Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty (OLAX-CRC)
2026年9月10日 更新者：IBRAHIM DOGAN、Van Training and Research Hospital
This prospective randomized pilot study will evaluate whether the use of an oral laxative before elective laparoscopic colorectal surgery affects small-bowel diameter and intraoperative surgical difficulty.
Adult patients scheduled for elective laparoscopic colorectal resection will be randomly assigned to receive either oral laxative plus rectal enema preparation or rectal enema preparation alone.
During surgery, the diameters of the jejunum and ileum will be measured using a standardized method.
The study will also compare operative difficulty, bowel manipulation time, operation duration, need for additional ports, conversion to open surgery, intraoperative complications, blood loss, and early postoperative outcomes between the two groups.
The findings may help clarify whether oral laxative use influences intraoperative conditions during laparoscopic colorectal surgery.
調査の概要
詳細な説明
Mechanical bowel preparation is commonly used before elective colorectal surgery. Although its effects on postoperative outcomes have been widely investigated, limited evidence is available regarding the effect of oral laxatives on intraoperative small-bowel distension and technical difficulty during laparoscopic colorectal surgery. Increased intraluminal fluid following oral laxative administration may lead to small-bowel distension, potentially impairing surgical exposure and increasing the need for bowel manipulation.
In this study, small-bowel diameter will be assessed intraoperatively using a standardized measurement method after laparoscopic access and establishment of pneumoperitoneum. Jejunal diameter will be measured approximately 50 cm distal to the ligament of Treitz, and ileal diameter approximately 20 cm proximal to the ileocecal valve. Measurements will be performed in the transverse plane without applying mesenteric tension and, when feasible, the mean of two measurements will be recorded. At the end of the operation, the operating surgeon will assess overall operative difficulty using a Likert-type scale ranging from very easy to very difficult. This pilot study is intended to provide preliminary evidence for the design of future adequately powered studies and to support the evaluation of current bowel-preparation practices.
研究の種類
介入
入学 (推定)
60
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：İbrahim Doğan
- 電話番号：+905313884966
- メール：dogan_203@hotmail.com
研究場所
-
-
Van
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Van、Van、トルコ（Türkiye）、65300
- 募集
- University of Health Sciences Türkiye, Van Training and Research Hospital
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コンタクト：
- İbrahim Doğan
- 電話番号：+905313884966
- メール：dogan_203@hotmail.com
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective laparoscopic colorectal resection
- American Society of Anesthesiologists (ASA) physical status I-III
- Able and willing to provide written informed consent
Exclusion Criteria:
- Requirement for emergency surgery
- Mechanical intestinal obstruction, gastrointestinal perforation, or generalized peritonitis
- Anticipated extensive intra-abdominal adhesions
- Active inflammatory bowel disease
- Pregnancy
- Serious systemic disease constituting a contraindication to oral laxative use
- Inability to perform standardized intraoperative small-bowel diameter measurements
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Oral Laxative Plus Rectal Enema
Participants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery.
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Participants assigned to the experimental arm will receive an oral laxative as part of preoperative mechanical bowel preparation, in addition to a rectal enema, before elective laparoscopic colorectal surgery.
The oral laxative will be administered according to the institution's standard preoperative bowel preparation protocol.
Participants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery.
Participants in the comparator arm will receive the rectal enema without an oral laxative.
|
|
アクティブコンパレータ：Rectal Enema Alone
Participants assigned to this arm will receive preoperative bowel preparation consisting of a rectal enema alone, without an oral laxative, before elective laparoscopic colorectal surgery.
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Participants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery.
Participants in the comparator arm will receive the rectal enema without an oral laxative.
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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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Intraoperative Jejunal Diameter
時間枠：Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Jejunal diameter will be measured in centimeters approximately 50 cm distal to the ligament of Treitz, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension.
When feasible, two measurements will be obtained and their mean will be recorded.
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Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Intraoperative Ileal Diameter
時間枠：Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Ileal diameter will be measured in centimeters approximately 20 cm proximal to the ileocecal valve, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension.
When feasible, two measurements will be obtained and their mean will be recorded.
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Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Operative Difficulty Score
時間枠：At the end of surgery, on the day of the procedure
|
Overall operative difficulty will be assessed by the operating surgeon at the end of the procedure using a 5-point Likert scale: 1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, and 5 = very difficult.
Higher scores indicate greater operative difficulty.
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At the end of surgery, on the day of the procedure
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Estimated Intraoperative Blood Loss
時間枠：Intraoperatively, on the day of surgery
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The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records.
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Intraoperatively, on the day of surgery
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Incidence of Intraoperative Serosal Injury
時間枠：Intraoperatively, on the day of surgery
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The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record.
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Intraoperatively, on the day of surgery
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Incidence of Intraoperative Organ Injury
時間枠：Intraoperatively, on the day of surgery
|
The number of participants who experience an unintended injury to an intra-abdominal organ during surgery, as documented in the operative record.
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Intraoperatively, on the day of surgery
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Incidence of Intraoperative Bleeding Requiring Intervention
時間枠：Intraoperatively, on the day of surgery
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The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis.
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Intraoperatively, on the day of surgery
|
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Requirement for an Additional Laparoscopic Port
時間枠：Intraoperatively, on the day of surgery
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The number of participants in whom placement of at least one additional laparoscopic port beyond the planned port configuration is required to complete the procedure.
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Intraoperatively, on the day of surgery
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Conversion From Laparoscopic to Open Surgery
時間枠：Intraoperatively, on the day of surgery
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The number of participants whose planned laparoscopic procedure is converted to an open surgical approach.
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Intraoperatively, on the day of surgery
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Incidence of Any Postoperative Complication Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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The number of participants who experience at least one surgery-related postoperative complication within 30 days after surgery.
Each participant will be counted once, regardless of the number of complications experienced.
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From the day of surgery through postoperative day 30
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Incidence of Anastomotic Leakage Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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The number of participants who develop an anastomotic leak within 30 days after surgery, as documented by clinical, radiological, endoscopic, operative, or drainage findings.
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From the day of surgery through postoperative day 30
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Incidence of Surgical Site Infection Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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The number of participants who develop a surgical site infection within 30 days after surgery, including superficial incisional, deep incisional, or organ/space infection.
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From the day of surgery through postoperative day 30
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Incidence of Postoperative Ileus Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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The number of participants who develop postoperative ileus within 30 days after surgery, as documented in the medical record based on delayed recovery or interruption of gastrointestinal function.
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From the day of surgery through postoperative day 30
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Time Required for Bowel Manipulation and Displacement
時間枠：Intraoperatively, on the day of surgery
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The time required to manipulate the bowel and displace it from the operative field during surgery.
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Intraoperatively, on the day of surgery
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Time Required for Intraoperative Bowel Diameter Measurements
時間枠：Intraoperatively, on the day of surgery
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The time required to perform intraoperative measurements of the jejunal and ileal diameters.
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Intraoperatively, on the day of surgery
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Time Required to Complete the Anastomosis
時間枠：Intraoperatively, on the day of surgery
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The time from initiation of anastomosis construction to completion of the anastomosis during surgery.
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Intraoperatively, on the day of surgery
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Total Operation Time
時間枠：Intraoperatively, on the day of surgery
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The total duration of the surgical procedure, defined as the time from skin incision to completion of skin closure.
|
Intraoperatively, on the day of surgery
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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5月22日
一次修了 (推定)
2027年5月22日
研究の完了 (推定)
2027年6月22日
試験登録日
最初に提出
2026年9月5日
QC基準を満たした最初の提出物
2026年9月10日
最初の投稿 (実際)
2026年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月10日
最終確認日
2026年9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。