Clinical Study on Yiqi Sizi Powder in Promoting Gastrointestinal Function Recovery after Gynecological Abdominal Operatio

Phase 1

• Conditions: Postoperative Gastroinetestinal Dysfuction

• Registration Number: ITMCTR2000003416
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Case source: The observed cases were all hospitalized in the gynecology department of Guangdong Traditional Chinese Medicine Hospital and were selected for laparoscopic surgery.
1. Gynecological laparoscopic patients:
(1) Gynecological laparoscopic surgery.
(2) Age: between 18-70 years old.
(3) Those with 1-4 hours of operation time.
(4) Those who have anesthesia for 1.5-4.5 hours.
(5) TCM syndrome type belongs to qi stagnation and qi deficiency.
(6) Those with informed consent.
2. Healthy people:
(1) Women who have not undergone major surgery.
(2) Age: between 18-70 years old.
(3) No basic diseases, no severe combined diseases such as hypertension, diabetes, cardiovascular, liver, kidney, brain, lung, etc.
(4) Those with informed consent.

Exclusion Criteria

1. Gynecological laparoscopy patients:
1) Malignant tumors require extensive radical resection/enterostomy or those with advanced cachexia and extreme debilitation.
2) Those with combined diseases such as heart, liver, kidney, brain, diabetes, hypertension, etc. who cannot be controlled by treatment and have obvious symptoms.3) Patients with obvious gastrointestinal dysfunction before surgery;
4) Patients with skin disease at the treatment site; those with mental illness, allergy to treatment drugs, pregnant women or lactating women.
5) For patients with moderate or above malnutrition, serum albumin < 27g/L; or prealbumin < 0.14g/L.
6) Those who have abdominal surgery again and severe intestinal adhesions.
7) Those whose intraoperative blood loss exceeds 400 ml, or who need blood transfusion.
8) Those with serious complications within 6 hours after surgery.
9) Those who require intraperitoneal hot perfusion after surgery.
10) Drugs or treatments that have a significant effect on gastrointestinal function must be used after surgery.
11) Patients who are currently participating in or have participated in other clinical trials within 1 month prior to this study.
12) The investigator considers it inappropriate to conduct this clinical research.
2. Healthy people: the researchers believe that this clinical research is not suitable.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal motility evaluation (defecation, exhaust, bowel sounds);