UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021752 |
|---|---|
| Receipt number | R000025083 |
| Scientific Title | Questionnaire for cosmetic outcomes in laparoscopic colectomy |
| Date of disclosure of the study information | 2016/04/02 |
| Last modified on | 2026/01/22 10:56:29 |
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Basic information
Public title
Questionnaire for cosmetic outcomes in laparoscopic colectomy
Acronym
Questionnaire for cosmetic outcomes
Scientific Title
Questionnaire for cosmetic outcomes in laparoscopic colectomy
Scientific Title:Acronym
Questionnaire for cosmetic outcomes
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the cosmetic outcomes of single-site laparoscopic colectomy (SLC) compared to conventional multiport laparoscopic colectomy (MLC) for colon cancer.
Basic objectives2
Others
Basic objectives -Others
To assess the difference of consciousness for cosmetic outcomes between people in general and medical workers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of bodily injury, self-consciousness and distress was evaluated using the VAS scale for comparison of SLC versus MLC.
Key secondary outcomes
Points for curability, safety, cosmetic outcomes, pain and hospitalization in colectomy for colon cancer will be given by people in general to assess the importance of cosmetic outcomes.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
At least 30 males and 30 females in each age group are required for statistical analyses. Therefore a total of more than 500 people will be collected.
Key exclusion criteria
There is no exclusion criteria.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Mori |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, E-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
mmori@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
S-1, W-17, Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111
Homepage URL
itakemasa@sapmed.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Osaka National Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/aosopen/fulltext/2024/09000/questionnaire_to_survey_cosmetic_outcomes_in.8.
Number of participants that the trial has enrolled
1352
Results
Curability had the highest score (49.9 53.7 points), followed by safety (23.8 24.7 points). The scores for cosmetic outcomes (6.2 7.1 points) were almost equal to those of the length of hospital stay (6.2 7.1 points), which was associated with medical costs and pain (10.0 11.1 points), one of the main reasons for fear of surgery. Participants who were female, younger, and in the nonmedical group placed great importance on cosmetic outcomes.
Results date posted
| 2026 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We used a web-based questionnaire to survey nonmedical and medical workers for what factors were considered on the
assumption that respondents undergo colorectal cancer surgery and that the most important person for them undergoes. Five items
(curability, safety, pain, length of hospital stay, and cosmetic outcomes) were compared. After paired photographs before and after
SLS and MLS were shown, perceptions of body image and cosmesis were assessed using a visual analog scale.
Participant flow
We used a web-based questionnaire to survey nonmedical and medical workers for what factors were considered on the
assumption that respondents undergo colorectal cancer surgery and that the most important person for them undergoes. Five items
(curability, safety, pain, length of hospital stay, and cosmetic outcomes) were compared. After paired photographs before and after
SLS and MLS were shown, perceptions of body image and cosmesis were assessed using a visual analog scale.
Adverse events
none
Outcome measures
The respondents were to assume that they and the most important person for them were undergoing surgery and rank the factors according to the importance of each outcome, with total scores summed to 100 points. The abdominal photographs of consecutive patients who underwent laparoscopic surgery for colorectal cancer at Osaka University, Sapporo Medical University, and National Hospital Organization Osaka National Hospital were collected to evaluate the differences in the perception of body image and cosmesis between SLS and MLS. A total of 32 patients photographs before and after surgery were used in this study (20 patients who underwent SLS and 12 patients who underwent MLS). Photographs of 1 patient before and after the surgery were grouped, and the pairs from SLS and MLS were randomly shown on the website. The perceptions of body image and cosmesis were assessed using a visual analog scale . The respondent was to assume the wound was theirs and answer previously reported questions with the following responses: dissatisfied with appearance, difficult to see self naked, less physically attractive, and body damage　from surgery.21 This study also added the following simple questions: Does the wound worry you? and Which age group is suitable for SLS? In addition, 3 questions compared SLS and MLS: Which wound is good-looking?, Which surgical procedure do you want to undergo?, and Which surgical procedure do you want for the most important person for you to undergo?
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the collection of cases, the questionnaire will be conducted.
Management information
Registered date
| 2016 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025083
