Clinical trial NCT04201717: Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer
Official title: A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: total laparoscopic
laparoscopic assisted
intracorporeal anastomosis
extracorporeal anastomosis
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 350
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: This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.

Detailed description: This is a prospective, randomized controlled trial. In this trial, cases in the intracorporeal anastomosis group and the extracorporeal anastomosis group are allocated at a 1:1 ratio among patients undergoing laparoscopic radical left hemicolectomy. The peri-operative recovery data, complications, oncology outcomes, and survival are compared.

Eligibility criteria: Inclusion criteria

1. age between 18 and 80 years;
2. histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
3. clinical stage T1-4a, N0-2, and M0;
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
5. suitable for laparoscopic colectomy;
6. no previous systemic chemotherapy or radiotherapy;
7. willing to provide written informed consent and comply with the research procedures.

Exclusion criteria

1. Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
3. Patients who need to undergo combined organ resection or robot-assisted colectomy.
4. Patients who are receiving preoperative neoadjuvant therapy.
5. ASA grade ≥ IV and/or ECOG performance status score \> 2.
6. Cardiopulmonary dysfunction (NYHA cardiac function classification II-IV), liver dysfunction (MELD score greater than 12), or kidney dysfunction (serum creatinine above the upper limit of normal);
7. Patients with severe psychiatric illness.
8. Pregnant or lactating women.
9. Patients who have a history of taking hormonal drugs.
10. Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
11. Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.

Exit criteria

1. Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
2. Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
3. Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
4. Patients who need combined organ resection as determined by intraoperative exploration.
5. Patients who request to withdraw from this study cohort for various reasons after being enrolled in the study, or who cannot complete the study plan and follow-up for various reasons.

Primary outcomes:
measure: The Count of Participants With Surgical Site Infection (SSI)
timeFrame: one month after surgery
Secondary outcomes:
measure: the Blood Loss
timeFrame: one hour after surgery
measure: the Operating Time
timeFrame: one hour after surgery
measure: the Incidence of Complications
timeFrame: one month after surgery
measure: The Rate of Conversion to Open Surgery
timeFrame: one hour after surgery
measure: Completeness of Specimens
timeFrame: one hour after surgery
measure: Number of Lymph Nodes Dissected
timeFrame: one week after surgery
measure: First Defecation Time
timeFrame: one week after surgery
measure: the Incision Length
timeFrame: one hour after surgery
measure: Visual Analogue Scale/Score (VAS)
timeFrame: 2 days after surgery
measure: 3-year DFS (Disease-free Survival)
timeFrame: three years after the operation
measure: 5-year OS (Overall Survival)
timeFrame: five years after the operation
measure: First Time for Fluid Diet
timeFrame: one week after surgery
measure: Postoperative Hospital Stay
timeFrame: one month after surgery
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Ji Lin
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Chang chun
country: China
facility: The Third Hospital of Jilin University (China - Japan Union Hospital of Jilin University)
city: Chongqing
country: China
facility: Daping Hospital of Army Medical University
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center (Cancer Hospital Affiliated to Fudan University)
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: