Transrectal Vacuum Assisted Drainage: A New Method of Tre... | NCT00773981

Studies
Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

NCT00773981

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Nov 4, 2008Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Colorectal Surgery

Interventions

Transrectal vacuum assisted drainage

Countries

Denmark

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

Oct 2008

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

Oct 2008

Primary Completion Date

Oct 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 16, 2008Estimated

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

Nov 3, 2008

Last Update Posted Date

Nov 4, 2008Estimated

Name	Class
Braun Aesculap	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative treatment with transrectal rinsing. This treatment is often associated with a very protracted postoperative course with healing times of up to a year or more for the anastomotic leakage.

Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy.

The objective of this study is to investigate the effects of transrectal vacuum treatment on the healing of anastomotic leakage after rectum resection in a prospective, randomized, controlled multicentre trial in 60 patients found to develop clinically significant anastomotic leakages after elective rectal resection.

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Endoluminal vacuum therapy.	Procedure: Transrectal vacuum assisted drainage
2	No Intervention	Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transrectal vacuum assisted drainage	Procedure	Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy. The principle of the method is application of negative pressure on the wound surface with the help of a sponge that is connected to a pump. Sponge dressings should be changed 3 times pr week as long as vacuum therapy is used. If there has been no development of granulation tissue or no shrinking of the cavity in 3 weeks Vacuum therapy can be stopped. Maximum vacuum therapy is 8 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing time of the anastomotic leakage		1 year

Secondary Outcomes

Measure	Description	Time Frame
Salvage surgery (abdominal reoperation with debridement of anastomosis)		1 month
Duration of fever and antibiotic treatment		2 months
Duration of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with clinically significant* anastomotic leakage after intended curative rectal resection (LAR) for rectal cancer with primary anastomosis.
Patients whose operation did not include ileostomy must have surgery to create a stoma within two days after beginning of the vacuum therapy and before randomization. Anastomotic leakage must have been diagnosed within 21 days of the primary operation.
Patients with and without preoperative radiation therapy may participate.
Groups will be formed accordingly, because patients who had preoperative radiation therapy heal more slowly.
Patients with anastomotic leakage (diagnosed by endoscopic or radiology techniques) and clinical signs and symptoms indicating a health impairment (fever, pain, elevated creatinine levels).
Anastomotic leakage after rectal cancer surgery

Exclusion Criteria:

Informed consent
Age < 18 years
Acute surgery
Leakage diagnosed more than 21 days after the primary operation
Patient does not consent to temporary ileostomy
Anastomosis technically inaccessible for vacuum-assisted drainage
Small intestine visible in abscess cavity
Residual cancer tissue in the pelvic cavity
Suspicion of fistulation between the abscess cavity and internal genitalia, urinary tract system, or small intestines.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carl F Nagell, MD	Contact	+ 45 44443343		rikke.frederik@dadlnet.dk
Kathrine Holte, MD	Contact	+ 45 51903229		kathrine.holte@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Carl F Nagell, MD	Hamlet Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital	Recruiting	Hvidovre	Hvidovre	2650	Denmark

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms