UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046463 |
|---|---|
| Receipt number | R000052969 |
| Scientific Title | A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic rectal surgery using an adhesion barrier material (Seprafilm) |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/06/27 09:54:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic rectal surgery using an adhesion barrier material (Seprafilm)
Acronym
BALSAM 2 study
Scientific Title
A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic rectal surgery using an adhesion barrier material (Seprafilm)
Scientific Title:Acronym
BALSAM 2 study
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will assess the clinical utility of Seprafilm for the prevention of small bowel obstruction after ileostomy reversal in cases of laparoscopic rectal cancer surgery with diverting ileostomy creation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative small bowel obstruction 2 years after ileostomy reversal
Key secondary outcomes
Base
Study type
Observational
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A) Histologically confirmed stage I-III rectal carcinoma
B) Without metastasis and/or invasion of adjacent organs
C) Laparoscopic or robotic surgery performed
D) Curative surgery performed
E) Using anti-adhesion barriers (Seprafilm, Interceed, and Adspray) during rectal cancersurgery
F) Patient with age between 20 and 80 years
G) Any intervals between initial surgery (rectal cancer surgery) and ileostomy reversal
H) Patient with an Eastern Cooperative Oncology GroupPerformance Status of 0 or 1
I) Exhibiting sufficient organ function within 1 month prior to enrollment in the study with the following parameters considered:
-White blood cell count: 3,000/mm3 or higher
-Platelet count: 75,000/mm3 or higher
-Hemoglobin: 8.0 g/dl or higher
-Serum AST and ALT: 2.5 times or less than the upper limit of the institutional reference value
-Serum total bilirubin: less than 1.5 mg/dl
-Serum creatinine: 1.5 mg/dl or less
Key exclusion criteria
A) Contraindications for Seprafilm use
B) History of previous abdominal surgery, except for appendectomy, laparoscopic cholecystectomy, and cesarean section performed >5 years prior
C) Cases of small bowel obstruction prior to ileostomy reversal
D) The treating physician did not feel that the use of Seprafilm was appropriate
Target sample size
275
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamada |
Organization
Nippon Medical School
Division name
Department of Gastrointestinal Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
y-tak@nms.ac.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Matsuda |
Organization
Nippon Medical School Hospital
Division name
Department of Gastrointestinal Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
+81-3-3822-2131
Homepage URL
a-matsu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nippon Medical School
Address
Nippon Medical School Hospital
Tel
+81-3-3822-2131
nms_fuzokurinri@nms.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 | 01 | 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
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052969
