Evaluating outcomes of loop ileostomy reversal in a community hospital setting
Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal
This study is testing if a new, same-day surgery to reverse loop ileostomy can be safely done in a community hospital in China for adults aged 18 to 65.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05552170 on ClinicalTrials.gov |
What this trial studies
This study assesses the feasibility of ambulatory loop ileostomy reversal (ALIR) in a developing country, specifically China, through the community hospital joined enhanced recovery after surgery (CHJ-ERAS) program. Patients aged 18-65 with ASA grades II or III who have undergone loop ileostomy will be enrolled and monitored closely after the procedure. The primary focus is on short-term outcomes following the day-case surgery approach. This observational study aims to provide insights into the effectiveness of ALIR in a community hospital context.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-65 with an ileostoma preparing for loop ileostomy reversal and classified as ASA grade II or III.
Not a fit: Patients over 65, those with severe co-morbidities, or those who have undergone complex previous surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery times and improve surgical outcomes for patients undergoing ileostomy reversal.
How similar studies have performed: While there is limited research on ALIR in developing countries, enhanced recovery after surgery protocols have shown success in similar contexts in developed nations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chengdu, Sichuan
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Ziqiang Wang, PHD
- Email: wangziqiang@scu.edu.cn
- Phone: +8618980602028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.