UMIN-CTR Clinical Trial

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
Email	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
Email	a-matsu@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052969