Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

NCT ID: NCT03760939

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2024-11-15

Brief Summary

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.

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.

Conditions

Colorectal Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Ambulatory care

Colorectal surgery in ambulatory care

Group Type: EXPERIMENTAL

Clinical and economical evaluation

Intervention Type: OTHER

Evaluation of the clinical and the economical impact of a colorectal surgery

Standard hospitalization

Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching.

Group Type: OTHER

Clinical and economical evaluation

Intervention Type: OTHER

Evaluation of the clinical and the economical impact of a colorectal surgery

Interventions

Clinical and economical evaluation

Evaluation of the clinical and the economical impact of a colorectal surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Mutter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Locations

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, , France

Countries

France

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Other Identifiers

18-001

Identifier Type: -

Identifier Source: org_study_id