Rectosigmoid AdenocarcinomaNCT03557528
Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Cancer
An observational study of Rectosigmoid Adenocarcinoma, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectosigmoid Adenocarcinoma
- What is being tested?
- Laparoscopic colorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 30 Apr 2017
- 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: All patients affectced by clinical stage I-III cancer of sigmoid and rectum.
Who may be able to join
- stage I-III carcinoma
Who cannot join
- stage IV
- Urgent resection
- conversion to open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Tumors
During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. The aim of this retrospective evaluation is to compare high and low IMA ligation with preservation of LCA, with or without skeletonization of the origin of IMA in laparoscopic colorectal resection.
- Conditions
- Rectosigmoid Adenocarcinoma
- Being tested
- Laparoscopic colorectal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colorectal resectionProcedure or surgery
Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | High Ligation of Inferior mesenteric artery Receives: Procedure: Laparoscopic colorectal resection | |
| Group 2 | Low ligation of inferior mesenteric artery with skeletonization at its origin Receives: Procedure: Laparoscopic colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectivenes of lymphnode dissection
number of dissected lymphnodes
Measured: 3 years
Secondary outcomes (1)
complication
incidence of anasthomotic leaks
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectosigmoid AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DANIELE CROCETTI, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557528
- Sponsor's protocol ID
- 14ur2018
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- 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 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Tumors
- ClinicalTrials.gov ID
- NCT03557528
- Acronym / sponsor ID
- 14ur2018
- Conditions
- Rectosigmoid Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 15 Jun 2018 (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.
During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. The aim of this retrospective evaluation is to compare high and low IMA ligation with preservation of LCA, with or without skeletonization of the origin of IMA in laparoscopic colorectal resection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Laparoscopic colorectal resectionHigh Ligation of Inferior mesenteric artery |
| Group 2 | – | Procedure: Laparoscopic colorectal resectionLow ligation of inferior mesenteric artery with skeletonization at its origin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients affectced by clinical stage I-III cancer of sigmoid and rectum.
Key inclusion criteria (1 listed)
- stage I-III carcinoma
Key exclusion criteria (3 listed)
- stage IV
- Urgent resection
- conversion to open surgery
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 |
|---|---|---|
| Laparoscopic colorectal resectionGruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes | Procedure or surgery | Group 1, Group 2 |
Primary outcome
effectivenes of lymphnode dissection
Time frame: 3 years
number of dissected lymphnodes
1 secondary outcome
complication
Time frame: 3 years
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 15 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Rectosigmoid Adenocarcinoma
Active, not recruitingObservational study
Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer
Locally Advanced Rectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma
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 Rectosigmoid Adenocarcinoma, run by University of Roma La Sapienza 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 1 inclusion and 3 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 15 Jun 2018. 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?
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?
effectivenes of lymphnode dissection (time frame: 3 years). 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 15 Jun 2018.