Outpatient Left Laparoscopic Colectomy

Colonic Neoplasms Clinical Trial

— COATI  

Official title:

Outpatient Management of Patients With a Left Laparoscopic Colectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310839
• Other study ID #: 2018/P01/280
• Status: Completed
• Start date: November 3, 2020
• Est. completion date: December 2, 2022

Study information

• Verified date: February 2024
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Diverticulosis
• Colonic Neoplasms
• Diverticulosis, Colonic
• Diverticulum

Intervention

Procedure:
• Colectomy
colectomy due to neoplastic (stage 1) or diverticulosis

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis	Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day readmission rate	Number of re-hospitalisation after a medical-surgical decision due to post-operative complications	30 days after surgery
Secondary	Pain measurement: pain rating scale	Score at the numerical pain rating scale	7 days after surgery
Secondary	Mobilization	Time (in hours) between extubation and first mobilization	Day 0
Secondary	Ileus	Number of day between surgery and first gas / stool	up to 7 days after surgery