Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
2026年8月12日 更新者：Xin Yu、Sir Run Run Shaw Hospital
Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol
The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are:
Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery.
Participants will:
Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days.
Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.
調査の概要
研究の種類
介入
入学 (推定)
190
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xin Yu
- 電話番号：86006663
- メール：xinxin_yu@zju.edu.cn
研究場所
-
-
Shandong
-
Binzhou、Shandong、中国
- まだ募集していません
- Shandong Medical and Pharmaceutical University Hospital
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コンタクト：
- Shuhui Zhang
- 電話番号：18354017338
- メール：3259998310@qq.com
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 募集
- Sir Run Run Shaw Hospital
-
コンタクト：
- Xin Yu
- 電話番号：86006663
- メール：xinxin_yu@zju.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥ 65 years old.
- Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.
- American Society of Anesthesiologists classification (ASA) 1-4.
- Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers.
- The patient voluntarily participates in this study and signs the informed consent form.
Exclusion Criteria:
- Previous history of abdominal gastrointestinal surgery.
- Planned for palliative or emergency surgery.
- Planned for open abdominal surgery or creation of a new stoma.
- Transfer to ICU.
- Diagnosed with severe heart, liver, kidney or mental system diseases.
- Patients with implanted cardiac pacemakers.
- Patients currently using or having used in the past month glucagon-like peptide-1 (GLP-1) receptor agonists, dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.
- Planned to use epidural anesthesia or epidural analgesia.
- Presence of local skin lesions, infection at the stimulation site, or obvious skin allergy or severe skin sensitivity to electrodes/adhesive materials.
- Participated in other clinical studies within the past 3 months or received acupuncture treatment within the past month.
- Other conditions that the investigator considers make the patient unsuitable for participation in this study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：TEA
|
The subjects in the TEA group were placed in the supine position and received transcutaneous electrical acupoint stimulation at the bilateral PC6 and bilateral ST36 .
After confirming the location of the acupoints , special skin treatment was carried out.
The stimulation parameters for PC6 were set as follows: 0.1 seconds of opening stimulation, 0.4 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 100 Hz, and amplitude ranging from 1 to 10 mA (based on the maximum level that the subject could tolerate).
The stimulation parameters for ST36 were set as follows: 2 seconds of opening stimulation, 3 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude ranging from 2 to 10 mA (based on the maximum level that the subject could tolerate).
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偽コンパレータ：sham-TEA
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Sham-TEA was the same except that non-acupoints were used to replace ST36 and PC6.
The sham-acupoint for PC6 was located at about 15-20 cm away from PC6 (up to the elbow and outside of the coastal margin of the forearm not on any meridian) and the sham-point for ST36 was located at 10-15 cm down from and to the lateral side of ST36 not on any meridian
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to First Flatus
時間枠：Assessed up to 10 days after surgery
|
Defined as the period from the end of the surgery to the time of first flatus (hours).
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Assessed up to 10 days after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prolonged post operative ileus (PPOI)
時間枠：Assessed up to 72 hours after surgery
|
defined as no flatus for more than 72 hours
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Assessed up to 72 hours after surgery
|
|
time to first defecation
時間枠：Assessed up to 10 days after surgery
|
Defined as the period from the end of the surgery to the time of first defecation (hours).
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Assessed up to 10 days after surgery
|
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time to first water intake
時間枠：Assessed up to 10 days after surgery
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The time from the end of the surgery to the first water intake (hours)
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Assessed up to 10 days after surgery
|
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Time to tolerance of liquid diet
時間枠：Assessed up to 10 days after surgery
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"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after the liquid diet.
Record the time (in hours) from the end of the surgery to the first tolerance to the liquid diet.
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Assessed up to 10 days after surgery
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Time to tolerance of semi-liquid diet
時間枠：Assessed up to 10 days after surgery
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"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after semi-liquid food.
Record the time ( hours) from the end of the surgery to the first tolerance of semi-liquid food.
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Assessed up to 10 days after surgery
|
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Time to tolerance of solid food
時間枠：Assessed up to 10 days after surgery
|
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after solid food.
Record the time (hours) from the end of the surgery to the first tolerance of solid food.
|
Assessed up to 10 days after surgery
|
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Time to first ambulation
時間枠：Assessed up to 10 days after surgery
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The time from the end of the surgery to the first ambulation (hours).
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Assessed up to 10 days after surgery
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Postoperative nausea
時間枠：At 24, 48, and 72 hours after surgery
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The number and frequency of postoperative nausea episodes
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At 24, 48, and 72 hours after surgery
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postoperative vomiting
時間枠：At 24, 48, and 72 hours after surgery
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The number and frequency of postoperative vomiting
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At 24, 48, and 72 hours after surgery
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postoperative abdominal distension
時間枠：At 24, 48, and 72 hours after surgery
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The number and frequency of postoperative abdominal distension
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At 24, 48, and 72 hours after surgery
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Use of anti-emetic drugs after surgery
時間枠：At 24, 48, and 72 hours after surgery
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Number of participants using antiemetic drugs
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At 24, 48, and 72 hours after surgery
|
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Severity of postoperative pain
時間枠：At 24, 48, and 72 hours after surgery
|
The assessment was conducted using a numerical rating scale (NRS).
The scoring range was 0-10 (0 indicated no pain, while 10 indicated unbearable severe pain.
Scores of 1-3 indicated mild pain that could be tolerated; 4-6 indicated pain that affected sleep but was still tolerable; 7-10 indicated severe pain that affected appetite and sleep).
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At 24, 48, and 72 hours after surgery
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Use of opioids drugs after surgery
時間枠：At 24, 48, and 72 hours after surgery
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The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents.
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At 24, 48, and 72 hours after surgery
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TEA Security
時間枠：Assessed up to 3 days after surgery
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assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)
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Assessed up to 3 days after surgery
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Postoperative complications
時間枠：From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
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The severity of complications was evaluated using the Clavien-Dindo classification system (grades I to V), with Clavien-Dindo grade ≥ III complications serving as the major surgical complications.
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From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
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Total length of hospital stay
時間枠：Assessed up to 30 days after surgery
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primary admission plus any readmission up to 30 days
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Assessed up to 30 days after surgery
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Unplanned readmission
時間枠：Assessed up to 30 days after surgery
|
Record the number of unplanned re-admissions within 30 days of hospital discharge
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Assessed up to 30 days after surgery
|
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Postoperative quality of recovery
時間枠：baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
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Assessed using the Quality of Recovery - 15 score (QoR-15) questionnaire preoperatively and daily.
The total score ranges from 0 to 150 points.
The higher the score, the better the post-anesthesia recovery quality.
|
baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月14日
一次修了 (推定)
2027年4月30日
研究の完了 (推定)
2028年5月31日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月14日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。