Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care (Colon-Ambu)

January 4, 2024 updated by: IHU Strasbourg

Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.

The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors.

While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.

Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.

The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors. Multiple interests have been shown:

  • Equivalent mortality and/or morbidity compared with standard hospitalizations
  • Medical and psychological benefits
  • Individualized and less invasive health care pathways, in favor of patient's autonomy
  • Multidisciplinary approach and innovative care
  • Heath care costs management (decrease of hospital length of stay, optimization of operating rooms).

Ambulatory colectomies feasibility is recognized since 2013-2014 in France (Dr. Gignoux, MD in Lyon and Dr. Chasserant, MD in Le Havre). These ambulatory procedures are implemented in few expert centers with significant experience (more than 100 patients in Le Havre and more than 85 patients in Lyon) but several human and organizational limitations slow this innovative care.

The risk of complications does not seem to be increased on condition of anticipate and provide a postoperative follow-up at home.

While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.

Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female over 18 years old
  • Patient able to understand the objectives and risks related to the trial
  • Patient able to give written informed consent
  • Patient able to understand and accept the health care program
  • Isolated colonic lesion located on the colon or the upper rectum
  • Any neoplastic or non-neoplastic colonic pathology
  • Colonic surgery except resection without continuity interruption (e.g. low cecum resection, partial colectomy, suture for polyp)
  • Moderate and/or controlled comorbidities
  • No history of multiple laparotomies
  • No psychosocial distress
  • No living alone patient
  • Patient registered with the French social security

Exclusion Criteria:

  • Patient in exclusion period of another clinical study
  • Emergency surgical procedure
  • Type 1 diabetes
  • Presence of an uncontrolled preoperative anemia
  • Effective anticoagulation treatment, impossible to suspend
  • Kidney failure (treated by dialysis)
  • Hepatic cirrhosis
  • Patient refusal
  • Patient in custody
  • Patient under guardianship
  • Pregnancy
  • Breastfeeding
  • Poor general condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ambulatory care
Colorectal surgery in ambulatory care
Other: Clinical and economical evaluation
Evaluation of the clinical and the economical impact of a colorectal surgery
Other: Standard hospitalization
Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching.
Other: Clinical and economical evaluation
Evaluation of the clinical and the economical impact of a colorectal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean cost evaluation
Time Frame: 1 month
Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
Time Frame: 7 and 30 days

The EQ-5D Quality of Life scale consists of :

(i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

(ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state" and "Worst imaginable health state".
7 and 30 days
Mean hospital length of stay
Time Frame: 2 years and 3 months
Mean hospital length of stay for the "standard hospitalization" group
2 years and 3 months
Ambulatory colectomies rate
Time Frame: 2 years and 3 months
Rate of ambulatory colectomies compared to the total number of colectomies performed
2 years and 3 months
Ambulatory care failure rate
Time Frame: 2 years and 3 months
Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery
2 years and 3 months
Duty desk call
Time Frame: 2 years and 3 months
Number of patients who called the duty desk (or for whom the duty desk has been called)
2 years and 3 months
Mean time period required for a postoperative complication care
Time Frame: 2 years and 3 months
Mean time period required for a postoperative complication care
2 years and 3 months
Hospital re-admissions rate
Time Frame: 30 days
Rate of hospital re-admissions related to postoperative complications
30 days
Rate of complications (Morbidity)
Time Frame: 30 days
Rate of complications related or not to surgery
30 days
Rate of death (Mortality)
Time Frame: 30 days
Number of patients who died within the individual participation period
30 days
Complications rate
Time Frame: 30 days
Clinical and economic evaluation of postoperative complications rates difference between "ambulatory care" group and "standard hospitalization" group
30 days
Complications severity classification
Time Frame: 30 days
Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification
30 days
Evaluation of complication severity according to Clavien classification
Time Frame: 2 years and 3 months
Severity of the complications will be evaluated according to the Clavien classification from Grade I "Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions" to Grade V "Death of a patient"
2 years and 3 months
Mean additional hospital length of stay
Time Frame: 2 years and 3 months
Clinical and economic evaluation of hospital length of stay related to complications difference between "ambulatory care" group and "standard hospitalization" group (additional hospitalizations, extension of hospitalization or new hospitalization).
2 years and 3 months
Costs related to postoperative complications
Time Frame: 2 years and 3 months
Costs related to postoperative complications difference between "ambulatory care" group and "standard hospitalization" group
2 years and 3 months
Costs related to the management of postoperative complications
Time Frame: 2 years and 3 months

Overall costs are evaluated by individual costs of:

  • unscheduled consultations,
  • surgical treatment,
  • medicated treatment
  • hospitalisation's duration
2 years and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHU Strasbourg

Investigators

  • Principal Investigator: Didier Mutter, MD, PhD, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2019

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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