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Group of patients that are operated with laparoscopic approach

Group of patients operated with open approach

Laparoscopic colectomy. Epidural anaesthesia used

Laparoscopic colectomy

Open colectomy. Epidural anaesthesia used

Open colectomy

This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery

Inflammatory Response in Laparoscopic and Open Colectomy

Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery

University of Ioannina

G. Hatzikosta General Hospital

Konstantinos E. Tsimogiannis, MD

Nervous System Diseases

Behaviors and Mental Disorders

Peripheral Nervous System Diseases

Colonic Neoplasms

Quality of Life

Colon cancer survivors who undergo open or laparoscopic resection of their colon cancers followed by adjuvant chemotherapy.

Colon cancer survivors who undergo open or laparoscopic resection of their colon cancer and who do not receive chemotherapy.

Jeanne M Robison, PhD, ARNP

Mel Haberman, PhD, FAAN

The overall purpose of this study was to address the following questions by describing the trajectory of early survivorship in individuals who undergo both surgical and medical management of colon cancer. What are the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, following curative resection during the first year of treatment and recovery? Is there an interaction between exposures to chemotherapy and changes over time in these outcomes?

The population of interest included colon cancer survivors of both sexes, 18 to 90 years of age, who underwent one of two types of surgical resection and who may receive adjuvant chemotherapy. The prospective design with two cohorts representing exposure to chemotherapy (chemotherapy vs. no-chemotherapy) described the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, which occurred following curative resection. An analysis of the interaction between time (four measurement occasions) and the independent variable of chemotherapy group by mean values of quality of life, sexual function, peripheral neuropathy, and demands of illness addressed the central thesis question.

Specific Aims

1. Examine the relationships among quality of life, demands of illness, sexual functioning, and peripheral neuropathy, for the total sample and by chemotherapy group.
2. Examine changes within-subjects (four measurement occasions), between-group (chemotherapy, no-chemotherapy) differences, and the interaction between time and chemotherapy group for quality of life, demands of illness, sexual functioning, and peripheral neuropathy across four measurement occasions.

The Inland Northwest Colon Cancer Survivor's Study

Self Reported Changes in Quality of Life, Demands of Illness, and Sexual Function in Colon Cancer Survivors.

Psychometric analysis to evaluate the reliability and validity of the modified Neurotoxicity Sub-Scale.

The European Organization for Research and Treatment Quality of Life Questionnaire

The Neurotoxicity Sub-scale (Ntx-13); a questionnaire about symptoms of nerve damage in persons receiving chemotherapy, will be utilized to assess symptoms of neurologic toxicities in persons receiving the chemotherapy drug oxaliplatin. The interaction between time (four measurement occasions) and chemotherapy group (chemotherapy, no chemotherapy ) by mean values of peripheral neuropathy will be examined.

Change in Sexual Function Questionnaire (CSFQ)will be used to describe the changes in sexual function reported by cancer survivors following surgery and adjuvant chemotherapy. The interaction between time (four measurement occasions) and chemotherapy group (chemotherapy, no chemotherapy ) by mean values of changes in sexual function will be examined.

A short questionnaire regarding the use of educational and support materials related to colon cancer will be used to describe which materials persons with colon cancer utilize during the 8 months after diagnosis.

The Demands of Illness Inventory (DOII); a questionnaire about the stressors experienced by cancer survivors will be utilized for this outcome measure. The interaction between time (four measurement occasions) and chemotherapy group (chemotherapy, no chemotherapy ) by mean values from the demands of illness inventory will be examined.

American Cancer Society, Inc.

Washington State University

Procedure/Surgery: laparoscopic colectomy

open colectomy

laparoscopic colectomy

Seigo Kitano, MD, PhD,FACS

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)

Ministry of Health, Labour and Welfare, Japan

Haruhiko Fukuda

JCOG Data Center

Group of patients operated with open approach for colorectal cancer

Group of patients operated with laparoscopic approach for colorectal cancer

Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Inflammatory Response in Laparoscopic and Open Colectomy	NCT00942461	Colorectal Canc...	Laparoscopic co... Open colectomy	-	G. Hatzikosta General Hospital
The Inland Northwest Colon Cancer Survivor's Study	NCT01775254	Colon Cancer		18 Years -	Washington State University
A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer	NCT00147134	Colorectal Canc...	open colectomy laparoscopic co...	20 Years - 75 Years	Japan Clinical Oncology Group
Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer	NCT00928928	Colorectal Canc...	Open colectomy laparoscopic co...	-	G. Hatzikosta General Hospital
The Inland Northwest Colon Cancer Survivor's Study	NCT01775254	Colon Cancer		18 Years -	Washington State University
Inflammatory Response in Laparoscopic and Open Colectomy	NCT00942461	Colorectal Canc...	Laparoscopic co... Open colectomy	-	G. Hatzikosta General Hospital

Spots Global Cancer Trial Database for open colectomy