Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis

Официальное название

The Role of Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Totally Intracorporeal Anastomosis for Colon Cancer: A Randomized Controlled Trial

Обзор

This study is a randomized controlled trial conducted at University Medical Center Ho Chi Minh City to evaluate the role of mechanical bowel preparation (MBP) in patients undergoing laparoscopic right hemicolectomy with totally intracorporeal anastomosis for colon cancer. Mechanical bowel preparation is commonly used before colorectal surgery to reduce bowel contents and potentially decrease the risk of postoperative infections. However, its benefit remains controversial, particularly in intracorporeal anastomosis, where intra-abdominal contamination may influence surgical outcomes. In this study, eligible patients will be randomly assigned to one of two groups: with or without mechanical bowel preparation before surgery. The study aims to compare intraoperative events, postoperative complications, and recovery outcomes between the two groups. The primary outcome is the rate of surgical site infection (SSI) within 30 days after surgery. Secondary outcomes include intraoperative fecal contamination, anastomotic leakage, postoperative ileus, operative time, and recovery parameters such as time to first bowel movement and length of hospital stay. The findings of this study are expected to clarify the role of mechanical bowel preparation in reducing postoperative infections and improving surgical outcomes in patients undergoing laparoscopic right hemicolectomy.

Подробное описание

This randomized controlled trial evaluates the role of mechanical bowel preparation (MBP) in patients undergoing laparoscopic right hemicolectomy with totally intracorporeal anastomosis for colon cancer. Participants are randomly assigned to receive MBP or no MBP prior to surgery using a web-based minimization algorithm. The primary endpoint is surgical site infection within 30 days. Secondary outcomes include intraoperative contamination, anastomotic leakage, postoperative ileus, operative time, and recovery parameters. The study aims to determine whether MBP improves surgical outcomes in this setting.

Вмешательства

• Другое Mechanical Bowel Preparation
  Mechanical bowel preparation is administered prior to surgery using standard bowel-cleansing agents according to institutional practice.
• Другое No mechanical bowel preparation
  No mechanical bowel preparation is administered prior to surgery. Patients proceed directly to surgery following standard preoperative care.

Первичные конечные точки

• Surgical Site Infection (SSI) [Срок оценки: Within 30 days after surgery]

Вторичные конечные точки (4)

• Intraoperative Fecal Contamination [Срок оценки: During surgery]
• Anastomotic Leakage [Срок оценки: Within 30 days after surgery]
• Postoperative Ileus [Срок оценки: Within 30 days after surgery]
• Operative Time [Срок оценки: During surgery]

Критерии участия

Критерии включения

• Patients with colon cancer stage I-III according to the TNM classification
• Patients undergoing elective right hemicolectomy or extended right hemicolectomy with totally intracorporeal anastomosis at University Medical Center Ho Chi Minh City
• Postoperative histopathological confirmation of adenocarcinoma

Критерии исключения

• Patients undergoing emergency surgery
• Contraindications to mechanical bowel preparation (e.g., bowel obstruction, subobstruction, bowel perforation, or peritumoral abscess)
• Contraindications to laparoscopic surgery (American Society of Anesthesiologists \[ASA\] physical status IV or V) or to intracorporeal anastomosis
• Distant metastasis at the time of surgery (stage IV according to the TNM classification)
• Recurrent colon cancer after prior surgery
• Synchronous primary malignancies in other organs
• Patients undergoing palliative surgery or surgery for tumor-related complications (non-curative intent)
• Inability to complete follow-up or be contacted

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• University Medical Center HCMC — Ho Chi Minh City

Идентификаторы

NCT: NCT07546565 · 442/2025/HĐ-ĐHYD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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