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OpenTrials
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NCT Number: NCT04455945

Quality of Life After 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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kartal Dr Lutfi Kirdar Tranining and Research Hospital

Istanbul, 34890, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Rectal cancer surgery

Procedure

Open sphincter preserving surgery for rectal cancer

Laparoscopic Rectal cancer surgery

Procedure

Laparoscopic sphincter preserving surgery for rectal cancer

Primary outcomes

  1. Age

    Time frame: Before surgery

    Years

  2. Gender

    Time frame: Before surgery

    Male/Female

  3. BMI

    Time frame: Before surgery

    kg/m²

  4. ASA

    Time frame: Before surgery

    I, II, III, IV

  5. Tumor Localization

    Time frame: During the operation

    Upper/Middle/Low

  6. Pathologic Stage

    Time frame: up to 10 days after surgery

    1A, 1B, 2A, 2B, 3A, 3B, 3C

  7. Complications

    Time frame: Through study completion, an average of 1 year

    yes/no

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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