Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

Based on enhanced recovery after surgery (ERAS), ambulatory loop ileostomy reversal (ALIR) has been reported in developed countries. However, there is still no research proposing how to carry out ALIR in developing countries. This study was performed to determine the feasibility of ALIR in China based on the community hospital joined enhanced recovery after surgery (CHJ-ERAS) program.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Fast Recovery Surgery
• Intervention / Treatment: Other: day-case surgery

Detailed Description

CHJ-ERAS program for ALIR was launched. Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation. Strict follow-ups were conducted after ALIR. The primary outcome was the results of short-term follow-ups.

• Study Type: Observational
• Enrollment (Anticipated): 216

Contacts and Locations

• Study Contact: Name: Ziqiang Wang, PHD; Phone Number: +8618980602028; Email: wangziqiang@scu.edu.cn
• Study Contact Backup: Name: Yu Shen, MD; Phone Number: +8617606441760; Email: hi_moke@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 640001
      • Recruiting
      • West China Hospital
      • Contact: Ziqiang Wang, PHD; Phone Number: +8618980602028; Email: wangziqiang@scu.edu.cn
      • Contact: Yu Shen, MD; Phone Number: +8617606441760; Email: hi_moke@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All potential patients preparing for LIR were asked to undergo multiple evaluations at our outpatient department by gastrointestinal surgeons and anesthetists together. They were admitted to our ambulatory surgery center and included in the CHJ-ERAS program for ALIR if none of the exclusion criteria was met.

Description

Inclusion Criteria:

1. Patients with ileostoma and preparing for LIR
2. Patients age between 18-65;
3. ASA grade II;
4. Patients willing to underwent day-case LIR

Exclusion Criteria:

• 1) Patients who underwent single-lumen ileostomy, transverse colostomy or Hartmann; 2) Complex previous laparotomies or required exploratory laparotomy; 3) Age over 65; 4) ASA grade over III (assessed by anesthetists); 5) Presence of moderate or severe preoperative anemia (hemoglobin <90g/L); 6) Therapeutic anticoagulation or anti-platelet medications used within 1 week before surgery; 7) Patient refusal; 8) Severe co-morbidities or other conditions evaluated by surgeons or anesthetists not inappropriate to be included in the program.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
day case group; Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation.	Other: day-case surgery; Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of short-term follow-up	The occurrence of postoperative complications	Within 1 month after surgery
Readmissions	Readmission within 1 month after surgery	Within 1 month after surgery
Reoperation	Reoperation within 1 month after surgery	Within 1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stays	Hospital stays	1 day

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): July 31, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DS-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No