Effect of inhalation of hydrogen gas on postoperative recovery

JRCT ID: jRCTs032200332

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatobiliary diseases
• Date of first enrollment: 29/01/2021
• Target sample size: 68
• Study type: Interventional
• Intervention(s): inhalation of hydrogen gas

Outcome(s)

• Primary Outcome: QoR40 of postoperative day 3

Secondary Outcome

1. QoR40 except postoperative day3
2. Postoperative complications (Clavien-Dindo score)
3. Wound pain (NRS)
4. Dietary intake
5. The number of steps taken
6. Inflammatory response (WBC, CRP, neutrophils, lymphocyte, IFN-gamma, IL-6, TNF-arpha)
7. Live functions (T-BIL, AST, ALT, ALP, Albumin, thrombocyte, PT, ICG)
8. Reactive oxygen value (urinary 8-OHdG)
9. adverse event
10. time of inhalation of hydrogen gas

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 20 years old and elder (regardless of gender)
2. Patient who undergone hepatic resection for hepatobiliary cancer (regrdless of operative procedure, range of hepatectomy and peimary disease)
3. patient who accept entry to this study with free will after sufficient exposition

Exclude criteria

1. Severe liver dysfunction or severe renal dysfunction
2. Uncontrollable diabetes mellitus
3. Pregnancy or possibility of being pregnant
4. Lactating patient
5. Patient who received another test agent or investigational agent within three months prior to agreement for this study
6. Patient who require combined other organ resection (Stomach, Colon, Lung and so on)
7. Patient who required biliary tract reconstruction
8. Patient who required emergency surgery (HCC rupture)
9. Patient who is considered as inadequate by principal investigator of this study

Related Information

• Primary Sponsor: Kaibori Masaki
• Source(s) of Monetary Support: Helix Japan