Abdominal Acupuncture for Gastrointestinal Function Recovery After Gynecologic Laparoscopic Surgery

NCT ID: NCT07293026

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-21
• Study Completion Date: 2025-01-20

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.

Detailed Description

This single-center, randomized, parallel-group clinical trial evaluates the adjunctive use of Bo's abdominal acupuncture in women undergoing laparoscopic total hysterectomy at Guangdong Provincial Hospital of Chinese Medicine. The trial is designed to test whether adding abdominal acupuncture to standardized postoperative care can enhance gastrointestinal recovery and is safe in this setting. The protocol was approved by the institutional ethics committee. Eligible participants are randomized 1:1 using an independently generated, concealed allocation sequence (sequentially numbered, opaque, sealed envelopes). Because of the nature of the intervention, treating acupuncturists are not blinded, while outcome assessors and data analysts remain blinded to group assignment.

All participants receive standardized postoperative care per institutional pathways, and therapies that directly affect gastrointestinal motility are restricted unless prespecified rescue criteria are met. Participants assigned to the intervention arm receive Bo's abdominal acupuncture beginning 4-6 hours after surgery and once daily on postoperative days 1-4 (five sessions in total). Treatment follows a standardized technique grounded in pattern differentiation, delivered with sterile single-use needles and approximately 30 minutes of needle retention; full procedural details are provided in the Interventions section of this record. Outcomes, instruments, and time frames are prespecified in the Outcome Measures module; the primary endpoint is time to first passage of flatus, and secondary measures encompass gastrointestinal recovery, adverse events and postoperative complications, inflammatory biomarkers, pain, and gastrointestinal quality of life. Safety is monitored throughout with reporting per institutional policy. Statistical analyses will follow an intention-to-treat approach where feasible, using appropriate parametric or nonparametric tests for continuous variables, chi-square or Fisher exact tests for categorical variables, and repeated-measures models for longitudinal data, with two-sided α=0.05 and effect estimates reported with 95% confidence intervals.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Abdominal acupuncture treatment group

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.

Group Type: EXPERIMENTAL

Abdominal acupuncture

Intervention Type: 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.

Standard postoperative management protocol

Intervention Type: 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.

control group

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.

Group Type: ACTIVE_COMPARATOR

Standard postoperative management protocol

Intervention Type: 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.

Interventions

Abdominal acupuncture

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.

Intervention Type: PROCEDURE

Standard postoperative management protocol

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.

Intervention Type: OTHER

Other Intervention Names

acupuncture; Abdominal acupuncture treatment; Bo's Abdominal Acupuncture

Eligibility Criteria

Inclusion Criteria

1. Female patients who underwent gynecologic laparoscopic total hysterectomy under general anesthesia;

2. Age between 18 and 65 years;

3. Surgical duration ranging from 0.5 to 4.5 hours;

4. Anesthesia duration ranging from 1 to 5 hours;

5. Willingness to receive acupuncture therapy without a history of adverse reactions such as needle syncope;

6. Provision of signed informed consent.

Exclusion Criteria

1. Patients with comorbid conditions that may affect gastrointestinal function, including intestinal obstruction or space-occupying lesions of the digestive system;

2. Patients with severe systemic diseases, including hepatic or renal failure, cardiovascular or cerebrovascular disorders, infectious diseases such as HIV/AIDS, or severe psychiatric illness;

3. Individuals with a history of adverse reactions to acupuncture, including needle syncope;

4. Patients with local skin damage, rashes, or ulcers at the proposed acupoint sites;

5. Patients concurrently enrolled in other clinical studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mengyao Han

OTHER

Sponsor Role: lead

Responsible Party

Mengyao Han

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

YI Chen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

YF2023-435

Identifier Type: -

Identifier Source: org_study_id