Conventional Laparoscopic APR Versus Laparoscopic APR Wit... | NCT02812628

Studies
Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection

NCT02812628

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Jun 24, 2016Estimated

Enrollment

528Estimated

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

LAPR
LAPR-TILT

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Jun 10, 2016

First Submission Date that Met QC Criteria

Jun 21, 2016

First Posted Date

Jun 24, 2016Estimated

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

Jun 21, 2016

Last Update Posted Date

Jun 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).

Detailed Description

In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.

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

528Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional LAPR	Active Comparator	Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR).	Procedure: LAPR
LAPR-TILT	Experimental	Patients undergoing LAPR with transabdominal individualized levator transection (TILT).	Procedure: LAPR-TILT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LAPR	Procedure	Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.	Conventional LAPR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-year local recurrence		3 years post operation

Secondary Outcomes

Measure	Description	Time Frame
3-year overall survival		3 years post operation
3-year disease-free survival		3 years post operation

Other Outcomes

Measure	Description	Time Frame
Operative time for perineal dissection		1 month post operation
Numbers of days to remove the urinary catheter after surgery		1 month post operation
Circumferential Resection Margin (+) rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
Patients undergoing elective, radial surgery with no distant metastasis.
Patients with Body Mass Index (BMI) between 18-30kg/m2.
Patients who agree to undergo standard adjuvant treatment after surgery.
Patients who have fully understood the aim of the trial and have signed the written informed consent.

Exclusion Criteria:

Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
Patients undergoing emergent surgery.
Pregnant patients.
Patients with tumors other than rectal tumor.
Patients with severe comorbid diseases which preclude surgery.
Patients in bad conditions and do not ameliorate before surgery.
Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.
Patients who refuse to accept standard adjuvant surgery.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bo Feng, M.D. Ph.D	Contact	86-21-64370045		fengbo2022@163.com

Overall Officials

Name	Affiliation	Role
Bo Feng, Ph.D	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine	Recruiting	Shanghai	Shanghai Municipality	200025	China

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