Tokyo, June 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062056) titled 'A Study of the Efficacy of Chukenchuto in Gynecologic Laparoscopic Surgery' on June 29.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Shizuoka City Shizuoka Hospital
Condition:
Condition - Postoperative Gastrointestinal Complications Following Gynecologic Laparoscopic Surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to evaluate the effects of Chukenchuto, a Kampo medicine, on postoperative abdominal symptoms and patient satisfaction in patients undergoing gynecologic laparoscopic surgery. By clarifying the clinical benefits of Chukenchuto, this study aims to contribute to the establishment of more appropriate postoperative management strategies.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 12days
Interventions/Control_2 - Take 5 g (a combination of 2.5 g of Daikenchuto extract granules and 2.5 g of Shokenchuto extract granules) three times daily, 30 minutes before each meal.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - Aged 18 years or older
Patients who underwent one of the following surgeries
Laparoscopic surgery: Surgery for benign disease
Robot-assisted surgery: Total hysterectomy or sacrocolpopexy
Patients who provided consent to participate in this study by signing the consent form
Key exclusion criteria - Those who do not meet the following requirements
Aged 18 years or older
Patients who underwent one of the following surgeries:
Laparoscopic surgery: Surgery for benign disease
Robot-assisted surgery: Total hysterectomy or sacrocolpopexy
Patients who provided consent to participate in this study by signing the consent form
Target Size - 330
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 25 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2027 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071000
Disclaimer: Curated by HT Syndication.