Clinical trial NCT03470142: The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
Official title: The Comparison Between Traditional Laparoscopy-assisted Surgery and Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery，NOSES) in Radical Resection of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopy-assisted Surgery
Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
Keywords: laparoscopy-assisted surgery
NOSES
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the short-term and long-term outcomes of traditional laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) for colorectal cancer and to find a better surgical method for patients.


Eligibility criteria: Inclusion Criteria:

1. All cases should be diagnosed as rectal or sigmoid colon cancer by histology or cytology. The tumor is 5-20cm from the pectinate line. The clinical stage is T1-2, N0, M0 for rectal cancer and T1-T3, N0-2, M0 for sigmoid colon cancer.
2. Eastern Cooperative Oncology Group (ECOG) scale 0-2
3. Heart, lung, liver, and kidney function can tolerate operation
4. Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.

Exclusion Criteria:

1. history of colorectal malignant disease
2. recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
3. patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
4. a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases
5. combined colorectal multiple carcinomas
6. poor anal function before operation and incontinence of defecation
7. with a history of serious mental illness
8. pregnant or lactating women
9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases. A patient or family refusal to join

Primary outcomes:
measure: the incidence of complications
timeFrame: one month after surgery
Secondary outcomes:
measure: the operation time
timeFrame: in the perioperative period
measure: the blood loss during the operation
timeFrame: in the perioperative period
measure: Postoperative recovery of intestinal peristalsis
timeFrame: in the perioperative period
measure: Visual Analogue Scale/Score
timeFrame: in the perioperative period
measure: the functional outcome of defecation, if there is incontinence
timeFrame: Three months after operation
measure: 3-year disease-free survival
timeFrame: three years after operation
measure: cases converted to laparotomy
timeFrame: in the perioperative period
measure: The mean postoperative hospital stay
timeFrame: in the perioperative period
Other outcomes:
Locations:
city: Ch'ang-ch'un
country: China
facility: the First Hospital of Jilin University
state: JI Lin
Study officials:
affiliation: The First Hospital of Jilin University
name: Dong-Hui Sun, Doctor
role: STUDY_DIRECTOR
References: