Abdominal Acupuncture for Gastrointestinal Function Recovery After Gynecologic Laparoscopic Surgery

NCT07293026 | Completed

• 1 other identifier: YF2023-435
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Current research on the role of abdominal acupuncture in promoting postoperative gastrointestinal recovery remains limited, characterized by a lack of large-scale, standardized clinical trials, particularly with respect to long-term outcomes. This study, grounded in a rigorous randomized controlled trial design, investigates the clinical efficacy of abdominal acupuncture in enhancing gastrointestinal function following gynecologic laparoscopic surgery. The findings aim to provide a scientific foundation for improving postoperative quality of life, optimizing recovery pathways in gynecology, and identifying safer, simpler, and more effective therapeutic options. In addition, this work offers theoretical support and practical evidence to advance the clinical integration and broader application of traditional Chinese therapeutic approaches in modern surgical rehabilitation, underscoring its significant clinical value.

Conditions

Postoperative Ileus; Postoperative Complications; Postoperative Gastrointestinal Dysfunction (POGD)

Keywords

abdominal acupuncture; gastrointestinal function; quality of life; Postoperative Gastrointestinal Dysfunction; Postoperative Ileus; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Time to first postoperative passage of flatus

  Elapsed time from the end of laparoscopic gynecologic surgery to the first documented passage of flatus; patient-reported and nurse-confirmed. Time is recorded in hours and minutes. Per protocol, rescue therapy may be used if no flatus by postoperative Day 3.

  From the end of surgery until the first documented passage of flatus; assessed through postoperative Day 5 or hospital discharge, whichever occurs first.

Secondary Outcomes (7)

• Time to first postoperative bowel movement

  From the end of surgery until the first documented bowel movement; assessed through postoperative Day 5 or hospital discharge, whichever occurs first.

• restoration of bowel sounds

  From the end of surgery until the first detection of normal bowel sounds; assessed every 8 hours through postoperative Day 5 or hospital discharge, whichever occurs first.

• Incidence of postoperative gastrointestinal dysfunction

  From the day of surgery through postoperative Day 5 or hospital discharge, whichever occurs first.

• Inflammatory markers

  Each parameter was assessed once preoperatively, on the day of surgery prior to treatment, and on postoperative Day 5.

• Pain assessment

  Day 0 (day of surgery) and Postoperative Days 1 through 5; or until hospital discharge if earlier.

Other Outcomes (1)

• Adverse Events

  From the day of surgery (Day 0) through Postoperative Day 19 (14 days after the final treatment session), including the treatment period and follow-up.

Study Arms (2)

Abdominal acupuncture treatment group

EXPERIMENTAL

In addition to standard postoperative care, patients received abdominal acupuncture. In the supine position, acupoints were localized proportionally from the umbilicus (CV8): 8 cun upward to CV16, 5 cun downward to the pubic symphysis, and 6 cun laterally. After aseptic skin preparation, disposable sterile needles were inserted perpendicularly. Primary points were needled at the Di level (1.0-1.5 cun) for visceral regulation and secondary points at the Ren level (0.5-1.0 cun) for peripheral stimulation. Gentle rotation was applied without lifting or thrusting, and deqi was not required. Needles were retained for 30 minutes with concurrent infrared warming. After withdrawal, sterile compression prevented bleeding. The first session was administered 4-6 hours postoperatively, followed by one daily on postoperative days 1-4, totaling five sessions. Clinical status was documented throughout.

Procedure: Abdominal acupuncture; Other: Standard postoperative management protocol

control group

ACTIVE COMPARATOR

The standardized postoperative management protocol consists of the following components: 1. Early oral intake: patients may commence a liquid diet 6 hours after surgery, advance to a semi-liquid diet following the passage of flatus, and transition to a regular diet after bowel movement. 2. Early mobilization: patients are encouraged to turn in bed and initiate physical activity as early as 6 hours postoperatively, and to ambulate as soon as their condition permits. 3. Adequate fluid supplementation. 4. Maintenance of fluid-electrolyte and acid-base balance. 5. Prophylactic antibiotic therapy to prevent infection. 6. Early removal of urinary catheters, drainage tubes, and other indwelling devices. 7. Postoperative analgesia: implementation of a multimodal pain management strategy. 8. In critically ill patients, supplemental oxygen and continuous electrocardiographic monitoring are required.

Other: Standard postoperative management protocol

Interventions

Abdominal acupuncture PROCEDURE

Patients were positioned supine with the abdomen exposed. Acupoint selection and localization followed Abdominal Acupuncture Therapy standards, with proportional measurements taken from the umbilicus (CV8): 8 cun upward to CV16, 5 cun downward to the pubic symphysis, and 6 cun laterally. After hand hygiene and aseptic skin preparation, disposable sterile needles were inserted perpendicularly. Primary acupoints were needled at the Di level (1.0-1.5 cun) targeting visceral disorders, and secondary acupoints at the Ren level (0.5-1.0 cun) for peripheral regulation. Gentle rotation was employed without lifting/thrusting, and deqi induction was not required. Needles were retained for 30 minutes with concurrent infrared warming therapy. Post-treatment, needles were withdrawn with sterile compression applied to prevent bleeding. The first session was given 4-6 hours postoperatively, followed by one session daily on postoperative days 1-4, for a total of five sessions.

Also known as: acupuncture, Abdominal acupuncture treatment, Bo's Abdominal Acupuncture

Abdominal acupuncture treatment group

Standard postoperative management protocol OTHER

Multimodal perioperative care including early oral intake, early mobilization, fluid and electrolyte balance, prophylactic antibiotics, device removal, multimodal analgesia, and supportive monitoring; gastrointestinal prokinetics, enemas, and herbal medicines prohibited.

Abdominal acupuncture treatment group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients who underwent gynecologic laparoscopic total hysterectomy under general anesthesia;
• Age between 18 and 65 years;
• Surgical duration ranging from 0.5 to 4.5 hours;
• Anesthesia duration ranging from 1 to 5 hours;
• Willingness to receive acupuncture therapy without a history of adverse reactions such as needle syncope;
• Provision of signed informed consent.

You may not qualify if:

• Patients with comorbid conditions that may affect gastrointestinal function, including intestinal obstruction or space-occupying lesions of the digestive system;
• Patients with severe systemic diseases, including hepatic or renal failure, cardiovascular or cerebrovascular disorders, infectious diseases such as HIV/AIDS, or severe psychiatric illness;
• Individuals with a history of adverse reactions to acupuncture, including needle syncope;
• Patients with local skin damage, rashes, or ulcers at the proposed acupoint sites;
• Patients concurrently enrolled in other clinical studies.

Sponsors & Collaborators

• Mengyao Han: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• YI Chen, Ph.D

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: December 18, 2025
• Study Start: December 21, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: It is not yet determined. The relevant content can be shared after the paper is published.

Locations

CN (1)