Quality of Life After Rectal Cancer Surgery

Republic of Turkey Ministry of Health

Status

Completed

Conditions

Quality of Life

Rectal Cancer

Treatments

Procedure: Laparoscopic Rectal cancer surgery

Procedure: Open Rectal cancer surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04455945

2017/514/108/12

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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