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

NCT ID: NCT03470142

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2022-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopy-assisted Surgery Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

traditional laparoscopy-assisted surgery

Intervention Type PROCEDURE

All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. 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)

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.

Group Type EXPERIMENTAL

total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)

Intervention Type PROCEDURE

All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice (anal).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

traditional laparoscopy-assisted surgery

All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. 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.

Intervention Type PROCEDURE

total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)

All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice (anal).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dong Yang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dong Yang

doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dong-Hui Sun, Doctor

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dong Yang, Master

Role: CONTACT

Quan Wang, Doctor

Role: CONTACT

043181875602

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Quan Wang, Professor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

130001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.