UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048442 |
|---|---|
| Receipt number | R000055205 |
| Scientific Title | The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/01/23 12:39:31 |
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Basic information
Public title
The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery
Acronym
The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery
Scientific Title
The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery
Scientific Title:Acronym
The development of a midline abdominal wall incision closure technique to reduce the incidence of wound complications after elective gastroenterological surgery
Region
| Japan |
Condition
Condition
The patients who undergo elective gastroenterological surgery with a class II (clean-contaminated) surgical wound
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the superiority of the combination of continuous sutures of fascia without peritoneum closure and continuous sutures of subcutaneous tissue over that of interrupted sutures for fascia together with peritoneum and interrupted sutures of subcutaneous tissue for reducing the incidence of wound complications of midline abdominal wall incision after elective gastroenterological surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative wound complications, including wound bleeding, hematoma, surgical site infection, seroma and wound dehiscence within 30 days after surgery, and incisional hernia within 1 year after surgery
Key secondary outcomes
Duration of abdominal wall closure and wound pain seven days after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Midline abdominal wall incision closure with continuous sutures of fascia without peritoneum closure and continuous sutures of subcuticular tissue
Interventions/Control_2
Midline abdominal wall incision closure with interrupted sutures for fascia together with peritoneum and interrupted sutures of subcuticular tissue
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Scheduled to undergo elective surgery for esophagus, stomach, duodenum, jejunum, ileum, colorectal, pancreas, liver or biliary tract with a class II (clean-contaminated) surgical wound
2 Age >= 18 years old at the time of consent being obtained by non-blinded investigators.
3 Scheduled to undergo computed tomography one year after surgery
4 Written informed consent provided
Key exclusion criteria
1 Emergency surgery
2 Under 18 years old
3 A history of midline abdominal wall incision
4 A history of abdominal incisional hernia or fascial tear
5 Identification of bacterial infection in the surgical field or the use antibiotic therapy prior to the operation.
6 Presence of a contaminated abdominal cavity due to stoma, intestinal fistula or drainage tube.
7 Open wound management for prior operation.
8 Synchronous operation for more than two targeted organs.
9 Current immunotherapy (>= 40 mg of a corticosteroid per day or azathioprine)
10 Chemotherapy within 14 days prior to surgery
11 A history of radiotherapy of the abdomen
12 Pregnancy
13 Registered for another clinical trial
14 Conditions that make the patient unsuitable for inclusion according to the judgement of non-blinded investigators.
Target sample size
284
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Rikiyama |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Surgery
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya-ku, Saitama
TEL
0486472111
trikiyama@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mizusawa |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Surgery
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya-ku, Saitama
TEL
0486472111
Homepage URL
yuki.afterdark@gmail.com
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
The Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University
Address
1-847, Amanuma-cho, Omiya-ku, Saitama
Tel
0486472111
s-suishin@jichi.ac.jp
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
| 2022 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
Yes
IPD sharing Plan description
Immediately after the publication of the primary results, de-identified individual participant data that underlie the results reported in the article(s) and other documents (study protocol and statistical analysis plan) will be available for any purpose, only if approved by the Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University. Anyone who wishes to access the data should submit a proposal to s08.086sf@jichi.ac.jp. If approved, data requestors will need to sign a data access agreement. After that, the principal investigator will transfer the data and other documents to data requestors.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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