AdhesionsALIVENCT01720966
Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection
An observational study of Adhesions, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial summary
Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Adhesions
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 6 sitesNetherlands
- Study dates
- Jan 2013to Oct 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases in the before mentioned centers will be assessed for eligibility. The planned number of patients will be recruited in approximately 1 year.
Who may be able to join
- laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases
- laparoscopy or laparotomy for colorectal malignancy in history
- age ≥18 years
Who cannot join
- a history of abdominal surgery with a high risk of adhesions either before resection of the primary tumour or during the interval between resection of the primary tumour and liver resection. These high risk surgeries are:
- Colorectal surgery
- Ovarian surgery
- Abdominal wall surgery
- mental incompetence
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Gelre Ziekenhuis
Apeldoorn
Ziekenhuis Gelderse Vallei
Ede
Maastricht University Medical Center
Maastricht
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland
Daniel de hoed kliniek
Rotterdam
Maxima Medisch Centrum
Veldhoven
About this study
Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.
Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases.
Read more
Study design: The study is designed as a prospective observational cohort study.
Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.
Main study parameters/endpoints:
- Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision.
- Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose.
Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.
- Conditions
- Adhesions
- Being tested
- Liver resection
- Keywords
- Adhesions, laparoscopy, laparotomy, liver resection, colorectal malignancy
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Liver resection performed for metastatic disease from colorectal carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation. Receives: Procedure: Liver resection | |
| Laparotomy | Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation. Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adhesion to ventral abdominal wall
To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.
Measured: peroperative (1 day)
Secondary outcomes (7)
Incidence of adhesions
Total incidence of adhesions
Measured: peroperative (1 day)
Extent of adhesions
Extent of adhesions
Measured: peroperative (1 day)
Adhesion Score
Adhesion score according to Zühlke
Measured: peroperative (1 day)
Adhesiolysis
need to perform adhesiolysis
Measured: peroperative (1 day)
Duration of adhesiolysis
Duration of adhesiolysis in minutes
Measured: peroperative (1 day)
Inadvertent bowel injury
Inadvertent bowel injury made during operation
Measured: peroperative (1 day)
Postoperative mobidity
Incidence of predetermined postoperative complications:
- mortality
- incisional wound infection
- abdominal sepsis
- pneumonia
- urinary tract infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionOct 2015
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 AdhesionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry P van Goor, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720966
- Sponsor's protocol ID
- RU-RTB-0004
- Acronym
- ALIVE
- Status last verified
- Nov 2015
- First submitted
- 24 Oct 2012
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.
PubMed 23013804
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection
- ClinicalTrials.gov ID
- NCT01720966
- Acronym / sponsor ID
- ALIVE / RU-RTB-0004
- Conditions
- Adhesions
- Keywords
- Adhesions, laparoscopy, laparotomy, liver resection, colorectal malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Nov 2012 (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.
Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.
Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases.
Study design: The study is designed as a prospective observational cohort study.
Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.
Main study parameters/endpoints:
- Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision.
- Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose.
Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | – | Procedure: Liver resectionPatients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation. |
| Laparotomy | – | Procedure: Liver resectionPatients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases in the before mentioned centers will be assessed for eligibility. The planned number of patients will be recruited in approximately 1 year.
Key inclusion criteria (3 listed)
- laparotomy or laparoscopy for intended liver resection or radio frequency ablation for colorectal metastases
- laparoscopy or laparotomy for colorectal malignancy in history
- age ≥18 years
Key exclusion criteria (5 listed)
- a history of abdominal surgery with a high risk of adhesions either before resection of the primary tumour or during the interval between resection of the primary tumour and liver resection. These high risk surgeries are:
- mental incompetence
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 |
|---|---|---|
| Liver resectionLiver resection performed for metastatic disease from colorectal carcinoma | Procedure or surgery | Laparoscopy, Laparotomy |
Primary outcome
Incidence of adhesion to ventral abdominal wall
Time frame: peroperative (1 day)
To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.
7 secondary outcomes
Incidence of adhesions
Time frame: peroperative (1 day)
Extent of adhesions
Time frame: peroperative (1 day)
Adhesion Score
Time frame: peroperative (1 day)
Adhesiolysis
Time frame: peroperative (1 day)
Duration of adhesiolysis
Time frame: peroperative (1 day)
Inadvertent bowel injury
Time frame: peroperative (1 day)
Postoperative mobidity
Time frame: 30 days
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 10 Nov 2015.
- Background: PubMed 23013804ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.
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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.
Harry P van Goor, MD, PhD principal investigator
Radboud University Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesions, run by Radboud University Medical Center at 6 sites in Netherlands.
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 3 inclusion and 5 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
Incidence of adhesion to ventral abdominal wall (time frame: peroperative (1 day)). 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 NCT01720966, 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 10 Nov 2015.