Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis

Обзор

Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. The removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. If gallbladder perforation is not treated in time, the mortality rate is 30 %. Acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. At present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. Their postoperative quality of life, pain and scar-related complications, remain major factors for patients.In recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. At present, there are few reports on randomized controlled clinical trials of SILC in patients with acute cholecystitis, and there is a lack of large sample size studies.Due to the difficulty of SILC operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of SILC in acute cholecystitis surgery. Based on the current status, the purpose of this study was to investigate the effect of SILC on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.

Вмешательства

• Процедура Open cholecystectomy
  The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

Первичные конечные точки

• Quality of life (time to return to normal life) [Срок оценки: 3 years]

Вторичные конечные точки (1)

• Cosmetic result [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Acute cholecystitis（GradeⅠ，II）

Критерии исключения

• Combined with liver cirrhosis (Child grade B and above)
• Upper abdominal surgical history;
• Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.)
• Patients and their families do not agree with the treatment lost follow-up

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Huangshan City
• 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Ханчжоу
• Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Huzhou
• Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Lishui
• Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University — Meicheng

Идентификаторы

NCT: NCT06074679 · 2023-0690

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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