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Outpatient Left Laparoscopic Colectomy

Outpatient Management of Patients With a Left Laparoscopic Colectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04310839
Acronym
COATI
Enrollment
30
Registered
2020-03-17
Start date
2020-11-03
Completion date
2022-12-02
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diverticulosis, Colonic Neoplasms

Brief 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. 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.

Interventions

PROCEDUREColectomy

colectomy due to neoplastic (stage 1) or diverticulosis

Sponsors

Medtronic
CollaboratorINDUSTRY
Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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, * 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.

Design outcomes

Primary

MeasureTime frameDescription
30-day readmission rate30 days after surgeryNumber of re-hospitalisation after a medical-surgical decision due to post-operative complications

Secondary

MeasureTime frameDescription
MobilizationDay 0Time (in hours) between extubation and first mobilization
Ileusup to 7 days after surgeryNumber of day between surgery and first gas / stool
Pain measurement: pain rating scale7 days after surgeryScore at the numerical pain rating scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026