Association Between Perioperative Nutritional Status and Surgical Outcome in Digestive System Cancer Patients

NCT03763526 | Completed

• 1 other identifier: 2018/526
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Digestive System Cancer

Keywords

Perioperative Nutritional Status; Surgical Outcome in Digestive System Cancer

Outcome Measures

Primary Outcomes (2)

• postoperative complications

  The complication were collected according to Clavin-Dindo Classification

  1 month

• postoperative complications

  The complication were collected according to Clavin-Dindo Classification

  3 month

Secondary Outcomes (2)

• operative nutrition status

  1 month

• operative nutrition status

  3 month

Other Outcomes (1)

• Length of hospital stay

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

gastrointestinal cancer patients (esophageal, gastric, colon and rectum cancer), who underwent scheduled surgery.

You may qualify if:

• All patients GI cancer
• Elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Chairat Supsamutchai, MD

  Ramathibodi Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: December 20, 2018
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

TH (1)