Quality of Life After Rectal Cancer Surgery

July 1, 2020 updated by: Ramazan Sari, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34890
        • Kartal Dr Lutfi Kirdar Tranining and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients who underwent surgery (laparoscopic or open) for rectal cancer in our department.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open
Patients with open surgery for rectal cancer planned in our department.
Procedure: Open Rectal cancer surgery
Open sphincter preserving surgery for rectal cancer
Laparoscopic
Patients with laparoscopic surgery for rectal cancer planned in our department.
Procedure: Laparoscopic Rectal cancer surgery
Laparoscopic sphincter preserving surgery for rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Before surgery
Years
Before surgery
Gender
Time Frame: Before surgery
Male/Female
Before surgery
BMI
Time Frame: Before surgery
kg/m²
Before surgery
ASA
Time Frame: Before surgery
I, II, III, IV
Before surgery
Tumor Localization
Time Frame: During the operation
Upper/Middle/Low
During the operation
Pathologic Stage
Time Frame: up to 10 days after surgery
1A, 1B, 2A, 2B, 3A, 3B, 3C
up to 10 days after surgery
Complications
Time Frame: Through study completion, an average of 1 year
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
Time Frame: During one week after surgery
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
Time Frame: During one week after surgery
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
Time Frame: During one year after surgery
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
Time Frame: During one year after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

  • Study Chair: Selcuk Kaya, MD, Kartal Dr. Lutfi Kirdar Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

June 19, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/514/108/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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