The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer

Not Applicable

• Conditions: Laparoscopy-assisted Surgery; Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
• Interventions: Procedure: total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES); Procedure: traditional laparoscopy-assisted surgery

• Registration Number: NCT03470142
• Lead Sponsor: Dong Yang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-04
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2018-03-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24
• Primary Completion: 2020-03-20
• Study Completion: 2022-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total laparoscopic surgery with no incision (NOSES)	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.
traditional laparoscopy-assisted surgery	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.

Primary Outcome Measures

Name	Time	Method
the incidence of complications	one month after surgery	All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.The classification mainly focuses on the medical perspective, with major emphasis on the risk and invasiveness of the therapy used to correct a complication. From light to heavy, it consists of five grades (Ⅰ to Ⅴ)

Secondary Outcome Measures

Name	Time	Method
the operation time	in the perioperative period	The descriptive name of unit would be minute (min).
the blood loss during the operation	in the perioperative period	The descriptive name of unit would be millilitre (ml).
Postoperative recovery of intestinal peristalsis	in the perioperative period	The descriptive name of unit would be hour (h).
Visual Analogue Scale/Score	in the perioperative period	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).
the functional outcome of defecation, if there is incontinence	Three months after operation	Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle).
3-year disease-free survival	three years after operation
The mean postoperative hospital stay	in the perioperative period	The descriptive name of unit would be day (d).
cases converted to laparotomy	in the perioperative period	The procedure for cases who underwent laparoscopy-assisted surgery or NOSES can not go successfully, and then it will be converted to laparotomy. The number of all those cases should be recorded.

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Ch'ang-ch'un, JI Lin, China