questions
- What is the relationship between the preoperative nutrition status and the postoperative nutrition status in gastrointestinal cancer patients ?
Secondary Questions
- What is the relationship between malnutrition during preoperative and postoperative stages, compared with postoperative complications?
OBJECTIVE :
The objective of this study is to study the association between pre- and postoperative nutrition status compared with postoperative complications and surgical outcome. The results of this study may affect future nutrition practices and encourage different behaviors in gastrointestinal cancer patients who prepare to undergo surgery.
Sample size is calculated by n=(z_(1-α/2)^2 p(1-p))/d^2
Proportion (p) = 0.80, Error (d) = 0.064 Alpha (α) = 0.05, Z(0.975) = 1.959964 Power = 0.80 Sample size (n) = 178 Include drop out 10 % = 196 patients
Patients:
For 196 gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery. Every patient underwent nutritional assessment by NAF before surgery and (1 \& 3 months) after surgery at in the Department of Surgery, Ramathibodi Hospital and Buriram Hospital from 20 November 2018. Patients with incomplete documents were excluded from this study.
DATA COLLECTION AND DATA ANALYSIS:
- Pre-operative nutrition status assess by NAF
- Post-operative nutrition status at 1 month and 3 months assess by NAF
- All postoperative complications were collected according to Clavin-Dindo Classification8
- All case were included in this study, following TNM staging and others pathologic parameters :
- Cancer type - Tumor grading
- Lymph node metastasis - Tumor depth
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery.
Key inclusion criteria (2 listed)
- All patients GI cancer
- Elective surgery
Key exclusion criteria (3 listed)
- Lack of oncologic treatment information before surgery
- No history of recurrent cancer or more than one cancer disease
- Patients who have been diagnosed with Carcinomatosis peritonei during the operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative complications
Time frame: 1 month
The complication were collected according to Clavin-Dindo Classification
postoperative complications
Time frame: 3 month
The complication were collected according to Clavin-Dindo Classification
2 secondary outcomes
operative nutrition status
Time frame: 1 month
operative nutrition status
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Chairat Supsamutchai, MD study chair
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Cancer, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Sep 2021. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative complications (time frame: 1 month). The study lists 2 primary outcomes in all. 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 2 Sep 2021.