Trial document




drksid header

  DRKS00014381

Trial Description

start of 1:1-Block title

Title

Quality of Life in patients with colon carcinoma after hemicolectomy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

DarmLQ

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Colorectal carcinoma is the third most common malignant tumor in western countries. Changes in bowel anatomy after colon resection can lead to a number of dysfunctions that may be of long-term importance to the patient, such as bowel dysfunction, pain, fatigue, subjective well-being, and psychological stress. Therefore, patients' quality of life is becoming more and more important as a measure of successful treatment. The aim of this study is therefore to analyze the quality of life of patients with colon carcinoma after hemicolectomy using the following hypotheses:
o In the long term, patients recovering from hemicolectomy without postoperative complications recover very well overall and achieve a good quality of life.
o Regarding quality of life, there is no significant difference in patients with hemicolectomy left or right.
o Due to the comorbidities, older patients are expected to have more difficulty restoring a generally good quality of life postoperatively than younger patients.

These hypotheses will be reviewed by a retrospective analysis (01/2010 to 12/2017) of patients with colon cancer surgically treated in the Pius Hospital Oldenburg. All patients of the Colorectal Cancer Center who meet the inclusion criteria of this study will be informed and will be asked by mail to complete the EORTC C-30 questionnaire after obtaining their consent.The Pius Hospital Oldenburg is committed within the framework of quality assurance to maintain this database since 2010. It contains more than 800 patients, of whom approximately 300 meet the inclusion criteria after a first review. Those patients will be contacted regarding the inclusion into this study.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Colorectal carcinoma is the third most common malignant tumor in western countries [1, 2]. According to the Center for Cancer Data of the Robert Koch Institute, the number of new cases for men is around 33,000 and for women around 28,000 every year (as of 2014). The relative 5-year survival is given as 62% for men and 63% for women. Colon carcinoma is a disease that primarily affects the older generation. Over 50% of those affected become ill after the age of 70. After all, 10% of colorectal cancers are diagnosed before the age of 55 years [3]. An operative procedure remains the most common treatment option [1]. Due to advances in technology in medicine and the widely established preventive care programs for colorectal cancer in Germany, tumors are diagnosed earlier and mortality is reduced [1, 4].
However, the change in bowel anatomy after colon resection can lead to a number of dysfunctions that may be of long-term importance to the patient, such as bowel dysfunction, pain, fatigue, subjective well-being, and psychological stress. Therefore, patients' quality of life is becoming more and more important as a measure of successful treatment [1, 5]. Patients want to be prepared for the quality of their life expectancy postoperatively [1].
The aim of this study is to "analyze the quality of life of patients with colon carcinoma after hemicolectomy."
Based on the literature review to date, it can be seen that there are hardly any data on the long-term quality of life of patients with colon carcinoma treated surgically. On the other hand, there are numerous studies that report on bowel, urinary and sexual dysfunction after rectal cancer treatment [5-8] and have analyzed the importance of a stoma for quality of life [9]. In recent years, additional studies have been undertaken to examine patients with colorectal cancer for their quality of life. However, the study period in the most prospective studies barely exceeded a period of one year postoperatively. Another problem is the large number of quality of life measuring instruments used in cancer patients. In 2014, Thedoropoulus and Karantanos published a review of the analysis of literature questionnaires used to measure the quality of life after laparoscopic colectomy in colorectal cancer. In the 20 included studies, 9 different questionnaires were used, some of which were not widely validated [1]. These problems lead to the following questions, which should be dealt with in this study:
o What is the quality of life of patients of the Pius Hospital Oldenburg with colon cancer in general?
o How is the course of the quality of life after the operative therapy?
o Is there a long-term difference between the quality of life of patients after a right hemicolocetomy and a left hemicolectomy?
o Are there sociodemographic, clinical or laboratory characteristics that have a significant impact on the postoperative quality of life of patients with colon carcinoma?

In December 2016, Adela Brigic et al. published a study that was first known to me to compare the quality of life of patients with hemicolectomy right and left over a period of one year postoperatively. The data are from patients in the United Kingdom. However, the focus of this study was mainly on bowel motility and stool frequency. Quality of life was measured by the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L), which can assess the overall quality of life of patients with independent disease. The authors found no significant difference in quality of life between the two patient populations. In addition, after one year postoperatively there was no difference in quality of life between the entire patient population and a healthy control group. [5, 10]
Since there is also a high standard of medical practice in surgical hemicolectomy in Germany, I assume that in my study I can record similarly good results with regard to the long-term quality of life of patients in the Pius Hospital Oldenburg. Based on the data from this study and the comparative study by Theodoropoulus and Karanthos, the following hypothesis are investigated in this study:
o Regarding quality of life, there is no significant difference in patients with hemicolectomy left or right.
o In the long term, patients recovering from hemicolectomy without postoperative complications recover very well overall and achieve a good quality of life.
o Due to the comorbidities, older patients are expected to have more difficulty restoring a generally good quality of life postoperatively than younger patients.
These hypotheses will be reviewed by interviewing all patients treated with hemicolectomy right or left between 1/2010 and 12/2017 by post using the EORTC C30 questionnaire on their current quality of life.
Literature:
1. Theodoropoulos, G.E. and T. Karantanos, Quality of life after laparoscopic colectomy for cancer. JSLS, 2014. 18(2): p. 225-35.
2. Greenlee, R.T., et al., Cancer statistics, 2001. CA Cancer J Clin, 2001. 51(1): p. 15-36.
3. Krebs in Deutschland für 2013/2014. Vol. 11. 2017, Berlin: Robert Koch-Institut (Hrsg) und die Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. (Hrsg).
4. Becker, N., J.E. Muscat, and E.L. Wynder, Cancer mortality in the United States and Germany. J Cancer Res Clin Oncol, 2001. 127(5): p. 293-300.
5. Brigic, A., et al., A prospective case control study of functional outcomes and related quality of life after colectomy for neoplasia. Int J Colorectal Dis, 2017. 32(6): p. 777-787.
6. Peeters, K.C., et al., Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients--a Dutch colorectal cancer group study. J Clin Oncol, 2005. 23(25): p. 6199-206.
7. Ramsey, S.D., et al., Quality of life in long term survivors of colorectal cancer. Am J Gastroenterol, 2002. 97(5): p. 1228-34.
8. Vironen, J.H., et al., Impact of functional results on quality of life after rectal cancer surgery. Dis Colon Rectum, 2006. 49(5): p. 568-78.
9. Gavaruzzi, T., et al., Quality of life after surgery for rectal cancer. Recent Results Cancer Res, 2014. 203: p. 117-49.
10. EQ-5D-3L. [cited 2017 06.02]; Available from: https://heartbeat-med.de/proms/eq-5d-3l-eq-vas-score/.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014381
  •   2018/04/16
  •   [---]*
  •   yes
  •   Approved
  •   2018-010, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Prospective analysis of the current quality of life of patients treated with rigthsided hemicolectomy at the Pius Hospital Oldenburg between 01/2010 and 12/2017 using the EORTC C30 questionnaire in June / July 2018
  •   Prospective analysis of the current quality of life of patients treated with leftsided hemicolectomy at the Pius Hospital Oldenburg between 01/2010 and 12/2017 using the EORTC C30 questionnaire in June / July 2018
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Comparison of the current quality of life in patients with leftsided and rightsided hemicolectomy (operated between 1/2010 and 12/2017 at the Pius Hospital Oldenburg) measured by the EORTC-C30 questionnaire

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Quality of life measured using the EORTC-C30 questionnaire for patients with different time intervals between surgery and time of interview.
- Quality of life measured using the EORTC-C30 questionnaire as a function of age, gender, UICC (Union for International Cancer Control) stage and other relevant parameters collected in the context of clinical care.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/05/01
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Age of Consent
• patients with colon carcinoma treated surgically in the Pius Hospital Oldenburg between 1/2010 und 12/2017
• elective (extended) right hemicolectomy (cecum, ascending colon, transverse colon)
• elective (extended) left hemicolectomy (descending colon, sigmoid colon / high anterior resection)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Patients younger than 18 years
• lack of knowledge of German
• Disability of the patient
• Refusal to participate in the study
• Inflammatory bowel disease
• celiac Disease
• rectal carcinoma
• Radiation therapy in the pelvis before hemicolectomy
• Previous gastrointestinal resections prior to hemicolectomy
• vagotomy
• emergency colectomy
• Stoma present at the time of the survey
• Recurring carcinoma
• Diagnosed incontinence before hemicolectomy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Mr.  Dr. med.  Dirk  Weyhe 
    • Georgstr. 12
    • 26121  Oldenburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Ms.  Dr. rer. nat  Verena Nicole  Uslar 
    • Georgstr. 12
    • 26121  Oldenurg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Ms.  Dr. rer. nat  Verena Nicole  Uslar 
    • Georgstr. 12
    • 26121  Oldenurg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Mr.  Dr. med.  Dirk  Weyhe 
    • Georgstr. 12
    • 26121  Oldenburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/10/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.