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Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

S

Sichuan University

Status

Enrolling

Conditions

Surgery
Fast Recovery Surgery

Treatments

Other: day-case surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05552170
DS-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

216 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

216 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Ziqiang Wang, PHD; Yu Shen, MD

Data sourced from clinicaltrials.gov

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