Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

Recruiting

• Conditions: Fast Recovery Surgery; Surgery
• Interventions: Other: day-case surgery

• Registration Number: NCT05552170
• Lead Sponsor: West China Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2017-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reoperation	Within 1 month after surgery	Reoperation within 1 month after surgery
Results of short-term follow-up	Within 1 month after surgery	The occurrence of postoperative complications
Readmissions	Within 1 month after surgery	Readmission within 1 month after surgery

Secondary Outcome Measures

Name	Time	Method
Hospital stays	1 day	Hospital stays

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China