Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Quality of Life

QLQ-C30 is the generic QOL tool for patients with cancer undergoing clinical trials.QLQ-STO22, containing 22 questions specific to gastric cancer, is currently the only standardized disease-specific questionnaire to measure the QOL of gastric cancer and must be used in conjunction with the QLQ-C30.MSK-10 consists of ten additional questions that were developed by surgeons on the GMT service to answer specific questions about outcomes related to proximal subtotal, distal subtotal, and total gastrectomies. These questions focus on eating capabilities, work status and major life changing events.

EORTC QLQ-C30, QLQ-STO22, and MSK-10

Daniel Coit, MD

The purpose of this study is to find out how you feel about the quality of your life after having had surgery to remove your stomach tumor. Some patients continue to experience different problems after stomach surgery, even when the surgery was more than three years ago. The purpose of this study is to find out the specific things that may continue to affect patients' quality of life after a major operation.

The purpose of this study is to measure the quality of life (QOL) of long-term survivors of resected gastric cancer. This cohort of long-term survivors will include patients who have no evidence of disease (NED) at least three years after having curative resection for gastric cancer. There are three main types of surgical procedures used to resect primary gastric cancer, which include proximal subtotal, distal subtotal, and total gastrectomy. Surgical management of gastric cancer at Memorial Sloan-Kettering Cancer Center (MSKCC) has shifted over the years to a greater use of proximal subtotal gastrectomies than in the past; however the effects on the QOL of these patients are unknown. In this study, we propose to use the European Organization for Research Treatment of Cancer (EORTC) two-part questionnaire QLQ-C30 and QLQ-STO22. This instrument has been shown to be a valid and reliable QOL instrument used to assess the quality of life of patients with gastric cancer.

We will measure multiple domains of QOL including, physical, role, cognitive, and emotional functions. An additional 10-item questionnaire (MSK-10) was designed by GMT service surgeons and will be administered in order to more specifically identify certain potential issues of QOL among gastric cancer survivors. These issues include eating capabilities, work status and major life changing events. Patients will be identified using the Gastric and Mixed Tumor (GMT) Service Gastric Cancer Database. The questionnaires will be conducted via telephone interview. Establishing these QOL measurements will help to provide valuable baseline data upon which to base future clinical trials of optimal surgical techniques.

OBJECTIVES AND SCIENTIFIC AIMS

* To establish health related QOL using the EORTC QLQ-C30 and QLQ-STO22 in gastric cancer patients who are alive and free of disease for three or more years after a proximal, distal, or total gastrectomy for gastric cancer.
* To compare the differences in QOL scores between the three different types of gastrectomy.
* To compare results using the EORTC QLQ-C30 with published norms established in the United States.
* To use the MSK-10 to assess the incidence and degree of certain areas of QOL that may affect gastric cancer survivors specifically.

Quality of Life Among Long-Term Survivors of Resected Gastric Cancer

Memorial Sloan Kettering Cancer Center

Coit, Daniel, MD / Pricipal Investigator

Skin and Connective Tissue Diseases

Colonic Neoplasms

Rectal Neoplasms

Gastrointestinal Stromal Tumors

Intestinal Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Colorectal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.

Wenceslao Vasquez Jimenez, Dr.

The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.

This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.

Gastrointestinal Anastomosis Using MonoPlus® Suture

Assessment of MonoPlus® Suture Material for Anastomosis in the Gastrointestinal Tract. A Prospective, Multi-centric, International, Single-arm, Observational Study in Daily Practice

The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery

Comparison of the dehiscence rate of the suture line at different postoperative examinations

Comparison of the Peritonitis rate of the suture line at different postoperative examinations

Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC) at different postoperative examinations.

Comparison of postoperative Bleeding rate at different postoperative examinations

Comparison of postoperative Abscess rate at different postoperative examinations

Comparison of postoperative Fistula rate at different postoperative examinations

Comparison of postoperative Perforation rate at different postoperative examinations

Comparison of postoperative Obstipation rate at different postoperative examinations

Comparison of postoperative Stenosis rate at different postoperative examinations

Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations

Comparison of postoperative Mortality rate at different postoperative examinations

Comparison of postoperative Stoma rate at different postoperative examinations

Number of days between date of surgery and date of discharge

Number of days the patient has to stay in the intensive care unit after the intervention

Time in Minutes the surgeon needs to perform the anastomosis

EQ-5D-5L is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"

This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain". The values are compared over postoperative period.

Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, stiffness) with 5 evaluation levels (excellent, very good, good, satisfied, poor).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life Among Long-Term Survivors of Resected Gastric Cancer	NCT00598546	Gastric Cancer	EORTC QLQ-C30, ...	18 Years -	Memorial Sloan Kettering Cancer Center
Gastrointestinal Anastomosis Using MonoPlus® Suture	NCT04811833	Gastrointestina... Gastrointestina... Digestive Syste... Stomach Tumor Small Intestine... Colon Tumor Rectum Tumor		18 Years -	Aesculap AG
Gastrointestinal Anastomosis Using MonoPlus® Suture	NCT04811833	Gastrointestina... Gastrointestina... Digestive Syste... Stomach Tumor Small Intestine... Colon Tumor Rectum Tumor		18 Years -	Aesculap AG

Spots Global Cancer Trial Database for stomach tumor