the Value of Transanal Endoscopic ISR | NCT05933785

Studies
the Value of Transanal Endoscopic ISR

NCT05933785

Sponsor

Shanghai Minimally Invasive Surgery Center

Status

Completed

Last Update Posted

Mar 7, 2024Actual

Enrollment

260Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

transanal endoscopic ISR

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

May 30, 2023Actual

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transanal endoscopic ISR			Procedure: transanal endoscopic ISR
traditional ISR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transanal endoscopic ISR	Procedure	perform ISR using laparoscopy through transanal port	transanal endoscopic ISR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anal preservation rate	No conversion to APR and closure was closed within 1 year after surgery	1 year after sugery

Secondary Outcomes

Measure	Description	Time Frame
incidence of Defecation disorders	A Wexner score >10 indicated the existence of defecation dysfunction	6 months after surgery
incidence of positive distal resection margin	A positive distal resection margin (DRM) was diagnosed with the presence of tumor cells within 1mm from the DRM

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 75 years
American Society of Anesthesiologists (ASA) score I to III
A biopsy proven histological diagnosis of rectal carcinoma
preoperative stage as (y) cT1-3N0-2M0
lower margin of the tumor less than 5cm from the anus
tumor diameter ≤5cm

Exclusion Criteria:

Pregnant or lactating women
Synchronous rectal carcinoma
History of colorectal cancer or other malignant tumors
Clinical evidence of metastasis
Emergency procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patient with low and ultra-low rectal cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital		Shanghai		200025	China
Shanghai Minimally Invasive Surgery Center

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided