Anastomotic Leak RectumOBANORESNCT05293054
Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery
An observational study of Anastomotic Leak Rectum and Rectal Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak Rectum, Rectal Cancer, Anastomotic Leakage
- What is being tested?
- Application of autologous fibrin matrix (Obsidian)
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2021to 8 Nov 2023
- Phase
- Observational
- 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
Study population: Patients with biopsy proven rectal cancer subjected to minimally invasive rectal resection with anastomosis (TME or PME).
Who may be able to join
- Primary rectal cancer (adenocarcinoma) with the lower boarder within 15 cm from the anal verge assessed by rigid proctoscopy
- Clinical UICC stage I-III at time of rectal cancer diagnosis
- Deemed suitable for intended curative rectal cancer resection at MDT either by total mesorectal excision (TME) or partial mesorectal excision (PME)
- Scheduled for elective, minimal invasive surgery
- ECOG performance status 0-2
- Age at least 18 years
- Written and orally informed consent
Who cannot join
- Distant metastatic disease
- Locally advanced rectal cancer requiring extended resection
- Open surgery
- Benign lesions of the rectum
- Inflammatory bowel disease
- Another malignant disease within previous 2 years
- Inability and unwillingness to give informed consent
- Pregnant (positive pregnancy test) or breast feeding women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgery, Aarhus University Hospital
Aarhus, Central Jutland, 8200
About this study
Official title: Obsidian in Anastomotic Healing After Rectal Cancer Resection: A Prospective Clinical Feasibility Study
Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. However, in 10-15% of cases, this anastomosis doesn't heal completely, leading to anastomotic leakage. This is a serious complication, with detrimental effects for the individual patient. Previous measures to avoid this complication, have proven unsuccessful.
Obsidian is a mixture derived from the patients' own blood, that contains components of blood normally responsible for stopping bleeding and kickstarting the healing process. It is already used in other clinical settings and preliminary, yet unpublished, results from a pilot study have shown its promise in decreasing the risk of anastomotic leakage in rectal anastomosis. However, its use has not been examined when performing surgery for rectal cancer with minimally invasive technique, which is today's standard.
Read more
The main clinical hypothesis of this feasibility study is that it is possible for colorectal surgeons to apply Obsidian successfully on the anastomotic area with minimal invasive technique, as a supplement during rectal cancer resection with anastomosis.
This study will be conducted at the Department of Surgery, Aarhus University Hospital. 50 patients will be included, who will undergo minimally invasive rectal cancer surgery with an anastomosis. Right after the onset of anaesthesia, 120 ml of blood will be collected from the patient and will be processed, making a 5-6 ml Obsidian concentrate. When the tumor-bearing part of the rectum has been removed, Obsidian will be applied, according to a pre-specified protocol.
If the application is deemed successful (based on predefined assessment criteria) in at least 90% of our included patients, then this study will serve as a stepping stone for a bigger study, the aim of which will be to assess if this method can indeed bring down the rate of anastomotic leakage in such patients.
- Conditions
- Anastomotic Leak Rectum, Rectal Cancer, Anastomotic Leakage
- Being tested
- Application of autologous fibrin matrix (Obsidian)
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of autologous fibrin matrix (Obsidian)Other
When the patient is anaesthetized, 120 ml venous blood is collected for preparation of the autologous fibrin matrix. The blood is processed in the Vivostat® unit for 30 minutes making a 5-6 ml concentrate ready for application by use of a specific endoscopic kit device.
When the rectal cancer resection is completed and the specimen is extracted, the Obsidian will be applied using minimal invasive technique and the endoscopic kit device.
Step 1: 1.5-2ml. Obsidian is applied onto the rectal stump, with the circular stapler device inserted into the rectal stump. The circular stapler is then closed, but not yet fired.
Step 2: 2.5-3ml Obsidian is applied 360 degrees around the anastomosis, while taking care not to increase tension on the anal intestine end. The circular stapler is then fired and removed. The water-air-leak test is performed according to standard clinical practice. Step 3: The remaining part of the Obsidian is then sealed 360 degrees around the anastomosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique
Defined as the surgeon being able re-inforce the anastomosis with Obsidian as described in our protocol. Assessment of the Obsidian application must be graded using the following rating assessment scale:
'Complete'
'Almost complete'
'Incomplete'
Each of these are detailed in the study protocol.
To be able to view the use of Obsidian application as a successful method, then the application should be rated as 'Complete' or 'Almost complete' in at least 45 out of 50 (90%) patients.
Measured: This outcome is measured during the intervention.
Secondary outcomes (7)
Time spent for creating a rectal anastomosis with application of Obsidian
Time spent for creating the anastomosis with application of Obsidian is defined as: Time spent from inserting the circular stapler device in the rectal stump (Shortly before the start of Step 1 in Intervention Details), until the application around the circular anastomosis has been completed (End of Step 3 in Intervention Details).
Measured: This outcome is measured during the intervention.
The surgeon's self-assessment of the user-friendliness of using Obsidian
Surgeon's self-assessment of the user-friendliness of using Obsidian is graded in three grades: 1. Easy, 2. Difficult, but can be performed, 3. Very difficult
Measured: This outcome is measured immediately after the intervention.
Anastomotic leak rate
Anastomotic leak is defined according to the definition as described by Rahbari NN.
Measured: Measured within 30 days after surgery
Length of hospital stay
Calculated as number of days
Measured: From, and including, day of surgery to, and including, day of discharge, or up to 90 days after surgery.
Re-hospitalization within 30 days after surgery
All re-hospitalizations at departments of any kind at hospitals in Central Denmark Region after surgery will be recorded, including reason for re-hospitalization.
Measured: Measured within 30 days after surgery
Morbidity within 30 days after surgery graded ≥3 severity according to the Clavien-Dindo classification
Morbidity within 30 days after surgery include surgical and medical complications graded ≥2 severity according to the Clavien-Dindo classification, will be recorded.
Surgical complications include bleeding, fascia dehiscence, ileus, surgical site infection, intra-abdominal abscess, and anastomotic leakage. Medical complications include cerebral complications (transitory ischemic attack, stroke), pulmonary complications (pneumonia, atelectasis, pleural effusion), cardiac complications (atrial fibrillation, acute myocardial infarction, heart failure), gastrointestinal complications (high stoma output, paralysis >4 days), urogenital complications (urinary tract infections, urinary retention, acute kidney insufficiency), thromboembolic complications (deep venous thrombosis, pulmonary embolism).
Measured: Measured within 30 days after surgery
2-year mortality
For safety reasons, mortality within 2 years after surgery will be recorded.
Measured: Within 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Dec 2021
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anastomotic Leak RectumStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Lene H Iversen, DMSc, PhD, Principal investigator, Department of Surgery, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293054
- Sponsor's protocol ID
- VEK: 1-10-72-187-20
- Acronym
- OBANORES
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
PubMed 20004450
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obsidian in Anastomotic Healing After Rectal Cancer Resection: A Prospective Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT05293054
- Acronym / sponsor ID
- OBANORES / VEK: 1-10-72-187-20
- Conditions
- Anastomotic Leak Rectum, Rectal Cancer, Anastomotic Leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- 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.
Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. However, in 10-15% of cases, this anastomosis doesn't heal completely, leading to anastomotic leakage. This is a serious complication, with detrimental effects for the individual patient. Previous measures to avoid this complication, have proven unsuccessful.
Obsidian is a mixture derived from the patients' own blood, that contains components of blood normally responsible for stopping bleeding and kickstarting the healing process. It is already used in other clinical settings and preliminary, yet unpublished, results from a pilot study have shown its promise in decreasing the risk of anastomotic leakage in rectal anastomosis. However, its use has not been examined when performing surgery for rectal cancer with minimally invasive technique, which is today's standard.
The main clinical hypothesis of this feasibility study is that it is possible for colorectal surgeons to apply Obsidian successfully on the anastomotic area with minimal invasive technique, as a supplement during rectal cancer resection with anastomosis.
This study will be conducted at the Department of Surgery, Aarhus University Hospital. 50 patients will be included, who will undergo minimally invasive rectal cancer surgery with an anastomosis. Right after the onset of anaesthesia, 120 ml of blood will be collected from the patient and will be processed, making a 5-6 ml Obsidian concentrate. When the tumor-bearing part of the rectum has been removed, Obsidian will be applied, according to a pre-specified protocol.
If the application is deemed successful (based on predefined assessment criteria) in at least 90% of our included patients, then this study will serve as a stepping stone for a bigger study, the aim of which will be to assess if this method can indeed bring down the rate of anastomotic leakage in such patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven rectal cancer subjected to minimally invasive rectal resection with anastomosis (TME or PME).
Key inclusion criteria (7 listed)
- Primary rectal cancer (adenocarcinoma) with the lower boarder within 15 cm from the anal verge assessed by rigid proctoscopy
- Clinical UICC stage I-III at time of rectal cancer diagnosis
- Deemed suitable for intended curative rectal cancer resection at MDT either by total mesorectal excision (TME) or partial mesorectal excision (PME)
- Scheduled for elective, minimal invasive surgery
- ECOG performance status 0-2
Key exclusion criteria (8 listed)
- Distant metastatic disease
- Locally advanced rectal cancer requiring extended resection
- Open surgery
- Benign lesions of the rectum
- Inflammatory bowel disease
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 |
|---|---|---|
| Application of autologous fibrin matrix (Obsidian)When the patient is anaesthetized, 120 ml venous blood is collected for preparation of the autologous fibrin matrix. The blood is processed in the Vivostat® unit for 30 minutes making a 5-6 ml concentrate ready for application by use of a specific endoscopic kit device. When the rectal cancer resection is completed and the specimen is extracted, the Obsidian will be applied using minimal invasive technique and the endoscopic kit device. Step 1: 1.5-2ml. Obsidian is applied onto the rectal stump, with the circular stapler device inserted into the rectal stump. The circular stapler is then closed, but not yet fired. Step 2: 2.5-3ml Obsidian is applied 360 degrees around the anastomosis, while taking care not to increase tension on the anal intestine end. The circular stapler is then fired and removed. The water-air-leak test is performed according to standard clinical practice. Step 3: The remaining part of the Obsidian is then sealed 360 degrees around the anastomosis. | Other | – |
Primary outcome
The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique
Time frame: This outcome is measured during the intervention.
Defined as the surgeon being able re-inforce the anastomosis with Obsidian as described in our protocol. Assessment of the Obsidian application must be graded using the following rating assessment scale: 'Complete' 'Almost complete' 'Incomplete' Each of these are detailed in the study protocol. To be able to view the use of Obsidian application as a successful method, then the application should be rated as 'Complete' or 'Almost complete' in at least 45 out of 50 (90%) patients.
7 secondary outcomes
Time spent for creating a rectal anastomosis with application of Obsidian
Time frame: This outcome is measured during the intervention.
The surgeon's self-assessment of the user-friendliness of using Obsidian
Time frame: This outcome is measured immediately after the intervention.
Anastomotic leak rate
Time frame: Measured within 30 days after surgery
Length of hospital stay
Time frame: From, and including, day of surgery to, and including, day of discharge, or up to 90 days after surgery.
Re-hospitalization within 30 days after surgery
Time frame: Measured within 30 days after surgery
Morbidity within 30 days after surgery graded ≥3 severity according to the Clavien-Dindo classification
Time frame: Measured within 30 days after surgery
2-year mortality
Time frame: Within 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 20004450Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
- Individual participant dataSharing planned: No
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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.
Lene H Iversen, DMSc, PhD principal investigator
Department of Surgery, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak Rectum and Rectal Cancer, run by University of Aarhus 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique (time frame: This outcome is measured during the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293054, which also lists 1 linked publication.
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 27 Mar 2024.