Obesity, MorbidNCT06056726
Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients
An observational study of Obesity, Morbid and Rectal Cancer, run by Federico II University at 1 site in Italy.
Trial summary
Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Morbid, Rectal Cancer, Surgery-Complications
- What is being tested?
- BIB positioning
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2021to 18 Feb 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients, with locally advanced rectal cancer in clinical stage II-III, candidates for neoadjuvant therapy, who can underwent BIB positioning during neoadjuvant period to obtain weight loss before resective cancer surgery
Who may be able to join
- Patients with locally advanced rectal cancer in clinical stage II-III according to AJCC-UICC 2017 (candidates for neoadjuvant therapy)
- Patients suffering from I, II and III degree obesity at the same time
- Age between 18 and 70 years old
- BMI between 31 and 55 kg/m2
- Non-Smoking
- Candidates, according to AIOM guidelines, for rectal resection surgical procedures
- Candidates, according to SICOB guidelines, for an intragastric balloon placement procedure
Who cannot join
- Age ≤ 18 or ≥ 70 years
- BMI ≤ 30 or ≥ 59 Kg/m2
- Smoker
- Patients with non-locally advanced rectal cancer, not eligible for neoadjuvant therapy
- Histological positivity to Helicobacter pylori
- Presence of ulcerative lesions on EGD
- Previous bariatric surgery treatments
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Nunzio Velotti
Naples, 80131
Nunzio Velotti, +3921417424, nunzio.velotti@gmail.com
About this study
Official title: Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery
Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.
Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective, alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.
Read the detailed description
Epidemiological data show that obesity is associated with a 30-70% increase in the risk of developing rectal cancer; Obesity could also be associated with a worsening of the tumor prognosis, with an increased risk of recurrence and increased mortality. From this point of view, recent studies have shown that a BMI ≥ 30 kg/m2 is associated with higher oncological and functional risks in patients with locally advanced rectal cancer, with lower response rates to neoadjuvant treatment and a less frequent preservation of the anal sphincter.
Obesity also worsens treatment outcomes: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.
The most recent studies on the subject have shown that IGBs are effective in producing weight loss ranging from 6% to 15% compared to 1% -5% produced by lifestyle interventions alone Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective (reduction of intra- and peri-operative complications, increased disease-free survival and lower risk of long-term recurrence) is underlined. ), alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.
- Conditions
- Obesity, Morbid, Rectal Cancer, Surgery-Complications
- Being tested
- BIB positioning
- Keywords
- Bariatric Surgery, Oncological surgery
- Medical subject headings
- Obesity, Morbid, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIB positioningProcedure or surgery
BIB positioning in obese patients with rectal cancer elegible for neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Obese Patients | Patients candidates for resective surgery for rectal cancer and also elegible for bariatric surgery Receives: Procedure: BIB positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative complications
Peri-operative complications during rectal cancer surgery
Measured: Intra-operative complications and complications within 30 days from surgery
Secondary outcomes (1)
Overall survival
Overall survival for patients with rectal cancer underwent resective surgery after BIB positioning
Measured: 3 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 posted28 Sep 2023
- Study start18 Feb 2021
- Primary completion18 Feb 2024 (estimated)
- Study completion18 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Musella MD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056726
- Sponsor's protocol ID
- RettOb
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06056726
- Acronym / sponsor ID
- RettOb
- Conditions
- Obesity, Morbid, Rectal Cancer, Surgery-Complications
- Keywords
- Bariatric Surgery, Oncological surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 18 Feb 2024 (estimated)
- Study completion
- 18 Feb 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.
Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective, alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.
Detailed description
Epidemiological data show that obesity is associated with a 30-70% increase in the risk of developing rectal cancer; Obesity could also be associated with a worsening of the tumor prognosis, with an increased risk of recurrence and increased mortality. From this point of view, recent studies have shown that a BMI ≥ 30 kg/m2 is associated with higher oncological and functional risks in patients with locally advanced rectal cancer, with lower response rates to neoadjuvant treatment and a less frequent preservation of the anal sphincter.
Obesity also worsens treatment outcomes: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss.
The most recent studies on the subject have shown that IGBs are effective in producing weight loss ranging from 6% to 15% compared to 1% -5% produced by lifestyle interventions alone Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective (reduction of intra- and peri-operative complications, increased disease-free survival and lower risk of long-term recurrence) is underlined. ), alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Patients | – | Procedure: BIB positioningPatients candidates for resective surgery for rectal cancer and also elegible for bariatric surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients, with locally advanced rectal cancer in clinical stage II-III, candidates for neoadjuvant therapy, who can underwent BIB positioning during neoadjuvant period to obtain weight loss before resective cancer surgery
Key inclusion criteria (7 listed)
- Patients with locally advanced rectal cancer in clinical stage II-III according to AJCC-UICC 2017 (candidates for neoadjuvant therapy)
- Patients suffering from I, II and III degree obesity at the same time
- Age between 18 and 70 years old
- BMI between 31 and 55 kg/m2
- Non-Smoking
Key exclusion criteria (7 listed)
- Age ≤ 18 or ≥ 70 years
- BMI ≤ 30 or ≥ 59 Kg/m2
- Smoker
- Patients with non-locally advanced rectal cancer, not eligible for neoadjuvant therapy
- Histological positivity to Helicobacter pylori
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 |
|---|---|---|
| BIB positioningBIB positioning in obese patients with rectal cancer elegible for neoadjuvant therapy | Procedure or surgery | Obese Patients |
Primary outcome
Peri-operative complications
Time frame: Intra-operative complications and complications within 30 days from surgery
Peri-operative complications during rectal cancer surgery
1 secondary outcome
Overall survival
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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.
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 Obesity, Morbid and Rectal Cancer, run by Federico II University at 1 site in Italy.
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 7 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 29 Sep 2023. 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 Italy. 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?
Contact Mario Musella, MD (+390817462880, mario.musella@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative complications (time frame: Intra-operative complications and complications within 30 days from surgery). 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 29 Sep 2023.