Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

NCT ID: NCT05552170

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Surgery Fast Recovery Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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day case group

Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation.

day-case surgery

Intervention Type OTHER

Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation.

Interventions

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day-case surgery

Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ziqiang Wang,MD

Colorectal Cancer Center, Department of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ziqiang Wang, PHD

Role: CONTACT

+8618980602028

Yu Shen, MD

Role: CONTACT

+8617606441760

Facility Contacts

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Ziqiang Wang, PHD

Role: primary

+8618980602028

Yu Shen, MD

Role: backup

+8617606441760

Other Identifiers

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DS-2017

Identifier Type: -

Identifier Source: org_study_id

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