Outpatient Left Laparoscopic Colectomy (COATI)

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.

Study Overview

• Status: Completed
• Conditions: Colonic Neoplasms; Colonic Diverticulosis
• Intervention / Treatment: Procedure: Colectomy

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

• Study Contact: Name: Caroline Allix-Béguec, PhD; Phone Number: +33516494246; Email: caroline.allix-beguec@ght-atlantique17.fr

Study Locations

• France
  • La Rochelle, France
    • Groupe Hospitalier de la Rochelle Ré Aunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients taken care for a left colectomy due to colonic neoplasm or diverticulosis

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
outpatient left laparoscopic colectomy; Left laparoscopic laparoscopic colectomy patient managed on an outpatient basis	Procedure: Colectomy; colectomy due to neoplastic (stage 1) or diverticulosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day readmission rate	Number of re-hospitalisation after a medical-surgical decision due to post-operative complications	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measurement: pain rating scale	Score at the numerical pain rating scale	7 days after surgery
Mobilization	Time (in hours) between extubation and first mobilization	Day 0
Ileus	Number of day between surgery and first gas / stool	up to 7 days after surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Collaborators: Medtronic
• Investigators: Study Director: Alexandre Smirnoff, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic
• Other Study ID Numbers: 2018/P01/280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No