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Completed

NCT Number: NCT04310839

Outpatient 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colectomy

Procedure

colectomy due to neoplastic (stage 1) or diverticulosis

Primary outcomes

  1. 30-day readmission rate

    Time frame: 30 days after surgery

    Number of re-hospitalisation after a medical-surgical decision due to post-operative complications

Secondary outcomes

  1. Pain measurement: pain rating scale

    Time frame: 7 days after surgery

    Score at the numerical pain rating scale

  2. Mobilization

    Time frame: Day 0

    Time (in hours) between extubation and first mobilization

  3. Ileus

    Time frame: up to 7 days after surgery

    Number of day between surgery and first gas / stool

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • Medtronic

Registry information

Official study title

Outpatient Management of Patients With a Left Laparoscopic Colectomy

Acronym: COATI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2020
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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