Clinical trial NCT03633539: Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Official title: Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Colonic Neoplasms
Rectal Neoplasms
Colon Disease
Colon Cancer
Rectal Cancer
Rectal Diseases
Keywords: SILS
colorectal cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Fudan University
name: RenJi Hospital
First posted: 2018-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* 18 years \< age ≤85 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 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

Exclusion Criteria:

* Body mass index (BMI) \>35 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: Postoperative complications
timeFrame: 30 days after surgery
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
Study officials:
affiliation: Ruijin Hospitla North
name: Kun Liu, MD
role: STUDY_CHAIR
References:
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.