Rectal CancerNCT02153853
Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?
An observational study of Rectal Cancer and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications. The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Obesity
- How many people
- 335 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rectal cancer treated with laparoscopic surgery at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Denmark.
Who may be able to join
- Patients with rectal cancer undergoing laparoscopic surgery, Hvidovre Hospital, Denmark.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications.
The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer.
The investigators main outcome measure will be the conversion rate, and the investigators also intend to study other indications of short term complications, such as peroperative bleeding, infection, re-operation and mortality.
The investigators hypothesise that increased BMI does not increase the risk of conversion.
- Conditions
- Rectal Cancer, Obesity
- Medical subject headings
- Rectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer | Patients undergoing laparoscopic surgery for rectal cancer at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Amount of patients undergoing conversion from laparoscopic to open surgery.
Measured: Day 1
Secondary outcomes (6)
Peroperative Bleeding
Peroperative blood loss measured in mL.
Measured: Day 1
Length of Hospital Stay
Days in hospital after surgery.
Measured: Time of Discharge (3-80 days after surgery, mean: 11 days)
Short term complications
Complications at the time of discharge classified according to Clavien Dindo, groups 0-5.
Measured: Time of Discharge (3-80 days after surgery, mean: 11 days)
Readmission within 30 days after surgery
+/- Readmission to the Gastrointestinal Surgical ward within 30 days after initial discharge.
Measured: 30 days after discharge
30-day mortality
Measured: 30 days after surgery
Duration of surgery
Duration of surgery measured in minutes.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amalie Bøggild, MD, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153853
- Sponsor's protocol ID
- BMIandRectalCancer
- Status last verified
- Jan 2015
- First submitted
- 29 May 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?
- ClinicalTrials.gov ID
- NCT02153853
- Acronym / sponsor ID
- BMIandRectalCancer
- Conditions
- Rectal Cancer, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Jun 2014 (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.
Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications.
The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer.
The investigators main outcome measure will be the conversion rate, and the investigators also intend to study other indications of short term complications, such as peroperative bleeding, infection, re-operation and mortality.
The investigators hypothesise that increased BMI does not increase the risk of conversion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer | – | –Patients undergoing laparoscopic surgery for rectal cancer at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rectal cancer treated with laparoscopic surgery at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Denmark.
Key inclusion criteria (1 listed)
- Patients with rectal cancer undergoing laparoscopic surgery, Hvidovre Hospital, Denmark.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conversion rate
Time frame: Day 1
Amount of patients undergoing conversion from laparoscopic to open surgery.
6 secondary outcomes
Peroperative Bleeding
Time frame: Day 1
Length of Hospital Stay
Time frame: Time of Discharge (3-80 days after surgery, mean: 11 days)
Short term complications
Time frame: Time of Discharge (3-80 days after surgery, mean: 11 days)
Readmission within 30 days after surgery
Time frame: 30 days after discharge
30-day mortality
Time frame: 30 days after surgery
Duration of surgery
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Hvidovre HospitalLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rectal Cancer and Obesity, 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 1 inclusion and 1 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 26 Jan 2015. 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?
Results are not available in the source record.
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?
Conversion rate (time frame: Day 1). 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 26 Jan 2015.