Clinical study for Xiangbin prescription for promoting recovery of gastrointestinal function after gynecological surgery

Phase 2

Completed

• Conditions: Perioperative Gastrointestinal Dysfunction of Gynecological Surgery

• Registration Number: ITMCTR1900002637
• Lead Sponsor: The Second Clinical Medical College of Guangzhou University of Traditional 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: Completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Undergone gynecological laparoscopic surgery;
2. Aged between 18 and 65 years old;
3. Operation duration 0.5–4.5 h;
4. Anesthesia duration 1.0–5.0 h;
5. TCM syndrome Qi deficiency, Qi stagnation, blood stasis and bowel-qi?obstruction;
6. Provided informed consent.

Exclusion Criteria

1. Advanced malignant tumor cachexia or extreme weakness;
2. Malignant tumors requiring extended radical surgery;
3. Serious cardiovascular, liver, kidney, brain, lung co-morbidity and other combined diseases;
4. Mental illness;
5. Hypertension or diabetes poorly controlled by drugs;
6. Allergic to the intervention;
7. Pregnant or breast-feeding women;
8. Severe malnutrition defined as serum albumin < 21g/L; pre-albumin < 0.10g/L;
9. Hypertension or diabetes poorly controlled by drugs;
10. Need for second abdominal surgery with severe intestinal adhesion;
11. Serious complications occurring within 6 hours after surgery(e.g., multiple organ dysfunction);
12. Postoperative intraperitoneal hyperthermic perfusion;
13. Have undergone emergency surgery;
14. Need for other gastroprokinetic drugs after surgery;
15. Current participation in or past participation in other clinical trials within one month prior to this study;
16. Considered inappropriate to participate in this study by the clinical investigators;
17. Need for blood transfusion; blood loss during surgery > 400 mL.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
first defecation time after surgery;first flatus time after surgery;the bowel sound recovery time after surgery;