Clinical trial NCT03151733: Single Incision Laparoscopic Colorectal Surgery
Official title: Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Colorectal Surgery
Keywords: SILS
colorectal cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

Detailed description: The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Eligibility criteria: Inclusion Criteria:

* 18 years \< age \< 80 years
* Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
* Pathological colorectal carcinoma
* Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th 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

Exclusion Criteria:

* Body mass index (BMI) \>30 kg/m2
* The lower border of the tumor is located distal to the peritoneal reflection
* Pregnant woman or lactating woman
* Severe mental disease
* Previous abdominal surgery（except appendectomy and cholecystotomy）
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
* Requirement of simultaneous surgery for other disease

Primary outcomes:
measure: Early morbidity rate
timeFrame: 30 days
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Incision length
timeFrame: intraoperative
measure: Lymph node detection
timeFrame: 14 days after surgery
measure: Incisal margin
timeFrame: 14 days after surgery
measure: Tumor size
timeFrame: 14 days after surgery
measure: Length of stay
timeFrame: 1-14 days after surgery
measure: Postoperative recovery course
timeFrame: 1-14 days after surgery
measure: Pain score
timeFrame: 1-3 days after surgery
measure: 3-year disease free survival rate
timeFrame: 36 months after surgery
measure: 5-year overall survival rate
timeFrame: 60 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ruijin hospital North
state: Shanghai
Study officials:
affiliation: ruijin hospitla North
name: Liu Kun, MD
role: STUDY_CHAIR
References:
citation: Aldeghaither S, Zubaidi A, Alkhayal K, Al-Obaid O. Single-incision laparoscopic colorectal surgery: a report of 33 cases in Saudi Arabia. Ann Saudi Med. 2016 Jul-Aug;36(4):282-7. doi: 10.5144/0256-4947.2016.282.
citation: Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.
citation: Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.