NCT04455945

Quality of Life After Rectal Cancer Surgery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	Open Rectal cancer surgery	Open sphincter preserving surgery for rectal cancer
PROCEDURE	Laparoscopic Rectal cancer surgery	Laparoscopic sphincter preserving surgery for rectal cancer

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-31
• Completion: 2020-06-19
• First posted: 2020-07-02
• Last updated: 2020-07-02

Locations

1 site across 1 country: Turkey (Türkiye)