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Postoperative ComplicationsNCT07293026

Abdominal Acupuncture for Gastrointestinal Function Recovery After Gynecologic Laparoscopic Surgery

A study testing Abdominal acupuncture and Standard postoperative management protocol in people with Postoperative Complications and Postoperative Gastrointestinal Dysfunction (POGD), run by Mengyao Han at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Abdominal acupuncture and Standard postoperative management protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
21 Dec 2023to 20 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: Clinical Study on the Efficacy of Abdominal Acupuncture in Promoting Gastrointestinal Function Recovery After Gynecological Laparoscopic Surgery

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.

Read the 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.

Being tested
Abdominal acupuncture, Standard postoperative management protocol
Keywords
abdominal acupuncture, gastrointestinal function, quality of life, Postoperative Gastrointestinal Dysfunction, Postoperative Ileus, Postoperative Complications
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal acupunctureProcedure or surgery

    Also called acupuncture, Abdominal acupuncture treatment, Bo's 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.

  • Standard postoperative management protocolOther

    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.

Study groups in NCT07293026
Study groupRoleWhat they receive
Abdominal acupuncture treatment groupExperimentalIn 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.
Receives: Procedure: Abdominal acupuncture; Other: Standard postoperative management protocol
control groupActive comparatorThe 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.
Receives: Other: Standard postoperative management protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Time to first postoperative bowel movement

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

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

  2. restoration of bowel sounds

    Elapsed time from the end of surgery to the first auscultated normal bowel sounds (defined as 4 or more sounds per minute in all four quadrants). Auscultation is performed every 8 hours until recovery.

    Measured: 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.

  3. Incidence of postoperative gastrointestinal dysfunction

    Proportion of participants with gastrointestinal dysfunction-related complications (abdominal bloating/pain, nausea, vomiting, diarrhea, or postoperative ileus). Events are confirmed by a physician or nursing staff.

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

  4. Inflammatory markers

    Inflammatory markers included C-reactive protein (CRP), serum interleukin-6 (IL-6), serum tumor necrosis factor-α (TNF-α), and the systemic immune-inflammation index [SII, SII = (platelet count × neutrophil count) / lymphocyte count].

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

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

  5. Pain assessment

    Abdominal pain intensity will be assessed using the Visual Analog Scale for Pain (VAS), a 10-centimeter horizontal line anchored at 0 = no pain and 10 = worst imaginable pain. Scores range from 0 to 10; higher scores indicate worse pain. Assessments will be performed twice on the day of surgery (before and after the first acupuncture session) and once daily on Postoperative Days 1 through 5.

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

  6. Gastrointestinal Symptom Score

    Adapted from the Perioperative Clinical Evaluation Standards for Gastrointestinal Motility (Guangdong Provincial Standard). Composite of nine items: flatus (present=15; absent=0), defecation (present=15; absent=0), abdominal distension/pain (none=10; mild=5; intolerable=0), bowel sounds (normal=10; reduced=5; absent=0), nausea (none=10; mild with activity only=5; intermittent or persistent at rest=0), vomiting (none=10; 1-2/day=5; ≥3/day=0), diarrhea (none=10; 1-2/day=5; ≥3/day=0), surgical incision (well-approximated without redness/swelling/pain=10; any of these, fat liquefaction, or dehiscence=0), and body temperature (≤37.5°C=10; 37.5-<39.0°C=5; ≥39.0°C=0). Total score 0-100; higher scores indicate better gastrointestinal function. Normal bowel sounds are defined as ≥4 sounds/min in all quadrants. Episode counts refer to the prior 24 hours for vomiting/diarrhea. Assessments are performed by trained staff and recorded in case report forms.

    Measured: Day 0 (day of surgery; pre-intervention assessment) and Postoperative Days 1 through 5; assessed once daily or until hospital discharge if earlier.

  7. Gastrointestinal quality of life assessment

    Health-related quality of life will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire covering gastrointestinal symptoms, physical function, emotional status, social function, and the effect of treatment. Each item is scored 0-4, yielding a total score of 0-144 points; higher scores indicate better health-related quality of life. The recall period is the past week (one-week recall); the items and scoring follow the original instrument.

    Measured: Day 0 (day of surgery; pre-intervention baseline), Postoperative Day 5 (or at hospital discharge if earlier), and approximately Postoperative Day 19 (14 days after the final treatment; allowable window ±2 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start21 Dec 2023
  3. Primary completion20 Dec 2024
  4. Study completion20 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293026
Sponsor's protocol ID
YF2023-435
Status last verified
Dec 2025
First submitted
2 Oct 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Can be shared after research paper is published

Questions about this trial

What is this clinical trial studying?

A study testing Abdominal acupuncture and Standard postoperative management protocol in people with Postoperative Complications and Postoperative Gastrointestinal Dysfunction (POGD), run by Mengyao Han at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first postoperative passage of flatus (time frame: From the end of surgery until the first documented passage of flatus; assessed through postoperative Day 5 or hospital discharge, whichever occurs first.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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