Outpatient Left Laparoscopic Colectomy

NCT04310839 | Completed

• 1 other identifier: 2018/P01/280
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms; Colonic Diverticulosis

Outcome Measures

Primary Outcomes (1)

• 30-day readmission rate

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

  30 days after surgery

Secondary Outcomes (3)

• Pain measurement: pain rating scale

  7 days after surgery

• Mobilization

  Day 0

• Ileus

  up to 7 days after surgery

Study Arms (1)

outpatient left laparoscopic colectomy

Left laparoscopic laparoscopic colectomy patient managed on an outpatient basis

Procedure: Colectomy

Interventions

Colectomy PROCEDURE

colectomy due to neoplastic (stage 1) or diverticulosis

outpatient left laparoscopic colectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead
• Medtronic: collaborator

Study Sites (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location

MeSH Terms

Conditions

Colonic Neoplasms; Diverticulosis, Colonic

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Alexandre Smirnoff, MD

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: November 3, 2020
• Primary Completion: November 2, 2022
• Study Completion: December 2, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (1)