Quality of Life After Rectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
Following colorectal surgery, many patients face a combination of physical and emotional problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and sexual function, as well as problems in social and role functioning, inevitably affect the patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is becoming increasingly important in clinical trials. The investigators aimed to compare long term health related life quality (HRQoL) results of laparoscopic approach with open approach in patients with sphincter preserving resections for rectal cancer at a single-center.

Detailed Description
-----------------
This study is planned prospectively. All patients scheduled for operation due to rectal cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability for the study. During the preoperative examination, patients will be informed about the study and their written consent will be obtained. Patients will be randomized between open and laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of patients will be analyzed from the hospital database programme. The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients' daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the first year after surgery. In this way, it will be aimed to compare the early and long-term quality of life (HRQoL) results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.

Official Title
-----------------
Comparison of Quality of Life Outcomes Between Laparoscopic and Open Approach for Rectal Cancer Surgery

Conditions
-----------------
Rectal Cancer, Quality of Life

Intervention / Treatment
-----------------
* Procedure: Open Rectal cancer surgery
* Procedure: Laparoscopic Rectal cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent surgery (laparoscopic or open) for rectal cancer in our department. Exclusion Criteria: The patients whose all oncological treatments had not been completed at least 6 months ago The patients with ASA IV score The patients with previous abdominal surgery The patients who had developed major surgical complications (such as anastomosis leakage, requiring re-laparotomy, evisceration) The patients who underwent a new abdominal surgery except for stoma closure The patients with local recurrence or distant metastases The patients who still had a stoma The patients who did not want to take part in the study The patients who missed in the follow-up period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open<br>Patients with open surgery for rectal cancer planned in our department. | Procedure: Open Rectal cancer surgery<br>* Open sphincter preserving surgery for rectal cancer<br>|
| Laparoscopic<br>Patients with laparoscopic surgery for rectal cancer planned in our department. | Procedure: Laparoscopic Rectal cancer surgery<br>* Laparoscopic sphincter preserving surgery for rectal cancer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Years | Before surgery | 
| Gender | Male/Female | Before surgery | 
| BMI | kg/m² | Before surgery | 
| ASA | I, II, III, IV | Before surgery | 
| Tumor Localization | Upper/Middle/Low | During the operation | 
| Pathologic Stage | 1A, 1B, 2A, 2B, 3A, 3B, 3C | up to 10 days after surgery | 
| Complications | yes/no | Through study completion, an average of 1 year | 
| European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Functional scales | Global/Physical/Role/Cognitive/Social functioning. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning. | During one week after surgery | 
| European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Symptom scales | Fatigue/Nausea and vomiting/Pain/Dyspnoea/Insomnia/Appetite loss/Constipation/Diarrhoea/Financial difficulties. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level. | During one week after surgery | 
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Functional scales | Body Image/Future projections/Weight/Sexual interest. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning. | During one year after surgery | 
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Symptom scales | Urinary frequency/Blood and mucus in stool/Stool frequency/Urinary incontinence/Dysuria/Abdominal pain/Buttock pain/Bloating/Dry mouth/Hair loss/Taste/Flatulence/Faecal incontinence/Sore skin/Embarrassment/Impotence/Dyspareunia. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level. | During one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
life quality, rectal cancer surgery, questionnaire