Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial

NCT03941522 | Unknown

• 1 other identifier: 2019-4382
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.

Conditions

Ileostomy - Stoma

Keywords

loop ileostomy; diversion ileostomy; ileostomy closure

Outcome Measures

Primary Outcomes (1)

• Total length of hospital stay

  The number of days spent in the hospital from the time of the surgery to the time of the discharge as well as any day spent in the hospital after any readmission in the 30 days following the ileostomy closure.

  30 days after surgery

Secondary Outcomes (5)

• Readmission rate

  30 days after surgery

• Postoperative complication rate

  30 days after surgery

• Postoperative ileus rate

  30 days after surgery

• Postoperative surgical site infection rate

  30 days after surgery

• Postoperative mortality rate

  30 days after surgery

Study Arms (2)

Intervention group (23-hour stay)

EXPERIMENTAL

Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.

Other: Early discharge from hospital

Control group (conventional hospitalization)

NO INTERVENTION

Patients randomized to the group conventional hospitalization will be hospitalized as per the current conventional care after ileostomy closure.

Interventions

Early discharge from hospital OTHER

Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.

Intervention group (23-hour stay)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older
• Able to provide informed consent
• ASA I and II (American Society of Anesthesiologists)
• Staying less than 50 kilometers from a hospital after surgery
• Being accompanied by an adult able to assist the patient in his recovery and to intervene in case of an emergency for the first 48 hours after surgery
• No anastomotic leak proven on preoperative water soluble enema

You may not qualify if:

• Language barrier or significant communication problem
• Immunosuppression
• Therapeutic anticoagulation
• Previous proctocolectomy
• Previous ileal pouch anal anastomosis
• Technical factors during surgery (conversion to midline laparotomy or other, at surgeon's discretion)

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (2)

Hôpital Saint-François d'Assise

Québec, Quebec, G1L 3L5, Canada

Location

Hôtel-Dieu de Québec

Québec, G1R 2J6, Canada

Location

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Study Officials

• François Letarte, MD, MSc

  CHU de Québec-Université Laval

  STUDY DIRECTOR

• Xavier Paré, MD

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

• Geneviève Morin, MD

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Paré, MD

CONTACT

418-684-7482; xavier.pare.2@ulaval.ca

Geneviève Morin, MD

CONTACT

418-641-9284; genevieve.morin.27@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: June 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)