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
| Registry | NCT03470142 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 158 (Estimated) |
| Sponsor | Dong Yang (Other) |
| Conditions | Laparoscopy-assisted Surgery, Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES) |
| Interventions | traditional laparoscopy-assisted surgery, total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) (Procedure) |
| Dates | start 2018-03-20, primary completion 2020-03-20 (estimated), completion 2022-03-20 (estimated), first posted 2018-03-19, last updated 2019-09-24 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Laparoscopy-assisted Surgery All trials for Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES) All trials of traditional laparoscopy-assisted surgery All trials of total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| traditional laparoscopy-assisted surgery | Active comparator | Procedure: traditional laparoscopy-assisted surgery | The traditional laparoscopic operation undergo and then a small incision(5cm) is made in the middle of the lower abdominal wall to trim the mesangial membrane and remove the specimen. At last the anastomosis operation undergo by the laparoscopic operation. |
| total laparoscopic surgery with no incision (NOSES) | Experimental | Procedure: total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) | The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice such as anal. |
Sex: All, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| the First Hospital of Jilin University | Ch’ang-ch’un, Jilin | China | Recruiting |