Clinical trial NCT04310839: Outpatient Left Laparoscopic Colectomy
Official title: Outpatient Management of Patients With a Left Laparoscopic Colectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Neoplasms
Colonic Diverticulosis
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taken care for a left colectomy due to colonic neoplasm or diverticulosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30-day readmission rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Pain measurement: pain rating scale
timeFrame: 7 days after surgery
measure: Mobilization
timeFrame: Day 0
measure: Ileus
timeFrame: up to 7 days after surgery
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Alexandre Smirnoff, MD
role: STUDY_DIRECTOR
References: