SurgeryNCT05552170
Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal
An observational study of Surgery and Fast Recovery Surgery, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgery, Fast Recovery Surgery
- What is being tested?
- day-case surgery
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All potential patients preparing for LIR were asked to undergo multiple evaluations at our outpatient department by gastrointestinal surgeons and anesthetists together. They were admitted to our ambulatory surgery center and included in the CHJ-ERAS program for ALIR if none of the exclusion criteria was met.
Who may be able to join
- Patients with ileostoma and preparing for LIR
- Patients age between 18-65;
- ASA grade II;
- Patients willing to underwent day-case LIR
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 640001
Ziqiang Wang, PHD, +8618980602028, wangziqiang@scu.edu.cn
Yu Shen, MD, +8617606441760, hi_moke@163.com
About this study
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.
Read the 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.
- Conditions
- Surgery, Fast Recovery Surgery
- Being tested
- day-case surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
day-case surgeryOther
Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation.
| Study group | Role | What they receive |
|---|---|---|
| day case group | Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation. Receives: Other: day-case surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of short-term follow-up
The occurrence of postoperative complications
Measured: Within 1 month after surgery
Readmissions
Readmission within 1 month after surgery
Measured: Within 1 month after surgery
Reoperation
Reoperation within 1 month after surgery
Measured: Within 1 month after surgery
Secondary outcomes (1)
Hospital stays
Hospital stays
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Aug 2017
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552170
- Sponsor's protocol ID
- DS-2017
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal
- ClinicalTrials.gov ID
- NCT05552170
- Acronym / sponsor ID
- DS-2017
- Conditions
- Surgery, Fast Recovery Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| day case group | – | Other: day-case surgeryPatients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All potential patients preparing for LIR were asked to undergo multiple evaluations at our outpatient department by gastrointestinal surgeons and anesthetists together. They were admitted to our ambulatory surgery center and included in the CHJ-ERAS program for ALIR if none of the exclusion criteria was met.
Key inclusion criteria (4 listed)
- Patients with ileostoma and preparing for LIR
- Patients age between 18-65;
- ASA grade II;
- Patients willing to underwent day-case LIR
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| day-case surgeryPatients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation. | Other | day case group |
Primary outcome
Results of short-term follow-up
Time frame: Within 1 month after surgery
The occurrence of postoperative complications
Readmissions
Time frame: Within 1 month after surgery
Readmission within 1 month after surgery
Reoperation
Time frame: Within 1 month after surgery
Reoperation within 1 month after surgery
1 secondary outcome
Hospital stays
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Fast Recovery Surgery, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziqiang Wang, PHD (+8618980602028, wangziqiang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of short-term follow-up (time frame: Within 1 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.