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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | The patients who undergo elective gastroenterological surgery with a class II (clean-contaminated) surgical wound | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | Midline abdominal wall incision closure with continuous sutures of fascia without peritoneum closure and continuous sutures of subcutaneous tissue
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 284 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |