Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

Surgery Clinical Trial

Official title:

Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552170
• Other study ID #: DS-2017
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2022
• Source: West China Hospital
• Contact: Ziqiang Wang, PHD
• Phone: +8618980602028
• Email: wangziqiang[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of short-term follow-up	The occurrence of postoperative complications	Within 1 month after surgery
Primary	Readmissions	Readmission within 1 month after surgery	Within 1 month after surgery
Primary	Reoperation	Reoperation within 1 month after surgery	Within 1 month after surgery
Secondary	Hospital stays	Hospital stays	1 day