Colorectal SurgeryPhase 3NCT00773981
Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection
A Phase 3 study testing Transrectal vacuum assisted drainage in people with Colorectal Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Transrectal vacuum assisted drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, Hvidovre, 2650
Kathrine Holte, MD
About this study
Official title: Transrectal Vacuum Assisted Drainage: A NEW METHOD OF TREATING ANASTOMOTIC LEAKAGE AFTER RECTAL RESECTION. A Prospective Randomized Multicenter Study in Cooperation With "The Danish Colorectal Cancer Group"
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.
- Conditions
- Colorectal Surgery
- Being tested
- Transrectal vacuum assisted drainage
- Keywords
- anastomotic leakage
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transrectal vacuum assisted drainageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Endoluminal vacuum therapy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time of the anastomotic leakage
Measured: 1 year
Secondary outcomes (6)
Salvage surgery (abdominal reoperation with debridement of anastomosis)
Measured: 1 month
Duration of fever and antibiotic treatment
Measured: 2 months
Duration of hospital stay
Measured: 2 monts
Number of visits in the outpatient clinic / number of sponge changes
Measured: 8 weeks
Functional result, defined as +/- closure of temporary ileostomy
Measured: 2 years
Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Braun Aesculap
- Investigators
- Carl F Nagell, MD, Principal investigator, Hamlet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773981
- Sponsor's protocol ID
- H-B-2007-061
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transrectal Vacuum Assisted Drainage: A NEW METHOD OF TREATING ANASTOMOTIC LEAKAGE AFTER RECTAL RESECTION. A Prospective Randomized Multicenter Study in Cooperation With "The Danish Colorectal Cancer Group"
- ClinicalTrials.gov ID
- NCT00773981
- Acronym / sponsor ID
- H-B-2007-061
- Conditions
- Colorectal Surgery
- Keywords
- anastomotic leakage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Braun Aesculap
- Study start
- Oct 2008
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Transrectal vacuum assisted drainageEndoluminal vacuum therapy. |
| 2 | No intervention | –Patients not receiving vacuum therapy should be treated with a catheter with daily rinsing for a minimum of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- Informed consent
- Age < 18 years
- Acute surgery
- Leakage diagnosed more than 21 days after the primary operation
- Patient does not consent to temporary ileostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transrectal vacuum assisted drainageTreatment 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. | Procedure or surgery | 1 |
Primary outcome
Healing time of the anastomotic leakage
Time frame: 1 year
6 secondary outcomes
Salvage surgery (abdominal reoperation with debridement of anastomosis)
Time frame: 1 month
Duration of fever and antibiotic treatment
Time frame: 2 months
Duration of hospital stay
Time frame: 2 monts
Number of visits in the outpatient clinic / number of sponge changes
Time frame: 8 weeks
Functional result, defined as +/- closure of temporary ileostomy
Time frame: 2 years
Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl F Nagell, MD principal investigator
Hamlet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transrectal vacuum assisted drainage in people with Colorectal Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl F Nagell, MD (+ 45 44443343, rikke.frederik@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time of the anastomotic leakage (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2008.