Laparoscopy-assisted SurgeryNCT03470142
The Comparison Between Traditional Laparoscopy-assisted Surgery and NOSES in Radical Resection of Colorectal Cancer
A study testing traditional laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) in people with Laparoscopy-assisted Surgery and Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES), run by Dong Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopy-assisted Surgery, Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
- What is being tested?
- traditional laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2018to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) scale 0-2
- Heart, lung, liver, and kidney function can tolerate operation
- Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Who cannot join
- history of colorectal malignant disease
- recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
- patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
- 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
- combined colorectal multiple carcinomas
- poor anal function before operation and incontinence of defecation
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- with a history of serious mental illness
- pregnant or lactating women
- The researchers believe that the patients are unsuitable to participate in the researchers with other cases. A patient or family refusal to join
Trial locations and contacts
1 site in 1 country.
Dong Yang, Master contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021
Quan Wang, Professor, 18844097668@163.com
About this study
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
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.
- Conditions
- Laparoscopy-assisted Surgery, Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
- Being tested
- traditional laparoscopy-assisted surgery, total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)
- Keywords
- laparoscopy-assisted surgery, NOSES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional laparoscopy-assisted surgeryProcedure or 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.
total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| traditional laparoscopy-assisted surgery | Active comparator | 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. Receives: Procedure: traditional laparoscopy-assisted surgery |
| total laparoscopic surgery with no incision (NOSES) | Experimental | 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. Receives: Procedure: total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of complications
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)
Measured: one month after surgery
Secondary outcomes (8)
the operation time
The descriptive name of unit would be minute (min).
Measured: in the perioperative period
the blood loss during the operation
The descriptive name of unit would be millilitre (ml).
Measured: in the perioperative period
Postoperative recovery of intestinal peristalsis
The descriptive name of unit would be hour (h).
Measured: in the perioperative period
Visual Analogue Scale/Score
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).
Measured: in the perioperative period
the functional outcome of defecation, if there is incontinence
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).
Measured: Three months after operation
3-year disease-free survival
Measured: three years after operation
cases converted to laparotomy
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.
Measured: in the perioperative period
The mean postoperative hospital stay
The descriptive name of unit would be day (d).
Measured: in the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start20 Mar 2018
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopy-assisted SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Yang, Jilin University
- Investigators
- Dong-Hui Sun, Doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470142
- Sponsor's protocol ID
- 130001
- Status last verified
- Sep 2019
- First submitted
- 4 Mar 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03470142
- Acronym / sponsor ID
- 130001
- Conditions
- Laparoscopy-assisted Surgery, Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)
- Keywords
- laparoscopy-assisted surgery, NOSES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Dong YangUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional laparoscopy-assisted surgery | Active comparator | Procedure: traditional laparoscopy-assisted surgeryThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Eastern Cooperative Oncology Group (ECOG) scale 0-2
- Heart, lung, liver, and kidney function can tolerate operation
- Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
Key exclusion criteria (9 listed)
- history of colorectal malignant disease
- recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
- patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
- 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
- combined colorectal multiple carcinomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional laparoscopy-assisted surgeryAll 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. | Procedure or surgery | traditional laparoscopy-assisted surgery |
| 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). | Procedure or surgery | total laparoscopic surgery with no incision (NOSES) |
Primary outcome
the incidence of complications
Time frame: 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)
8 secondary outcomes
the operation time
Time frame: in the perioperative period
the blood loss during the operation
Time frame: in the perioperative period
Postoperative recovery of intestinal peristalsis
Time frame: in the perioperative period
Visual Analogue Scale/Score
Time frame: in the perioperative period
the functional outcome of defecation, if there is incontinence
Time frame: Three months after operation
3-year disease-free survival
Time frame: three years after operation
cases converted to laparotomy
Time frame: in the perioperative period
The mean postoperative hospital stay
Time frame: in the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Yang, Master contact
Dong-Hui Sun, Doctor study director
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) in people with Laparoscopy-assisted Surgery and Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES), run by Dong Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Yang, Master (714488468@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of complications (time frame: one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.