NCT05879172

Brief Summary

Compared with traditional manual suturing, mechanical anastomosis can reduce the error caused by human factors. The electric anastomotic device can improve the automation and accuracy of anastomosis, reduce the requirements for doctors' operation, and establish a more standardized usage specification, thereby reducing the surgical complication rate and improving the quality of anastomosis. The clinical study of electric tubular anastomotic device adopts a multicenter, randomized, parallel controlled non-inferior study design, and randomly groups according to the 1:1 ratio to evaluate the clinical effectiveness and safety of electric tubular anastomotic device compared with conventional manual device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

May 7, 2023

Last Update Submit

May 18, 2023

Conditions

AnastomosisRectal Cancer

Keywords

electric tubular anastomotic device

Outcome Measures

Primary Outcomes (1)

  • success rate of anastomosis

    The end-to-end and end-to-side anastomosis of the intestinal tissue is performed during the operation. After the performance of anastomosis, the instrument is withdrawn. The anastomosis should be checked of accuracy, completeness and bleeding.

    1 week after surgery

Secondary Outcomes (2)

  • time period of anastomosis

    during the operation

  • time period of recovery

    1 year after surgey

Study Arms (2)

traditional anastomotic device

ACTIVE COMPARATOR
Device: traditional anastomotic device

electric tubular anastomotic device

EXPERIMENTAL
Device: electric tubular anastomotic device

Interventions

electric tubular anastomotic deviceDEVICE

The electric tubular anastomotic device developed by Suzhou Yingtukang Medical Technology Co., Ltd. is used for colorectal end-to-end and end-to-side anastomosis. This product is suitable for open or minimally invasive colorectal cancer surgery. Before firing the device, tissue thickness should be carefully assessed to prevent poor staling leading to leakage, inadequate hemostasis, or poor treatment.

electric tubular anastomotic device
traditional anastomotic deviceDEVICE

Traditional anastomosis is used in this group. Staplers of the same brand are uniformly adopted to avoid differences between groups caused by different brands.

traditional anastomotic device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-80y;
  • Patients with resectable rectal cancer who are scheduled to undergo Dixon surgery (definition of rectal cancer: the lower boundary of the tumor is 10 cm from the anus≤);
  • The patient consents to participate in the clinical study and signs the informed consent form.

You may not qualify if:

  • Patients with significant local or systemic severe infection;
  • Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;
  • Have a systemic underlying disease that has not been controlled, or is unstable; Patients with poor constitution or serious other organic diseases who cannot tolerate anesthesia and surgery;
  • Women during pregnancy, perinatal and lactation;
  • Patients who are mentally incapable or unable to understand the requirements of the study;
  • Patients who participated in other clinical studies 6 weeks before the start of this study or at the same time;
  • The life expectancy of patients with malignant tumors is less than 6 months;
  • Those who are critically ill and find it difficult to make an accurate evaluation of the effectiveness and safety of the device;
  • Patients with diseases who are believed not suitable to participate in this clinical study;
  • Have other diseases that are against anastomosis;
  • The patient is receiving hormone therapy or immunosuppressive therapy;
  • Albumin\< 30g/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2023

First Posted

May 30, 2023

Study Start

July 1, 2021

Primary Completion

July 31, 2022

Study Completion

March 31, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

CN(1)