Quality of Life After Rectal Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-06-19

Brief Summary

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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.

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Detailed Description

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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

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Rectal Cancer Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open

Patients with open surgery for rectal cancer planned in our department.

Open Rectal cancer surgery

Intervention Type PROCEDURE

Open sphincter preserving surgery for rectal cancer

Laparoscopic

Patients with laparoscopic surgery for rectal cancer planned in our department.

Laparoscopic Rectal cancer surgery

Intervention Type PROCEDURE

Laparoscopic sphincter preserving surgery for rectal cancer

Interventions

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Open Rectal cancer surgery

Open sphincter preserving surgery for rectal cancer

Intervention Type PROCEDURE

Laparoscopic Rectal cancer surgery

Laparoscopic sphincter preserving surgery for rectal cancer

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No