Analysis of patient satisfaction parameters in conventional versus minimally invasive surgery for rectal, pancreatic, and esophageal cancer in surgery
Organizational Data
- DRKS-ID:
- DRKS00028510
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-04-01
- Last update in DRKS:
- 2023-05-12
- Registration type:
- Prospective
Acronym/abbreviation of the study
PAZUKOMO
URL of the study
No Entry
Brief summary in lay language
Surgery often plays a major role in the treatment of abdominal cancer. There are open and minimally invasive abdominal surgery. Depending on the conditions of the individual case, the most suitable surgical method for the patient is selected. The study should contribute to finding out how and by what means operated patients would be satisfied or more satisfied. Furthermore, it is to be determined whether there is a difference in satisfaction depending on the surgical method.
Brief summary in scientific language
The study described here is a monocentric cross-sectional study. In two separate parts of the study, structured, standardized interviews will be conducted with patients undergoing elective open or minimally invasive pancreatic, esophageal, or rectal tumor surgery. In these interviews parameters of patient satisfaction are to be qualitatively elaborated. Topics such as medical-oncological care will be surveyed. In this context, for example, the medical quality perceived by the patient, postoperative pain, the cosmetic result, long-term survival or permanent disabilities are of relevance. Another topic to be examined will be the socio-demographic background of the patient, (age, education, or economic circumstances). In the second part of the study, questionnaires will be designed on the basis of the qualitative parameters and answered by patients (quantitative part). The questions designed for this purpose will be derived from the focal points named by patients in the qualitative part.
Health condition or problem studied
- ICD10:
- C20 - Malignant neoplasm of rectum
- ICD10:
- C15 - Malignant neoplasm of oesophagus
- ICD10:
- C25 - Malignant neoplasm of pancreas
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients with rectal, esophageal, or pancreatic cancer who receive conservative or minimally invasive surgery are interviewed about their satisfaction pre- and postoperatively using a questionnaire. To develop the questionnaire, a qualitative assessment will first be conducted to clarify possible foci in satisfaction or dissatisfaction as well as patients' understanding of the disease.
Endpoints
- Primary outcome:
- This is a qualitative pilot study with a quantitative component and no defined primary endpoint. The aim of the study is to analyze which conditions would have to exist for patients operated in the clinic to be satisfied or more satisfied with the course of treatment and its results, and to gain insight into which factors positively or negatively influence patient satisfaction.
- Secondary outcome:
- This is a qualitative pilot study with a quantitative component and no defined secondary endpoint. Through this study, it is conceivable to derive improvements for certain clinical procedures in the future.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Carl Gustav Carus Dresden Dresden
Recruitment period and number of participants
- Planned study start date:
- 2023-04-14
- Actual study start date:
- 2023-05-10
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Patients undergoing open or minimally invasive (including roboter-assisted) pancreatic, esophageal, or rectal surgery for a tumor condition at VTG-Surgery. - Patients with conversion from minimally invasive to open surgery are also included and studied separately as a subgroup - written informed consent - understanding of the German language
Exclusion Criteria
- Emergency patients - Speech problems or impaired mental status - Lack of compliance
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität DresdenKlinik und Poliklinik für Viszeral-, Thorax- und GefäßchirurgieFetscherstraße 7401307 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Uniklinikum Dresden, Klinik für Viszeral-, Thorax- und GefäßchirurgieDr. med. Olga Radulova-MauersbergerFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49 (0)351 458 4098
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://ukdd.de
Contact for Public Queries
- Address:
- Uniklinikum Dresden, Klinik für Viszeral-, Thorax- und GefäßchirurgieDr. med. Olga Radulova-MauersbergerFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49 (0)351 458 4098
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://ukdd.de
Principal Investigator
- Address:
- Uniklinikum Dresden, Klinik für Viszeral-, Thorax- und GefäßchirurgieDr. med. Olga Radulova-MauersbergerFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49 (0)351 458 4098
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://ukdd.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität Dresden Klinik und Poliklinik für Viszeral-, Thorax- und GefäßchirurgieFetscherstraße 7401307 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der TU DresdenFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-4582992
- Fax:
- +49-351-4584369
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-03-09
- Ethics committee number:
- BO-EK-121032022
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-03-24
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry