UMIN-CTR Clinical Trial

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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