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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048442
Receipt No. 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 2022/07/25

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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 subcutaneous tissue
Interventions/Control_2 Midline abdominal wall incision closure with interrupted sutures for fascia together with peritoneum and interrupted sutures of subcutaneous 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
Email trikiyama@jichi.ac.jp

Public contact
Name of contact person
1st name Shota
Middle name
Last name Fukai
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
Email s08.086sf@jichi.ac.jp

Sponsor
Institute Saitama Medical Center, Jichi Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 23 Day
Date of IRB
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
2022 Year 07 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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