Oral rehydration therapy containing protein

JRCT ID: jRCT1021220044

Registered date:28/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Elective surgery for lobectomy or segmental resection, which is standard surgery for pulmonary malig
• Date of first enrollment: 01/01/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

From February 2023, 22 bottles (400 ml) of Isocalclear, an oral fluid replacement preparation containing protein, will be provided to patients admitted to the Department of Thoracic Surgery at our hospital and undergoing surgery in the lobectomy pass (lobectomy or zonal resection).
For surgery in the morning: 2 bottles are taken from after waking up on the day of surgery to 2 hours before surgery.
In the case of surgery in the afternoon: One bottle is taken from after waking up on the day of surgery until 7 a.m., and one bottle is taken in two doses from 7 a.m. to 2 hours before surgery.

Outcome(s)

• Primary Outcome: Preoperative Oral Rehydration Therapy The main purpose of this study is to clarify whether preoperative oral rehydration solutions containing proteins can be used safely. Gastric excretion is delayed if protein is included, and there is a risk of vomiting if there is a large amount of gastric residue from the time of induction of anesthesia to after surgery.

Secondary Outcome

Item in conjunction with nourishment such as the blood urine
Item about the nourishment such as physical measurements
It is complications hospitalization after the operation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Age is 18 years or older
The patient who receives an elective surgery (the lobe of the lung excision that is the standard operation of the pulmonary malignant tumor or area excision) in our hospital respiratory organs surgery

Exclude criteria

The patients with dysphagia
The patient that an absorption disorder is expected for severe gastrointestinal dysfunction, the stomach and intestines pro-operation past
Adaptation patient of the emergency surgery
The patients with allergy to milk
The patient that water was judged to be inappropriate in preoperation

Related Information

• Primary Sponsor: Suzuki Hiroyuki