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Colorectal CancerPhase 2NCT04268290

Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer

A Phase 2 study testing Single incision plus one port laparoscopic surgery in people with Colorectal Cancer, run by Nanfang Hospital, Southern Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Single incision plus one port laparoscopic surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
15 Feb 2020to 15 Feb 2022
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary tumor diagnosed as adenocarcinoma confirmed pathologically by endoscopic biopsy
  • cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
  • Located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, the upper segment of the rectum.
  • Diameter ≦ 5cm
  • No severe organ dysfunction
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) score class I or II
  • Written informed consent

Who cannot join

  • Unsuitable for patients undergoing single incision plus one port laparoscopic surgery
  • Patients with Complications caused by colorectal cancer ( bleeding , perforation, obstruction or incomplete obstruction )
  • Previous abdominal surgery
  • Malignant diseases within the past 5years
  • Requirements of simultaneous surgery for another diseases

Trial locations and contacts

No sites are listed yet.

Wang Yanan, M.D contact

+86-131-8909-6629

wyn8116@163.com

About this study

Official title: Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial

Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. To achieve further minimally invasive outcomes, SILS plus one port surgery was attempted by some surgeons. Preliminary results showed that SILS+1 could achieve better minimally invasive benefits than CLS while preserving oncologic feasibility.

Till now, ERAS has been practiced in colorectal cancer surgery for approximately 20 years. Studies have proven that ERAS is safe and significantly improved the recovery course of patients during perioperative period, meanwhile, the expense could be greatly reduced.

Based on ERAS studies protocols and SILS+1 trials, investigators tried to combine SILS+1 with ERAS, hopefully to provide patients with more safe, economic, feasible and rapid surgery and perioperative strategies.

Being tested
Single incision plus one port laparoscopic surgery
Keywords
Colorectal Cancer, ERAS, Single Incision plus one, Laparoscopic surgery
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single incision plus one port laparoscopic surgeryCombination product

    Also called The program of enhanced recovery After Surgery

    SILS plus one port surgery and enhanced recovery after surgery protocol both are methods taking the minimally invasive benefits for the patients including faster recovery, reduced postoperative pain and shorter hospital stay.

Study groups in NCT04268290
Study groupRoleWhat they receive
SILS plus one assistant ERASExperimentalPreoperative: preadmission information, education, counseling, optimization ( breathing training), shortening fasting time and carbohydrate load Intraoperative: The intravenous fluid therapy is restricted. All patients undergo single incision plus one port laparoscopic surgery(SILS plus one). A suitable warming device (such as forced-air heating blankets) and warmed intravenous fluids are been adopted routinely to keep body temperature Postoperative: multimodal analgesia (surgical site infiltration, a nonsteroidal anti-inflammatory drug, epidural analgesia) early oral intake and move. nasogastric tubes should not be used routinely. Nasogastric tubes inserted during surgery are been removed before reversal of an aesthesia.
Receives: Combination Product: Single incision plus one port laparoscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rehabilitative rate

    The percentage of patients who met discharge criteria in the fourth day after surgery

    Measured: 4 days

  2. Postoperative hospital stays

    Days from surgery to discharge

    Measured: 1 month

Secondary outcomes (8)

  1. Medical cost

    The patient's expenses from surgery to discharge are recorded in RMB "yuan"

    Measured: 1 month

  2. Postoperative pain score

    Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day . On a scale of 1 to 10, the higher the score, the greater the pain.

    Measured: Once a day from 6 hours to the fourth day after surgery

  3. Postoperative recovery index

    The first Time to early mobilization(hour), flatus(hour), liquid diet(hour), soft diet(hour), removal of the Nasogastric tubes(hour) , removal of the peritoneal drainage(hour) are used to assess the postoperative recovery

    Measured: 1 month

  4. Postoperative inflammatory immune response

    It includes the number of white blood cells and lymphocytes,CRP, IL-6

    Measured: 3 days

  5. compliance with ERAS measures

    It is defined as if the patients complete every ERAS measure or not. We can defined it "yes " or "not".

    Measured: perioperative

  6. 6 min postoperative walking test(6MWT)

    Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002.

    Measured: Once a day from the frist to the fourth day after surgery

  7. hospital readmissions

    It can be defined as the number of patients readmitted within 30 days because of postoperative complications.

    Measured: 30days

  8. Morbidity and mortality rates

    Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start15 Feb 2020 (estimated)
  3. Primary completion15 Feb 2022 (estimated)
  4. Study completion15 Feb 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268290
Sponsor's protocol ID
NFEC-2019-156
Status last verified
Nov 2019
First submitted
25 Dec 2019
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang X, Li G, Li X, Liang Z, Lan X, Mou T, Xu Z, Fu J, Wu M, Li G, Wang Y. Effect of single-incision plus one port laparoscopic surgery assisted with enhanced recovery after surgery on colorectal cancer: study protocol for a single-arm trial. Transl Cancer Res. 2021 Dec;10(12):5443-5453. doi: 10.21037/tcr-21-1361.

    PubMed 35116390

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Single incision plus one port laparoscopic surgery in people with Colorectal Cancer, run by Nanfang Hospital, Southern Medical University.

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 8 inclusion and 5 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Wang Yanan, M.D (+86-131-8909-6629, wyn8116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rehabilitative rate (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04268290, which also lists 1 linked publication.

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 13 Feb 2020.

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