Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04310839
Other study ID # 2018/P01/280
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT06041945 - Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology N/A
Not yet recruiting NCT02688699 - Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract Phase 4
Not yet recruiting NCT03175146 - A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely N/A
Completed NCT02529007 - Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening N/A
Not yet recruiting NCT01929499 - Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer Phase 2
Completed NCT01681472 - PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer Phase 1/Phase 2
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Terminated NCT00267787 - Molecular Genetic and Pathological Studies of Anal Tumors
Completed NCT05498051 - Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW. N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03314896 - Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial) N/A
Not yet recruiting NCT02777437 - Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer Phase 2/Phase 3
Not yet recruiting NCT02852915 - Laparoscopic Surgery for T4 Tumor of the Colon Cancer Phase 3
Completed NCT00997802 - Japanese National Computed Tomographic (CT) Colonography Trial N/A
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT00470782 - Aerobic Capacity and Body Composition in Colon Cancer Patients N/A
Completed NCT00537901 - First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study N/A