Colonic NeoplasmsCOATINCT04310839
Outpatient Left Laparoscopic Colectomy
An observational study of Colonic Neoplasms and Colonic Diverticulosis, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial summary
The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Colonic Diverticulosis
- What is being tested?
- Colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2020to 2 Dec 2022
- 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 taken care for a left colectomy due to colonic neoplasm or diverticulosis
Who may be able to join
- American Society of Anesthesiologists Classification (ASA) score I and II,
- Patient with an indication for scheduled left colectomy due to neoplastic (stage 1) or diverticulitis,
- Patient residing less than 30 minutes from La Rochelle hospital,
- Presence of a companion from the anaesthesia consultation onwards,
- Presence of an attendant at the patient's discharge,
- Perfect understanding of outpatient care, pathology and surgical procedure of the patient and accompanying person,
- Informed of the study.
Who cannot join
- ASA score 3 et 4,
- Indication for a straight or transverse colectomy,
- Neoplasia evolution > stage 1,
- Presence of anticoagulant treatment,
- Intraoperative bleeding > 500ml,
- Conversion to laparotomy,
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- Severe anesthetic complication (Anaphylaxis, Difficult Intubation),
- Persons deprived of their liberty by a judicial or administrative decision,
- Persons of full age who are subject to a legal protection measure,
- Persons unable to consent,
- Persons who are not members of or beneficiaries of a social security scheme,
- Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Management of Patients With a Left Laparoscopic Colectomy
The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.
Read the detailed description
In France, colectomy represents about 40,000 interventions per year, most of them scheduled, and 2/3 in a context of neoplasia. This surgery is associated with numerous postoperative complications. Since the start of Enhanced Recovery After Surgery (ERAS) in 1997, complications have been steadily reduced by optimizing surgical and anaesthetic techniques. At the same time, the average length of post-operative stay has decreased. In 2014, ERAS was the subject of recommendations by the French Society of Anaesthesia and Resuscitation, taken up by the French Health Authority (HAS) in 2016, and which are now an integral part of surgical management in colorectal surgery. More recently, two teams have set up an outpatient colectomy program. The three studies published on this subject show encouraging results, in a private structure, with no increase in postoperative complications.
In accordance with the recommendations on ERAS published by the HAS, a program involving pre-, per- and post-interventional investment, has been put in place. Patients are discharged on D0, followed by close monitoring by a home care nurse twice daily. This nurse is in charge of collecting clinical data in order to detect possible early signs of post-operative complications that would justify re-hospitalisation after a medical-surgical decision.
- Conditions
- Colonic Neoplasms, Colonic Diverticulosis
- Being tested
- Colectomy
- Medical subject headings
- Colonic Neoplasms, Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColectomyProcedure or surgery
colectomy due to neoplastic (stage 1) or diverticulosis
| Study group | Role | What they receive |
|---|---|---|
| outpatient left laparoscopic colectomy | Left laparoscopic laparoscopic colectomy patient managed on an outpatient basis Receives: Procedure: Colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day readmission rate
Number of re-hospitalisation after a medical-surgical decision due to post-operative complications
Measured: 30 days after surgery
Secondary outcomes (3)
Pain measurement: pain rating scale
Score at the numerical pain rating scale
Measured: 7 days after surgery
Mobilization
Time (in hours) between extubation and first mobilization
Measured: Day 0
Ileus
Number of day between surgery and first gas / stool
Measured: up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start3 Nov 2020
- Primary completion2 Nov 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Alexandre Smirnoff, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310839
- Sponsor's protocol ID
- 2018/P01/280
- Acronym
- COATI
- Status last verified
- Feb 2024
- First submitted
- 13 Mar 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Management of Patients With a Left Laparoscopic Colectomy
- ClinicalTrials.gov ID
- NCT04310839
- Acronym / sponsor ID
- COATI / 2018/P01/280
- Conditions
- Colonic Neoplasms, Colonic Diverticulosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 17 Mar 2020 (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.
The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.
Detailed description
In France, colectomy represents about 40,000 interventions per year, most of them scheduled, and 2/3 in a context of neoplasia. This surgery is associated with numerous postoperative complications. Since the start of Enhanced Recovery After Surgery (ERAS) in 1997, complications have been steadily reduced by optimizing surgical and anaesthetic techniques. At the same time, the average length of post-operative stay has decreased. In 2014, ERAS was the subject of recommendations by the French Society of Anaesthesia and Resuscitation, taken up by the French Health Authority (HAS) in 2016, and which are now an integral part of surgical management in colorectal surgery. More recently, two teams have set up an outpatient colectomy program. The three studies published on this subject show encouraging results, in a private structure, with no increase in postoperative complications.
In accordance with the recommendations on ERAS published by the HAS, a program involving pre-, per- and post-interventional investment, has been put in place. Patients are discharged on D0, followed by close monitoring by a home care nurse twice daily. This nurse is in charge of collecting clinical data in order to detect possible early signs of post-operative complications that would justify re-hospitalisation after a medical-surgical decision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatient left laparoscopic colectomy | – | Procedure: ColectomyLeft laparoscopic laparoscopic colectomy patient managed on an outpatient basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients taken care for a left colectomy due to colonic neoplasm or diverticulosis
Key inclusion criteria (7 listed)
- American Society of Anesthesiologists Classification (ASA) score I and II,
- Patient with an indication for scheduled left colectomy due to neoplastic (stage 1) or diverticulitis,
- Patient residing less than 30 minutes from La Rochelle hospital,
- Presence of a companion from the anaesthesia consultation onwards,
- Presence of an attendant at the patient's discharge,
Key exclusion criteria (12 listed)
- ASA score 3 et 4,
- Indication for a straight or transverse colectomy,
- Neoplasia evolution > stage 1,
- Presence of anticoagulant treatment,
- Intraoperative bleeding > 500ml,
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 |
|---|---|---|
| Colectomycolectomy due to neoplastic (stage 1) or diverticulosis | Procedure or surgery | outpatient left laparoscopic colectomy |
Primary outcome
30-day readmission rate
Time frame: 30 days after surgery
Number of re-hospitalisation after a medical-surgical decision due to post-operative complications
3 secondary outcomes
Pain measurement: pain rating scale
Time frame: 7 days after surgery
Mobilization
Time frame: Day 0
Ileus
Time frame: up to 7 days 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 9 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alexandre Smirnoff, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
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 Colonic Neoplasms and Colonic Diverticulosis, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
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 12 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 9 Feb 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 France. 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?
30-day readmission rate (time frame: 30 days after 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 9 Feb 2024.