Cross-sectional Study of Anorectal Function and Quality o... | NCT04697303

Studies
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

NCT04697303

Sponsor

Quan Wang

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

anorectal function test

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

Apr 2021

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

Oct 26, 2020Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Mar 28, 2021Actual

First Submitted Date

Jan 1, 2021

First Submission Date that Met QC Criteria

Jan 5, 2021

First Posted Date

Jan 6, 2021Actual

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

Apr 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Understanding the quality of life and anorectal function changes in patients with middle and low rectal cancer after surgery can guide patients to recover after surgery and provide a valuable reference for surgeons in the selection of surgical methods. The purpose of this study is to: (1) Investigate the complication rate, recurrence and metastasis rate and survival of patients with middle and low rectal cancer. (2) QLQ-C30 and QLQ-CR29 questionnaires were used to assess the quality of life of patients with low- and middle-level rectal cancer at different periods after surgery. (3) Wexner constipation score and LARS syndrome score for anorectal function after operation for low rectal cancer. (4) The CIPE ejaculatory function score, IIEF-5 International Erectile Function Score, and FSFI-6 Female Sexual Function Index were used to assess the changes in sexual function of patients with low- and middle-position rectal cancer after surgery.

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Middle and low rectal cancer			Other: anorectal function test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anorectal function test	Other	anorectal function test	Middle and low rectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	defined as time from the date of sugery to death	five years after the operation

Secondary Outcomes

Measure	Description	Time Frame
QLQ-C30	the score of Quality of life questionnaire QLQ-C30	Every three months after the operation
QLQ-CR29	the score of Quality of life questionnaire QLQ-C29

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postoperative patients with middle rectal cancer
Postoperative patients with low rectal cancer

Exclusion Criteria:

(1)Patients refused to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Postoperative patients with middle and low rectal cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jilin University First Hospital		Changchun	Jilin	130021	China

IPD Sharing Statement Module

Plan to Share IPD

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