Resection Location of Rectum in Laparoscopic Surgery for... | NCT04525248

Studies
Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

NCT04525248

Sponsor

Shanghai Minimally Invasive Surgery Center

Status

Unknown status

Last Update Posted

Aug 25, 2020Actual

Enrollment

78Estimated

Phase

Not Applicable

Conditions

Slow Transit
Constipation

Interventions

Laparoscopic total colectomy + low resection of rectum
Laparoscopic total colectomy + High resection of rectum

Countries

Not provided

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Aug 1, 2024Estimated

First Submitted Date

Aug 18, 2020

First Submission Date that Met QC Criteria

Aug 23, 2020

First Posted Date

Aug 25, 2020Actual

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

Aug 23, 2020

Last Update Posted Date

Aug 25, 2020Actual

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

Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum

Detailed Description

The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12~15cm from anus and low resection as 6~8cm.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High resection	Active Comparator	Laparoscopic total colectomy + High resection of rectum	Procedure: Laparoscopic total colectomy + High resection of rectum
Low resection	Experimental	Laparoscopic total colectomy + Low resection of rectum	Procedure: Laparoscopic total colectomy + low resection of rectum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic total colectomy + low resection of rectum	Procedure	Laparoscopic total colectomy + low resection of rectum	Low resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1-year recurrence rate of constipation	1-year recurrence rate of constipation	1 year

Secondary Outcomes

Measure	Description	Time Frame
1-year rate of diarrhea	1-year rate of diarrhea	1 year
perioperative complications	perioperative complications	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as constipation according to Rome IV criteria
Diagnosed as slow transit constipation
With more than 2 years' drug treatment or with outlet obstruction or with surgical history

Exclusion Criteria:

Colon cancer
History of colon, rectum, anus surgery
With severe cardio, renal, neural disease
Pregnant patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Junjun Ma, Dr	Contact	+86 13917283686		marsnew1997@163.com
Xuan Zhao, Dr	Contact	+86 15900826056		patrickzhao_sjtu@163.com

Overall Officials

Name	Affiliation	Role
Minhua Zheng	Shanghai MISC	Study Chair

Locations

Not provided

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
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided