Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Официальное название

Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

Обзор

This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.

Подробное описание

In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.

Вмешательства

• Процедура Single-incision Laparoscopic Surgery
  In this group，the surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
• Процедура Conventional Laparoscopic Surgery
  In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Первичные конечные точки

• 3-year disease free survival rate [Срок оценки: 36 months after surgery]

Вторичные конечные точки (12)

• Operative time [Срок оценки: intraoperative]
• Intraoperative blood loss [Срок оценки: intraoperative]
• Incision length [Срок оценки: intraoperative]
• Total incision length [Срок оценки: intraoperative]
• Conversion rate [Срок оценки: intraoperative]
• Length of stay [Срок оценки: 1-14 days after surgery]
• Postoperative recovery course [Срок оценки: 1-14 days after surgery]
• Early morbidity rate [Срок оценки: 30 days after surgery]
• Pain score [Срок оценки: 1-3 days after surgery]
• Tumor size [Срок оценки: 14 days after surgery]
• Incisal margin [Срок оценки: 14 days after surgery]
• Lymph node detection [Срок оценки: 14 days after surgery]

Критерии участия

Критерии включения

• 18 years < age ≤85 years
• Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
• Pathological or highly suspected colorectal carcinoma
• Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
• Tumor size of 5 cm or less
• ECOG score is 0-1
• ASA score is Ⅰ-Ⅲ
• Informed consent

Критерии исключения

• Body mass index (BMI) >35 kg/m2
• The lower border of the tumor is located distal to the peritoneal reflection
• Familial adenomatous polyposis (FAP)
• Inflammatory bowel disease (IBD)
• Multiple malignant colorectal tumors
• Pregnant woman or lactating woman
• Severe mental disease
• Previous gastrointestinal surgery (except appendectomy ）
• Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
• Requirement of simultaneous surgery for other disease
• Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 11 центров

• The 940th Hospital of Joint Logistic Support Force of Chinese of PLA — Lanzhou
• Shengjing Hospital — Шэньян
• Liaoning Tumor Hospital & Institute — Шэньян
• Shandong Provincial Hospital — Цзинань
• The General Hospital of Western Theater Command — Чэнду
• Zhejiang Provincial People's Hospital — Ханчжоу
• Shanghai Cancer Center — Шанхай
• Dongfang Hospital Affiliated to Tongji University — Шанхай
• … и ещё 3 центра

Публикации

• Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836. PMID 30303873
• Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882. PMID 32209897
• Song Z, Liu K, Zhang T, Wang B, Shi Y, Jiang Y, Wang C, Chen X, Ji X, Zhao R. Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial. BMC Cancer. 2022 Jul 7;22(1):743. doi: 10.1186/s12885-022-09821-9. PMID 35799145

Идентификаторы

NCT: NCT04527861 · CSILS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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