Water Exchange Colonoscopy in Elderly Patients
Water Exchange Colonoscopy in Elderly Patients: A Prospective Randomized Controlled Trial
Colonoscopy is an important test for detecting colorectal polyps and cancer, but it can cause pain and discomfort, especially in older adults. Traditional colonoscopy uses air to expand the colon. Water exchange colonoscopy uses warm water instead of air, which may reduce pain and make the examination easier. This study compared four colonoscopy methods in patients aged 55 years and older: non-anesthesia water injection, non-anesthesia gas insufflation, anesthesia water injection, and anesthesia gas insufflation. Two hundred participants were randomly assigned to one of the four groups. The study measured pain using a visual analog scale, the time needed to reach the cecum, and blood levels of inflammatory markers (IL-1β, IL-6, and PGE2). The results may help doctors choose a safer and more comfortable colonoscopy method for older patients, especially when anesthesia may not be suitable.
調査の概要
状態
詳細な説明
Background: Colorectal cancer incidence and mortality increase with age, and colonoscopy is essential for screening and managing colorectal polyps. Conventional gas insufflation can cause abdominal distension, pain, and loop formation, particularly in elderly patients who often have relaxed abdominal muscles, elongated colons, and comorbidities that increase anesthesia risk. Water exchange colonoscopy has been reported to reduce pain by using warm water to navigate the colon without full gas distension.
Objective: To evaluate the clinical value of non-anesthesia water exchange colonoscopy in elderly patients and compare it with anesthesia water exchange, non-anesthesia gas insufflation, and anesthesia gas insufflation.
Methods: This was a single-center, prospective, randomized controlled trial that enrolled 200 patients aged 55 years or older undergoing colonoscopy between November 2024 and December 2025. Participants were randomly assigned (1:1:1:1) using a random number table to four groups (n=50 each): non-anesthesia water injection (NW), non-anesthesia gas insufflation (NA), anesthesia water injection (AW), and anesthesia gas insufflation (AA). All procedures were performed by an experienced endoscopist using a high-definition colonoscope (Olympus CF-HQ290I). Bowel preparation used standard polyethylene glycol electrolyte powder. In water injection groups, warm water at 37°C was injected through the biopsy channel during insertion, with suction of gas and fluid as needed. In gas insufflation groups, conventional air insufflation was used. Anesthesia groups received intravenous propofol combined with a small amount of opioid, administered by an anesthesiologist with continuous vital sign monitoring. The non-anesthesia groups received no anesthesia or analgesia.
Outcomes: The primary outcomes included maximum pain score during examination measured by a 10-point visual analog scale (VAS), cecal intubation time (minutes from insertion to identification of the ileocecal landmark), and serum levels of inflammatory and pain mediators (IL-1β, IL-6, and PGE2) measured by ELISA before and during colonoscopy. Non-inferiority of AW versus NW was assessed for inflammatory mediator inhibition using pre-specified margins. Statistical analysis used SPSS 25.0, with one-way ANOVA, Tukey HSD test, chi-square test, and non-inferiority testing; P<0.05 was considered statistically significant.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Zhejiang
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Hangzhou、Zhejiang、中国、311300
- Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age ≥ 55 years
- Indications for colonoscopy
- Signed informed consent form
Exclusion Criteria:
- History of intestinal surgery
- Severe intestinal stenosis or obstruction
- Cognitive impairment that precludes cooperation with assessment
研究計画
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：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：Non-anesthesia water injection (NW)
Participants receive water exchange colonoscopy without anesthesia. Warm water at 37°C is injected through the biopsy channel during insertion; gas and fluid are aspirated as needed. No anesthesia or analgesia is administered. |
During endoscope insertion, warm water at 37°C is injected through the biopsy channel to facilitate the procedure. Gas and liquid within the cavity are aspirated as thoroughly as possible. A minimal amount of gas is introduced for observation when necessary.
他の名前：
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実験的：Non-anesthesia gas insufflation (NA)
Participants receive conventional gas insufflation colonoscopy without anesthesia. Air is used to expand the intestinal lumen. No anesthesia or analgesia is administered. |
Conventional air insufflation is employed to expand the intestinal lumen, thereby aiding in endoscope insertion.
他の名前：
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実験的：Anesthesia water injection (AW)
Participants receive water exchange colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. |
During endoscope insertion, warm water at 37°C is injected through the biopsy channel to facilitate the procedure. Gas and liquid within the cavity are aspirated as thoroughly as possible. A minimal amount of gas is introduced for observation when necessary.
他の名前：
Intravenous general anesthesia consisting of propofol combined with a small quantity of opioid drugs, administered by an anesthesiologist prior to the examination, with continuous monitoring of vital signs.
他の名前：
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実験的：Anesthesia gas insufflation (AA)
Participants receive conventional gas insufflation colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. |
Conventional air insufflation is employed to expand the intestinal lumen, thereby aiding in endoscope insertion.
他の名前：
Intravenous general anesthesia consisting of propofol combined with a small quantity of opioid drugs, administered by an anesthesiologist prior to the examination, with continuous monitoring of vital signs.
他の名前：
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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 |
|---|---|---|
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Serum inflammatory factors and pain mediators
時間枠：Baseline and periprocedural
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Change from baseline in serum levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and prostaglandin E2 (PGE2) measured by ELISA before and during colonoscopy. Used for non-inferiority comparison between non-anesthesia water injection (NW) and anesthesia water injection (AW). |
Baseline and periprocedural
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Pain score (VAS)
時間枠：Periprocedural
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Maximum pain level during colonoscopy assessed by the patient using a visual analog scale (VAS, 0-10 points, where 0 indicates no pain and 10 signifies severe pain). |
Periprocedural
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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 |
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Cecal intubation time
時間枠：Periprocedural
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Duration from colonoscope insertion to reaching the ileocecal area and identifying the cecal landmark (e.g., appendiceal orifice or ileocecal valve), recorded in minutes. |
Periprocedural
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Adverse events
時間枠：Periprocedural
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Incidence of procedure-related adverse events, including abdominal distension, pain, intestinal perforation, respiratory depression, cardiovascular events, and allergic reactions. |
Periprocedural
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協力者と研究者
捜査官
- 主任研究者：Yongjian Liao, MD、First People's Hospital of Hangzhou
出版物と役立つリンク
一般刊行物
- He KQ, Huang TT, Tan MY, Gao C, Wang S. Efficacy and Safety of Ciprofol Versus Propofol as Anesthetic for Patients Undergoing Painless Colonoscopy. Pain Ther. 2024 Dec;13(6):1633-1644. doi: 10.1007/s40122-024-00662-x. Epub 2024 Oct 14.
- Xu X, Ni D, Lu Y, Huang X. Diagnostic application of water exchange colonoscopy: A meta-analysis of randomized controlled trials. J Int Med Res. 2019 Feb;47(2):515-527. doi: 10.1177/0300060518819626. Epub 2019 Jan 11.
- Cadoni S, Ishaq S, Hassan C, Falt P, Fuccio L, Siau K, Leung JW, Anderson J, Binmoeller KF, Radaelli F, Rutter MD, Sugimoto S, Muhammad H, Bhandari P, Draganov PV, de Groen P, Wang AY, Yen AW, Hamerski C, Thorlacius H, Neumann H, Ramirez F, Mulder CJJ, Albeniz E, Amato A, Arai M, Bak A, Barret M, Bayupurnama P, Cheung R, Ching HL, Cohen H, Dolwani S, Friedland S, Harada H, Hsieh YH, Hayee B, Kuwai T, Lorenzo-Zuniga V, Liggi M, Mizukami T, Mura D, Nylander D, Olafsson S, Paggi S, Pan Y, Parra-Blanco A, Ransford R, Rodriguez-Sanchez J, Senturk H, Suzuki N, Tseng CW, Uchima H, Uedo N, Leung FW. Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations. Gastrointest Endosc. 2021 Jun;93(6):1411-1420.e18. doi: 10.1016/j.gie.2020.10.011. Epub 2020 Oct 16.
- Ding Y, Lin X. Outcomes and safety of colonoscopy in elderly patients aged 80 years and older: a retrospective cohort study. PeerJ. 2025 Nov 19;13:e20404. doi: 10.7717/peerj.20404. eCollection 2025.
- Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.
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研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
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最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LY2024013K
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