臨床研究等提出・公開システム

Date of registration	July. 06, 2026
Last modified on	July. 06, 2026
Trial ID	jRCT1030260285

Scientific Title	Study on patient exposure to surgical smoke during cesarean section
Public Title	Study on the effects of surgical smoke on patients during cesarean section

Contact for Scientific Queries	Name	Asai Takashi
	Affiliation	Dokkyo Medical University Saitama Medical Center
	Address	2-1-50 Minamikoshigaya,Koshigaya-shi,Saitama-ken
	Telephone	+81-80-2247-8259
	E-mail	s-kurumada@dokkyomed.ac.jp
Contact for Public Queries	Name	Kurumada Shintaro
	Affiliation	Dokkyo Medical University Saitama Medical Center
	Address	2-1-50 Minamikoshigaya,Koshigaya-shi,Saitama-ken
	Telephone	+81-48-965-1111
	E-mail	s-kurumada@dokkyomed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 26, 2026
Actual date of first enrollment		May. 01, 2026
Target sample size		60
Study Type		Observational
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Cesarean section using energy device
	Exclusion Criteria	Patients who underwent cesarean section under general anesthesia Patients undergoing emergency cesarean section
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Cesarean section using energy device
Intervention(s)		Control group:No intervention. Drape group:A drape measuring 2m in height and 2m in width was placed between the surgical field and the patient's head before the use of the electrosurgical device.
Primary Outcome(s)		Air particle counts
Secondary Outcome(s)		Odor score

Primary Sponsor	None

Name of Certified Review Board	Clinical Research Ethics Review Committee,Saitama Medical Center,Dokkyo Medical University
Address	2-1-50 Minamikoshigaya,Koshigaya-shi,Saitama-ken,Saitama, Saitama
Telephone	+81-48-965-1111
E-Mail	k-shien@dokkyomed.ac.jp
Approval Status	Approval
Date of approval	Mar. 26, 2026

Plan to share IPD	No

Secondary ID(s)	なし

Countries of Recruitment（Except Japan）	none