Evaluating the impact of different surgical techniques on quality of life after esophageal reconstruction
Official title: Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)
Run by Hospital Universitari de Bellvitge · NCT05802459 · Data updated 2026-11-12
This study is testing how different surgical methods for esophageal reconstruction affect the quality of life for patients after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | December 15, 2022 |
| Main results expected | September 2025 |
| Study ends | September 2027 |
| Registry record updated | April 6, 2023 |
| Trial ID | NCT05802459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients aged 18 and older who are undergoing complete esophageal reconstruction and are eligible for either coloplasty or jejunoplasty.
✕Probably not a fit
Patients who are not candidates for esophageal reconstruction or who withdraw consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the functional status and quality of life in patients undergoing complex esophageal reconstruction using different types of conduits, specifically coloplasty and jejunoplasty. Participants will complete various quality of life questionnaires and undergo additional tests during follow-up visits to evaluate their functionality. The study seeks to clarify the impact of these surgical techniques on patient outcomes, addressing the ongoing debate regarding the best conduit choice when the stomach is not viable.
Why it matters
Potential benefit: If successful, this study could provide insights that improve surgical decision-making and enhance the quality of life for patients undergoing esophageal reconstruction.
How similar studies have gone: While there is ongoing debate regarding the best surgical techniques for esophageal reconstruction, this study aims to provide new insights, suggesting that it may be exploring a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 years of age) and of both gender. * Candidates for complete esophageal reconstruction with cervical anastomosis, regardless of the etiology of the esophagectomy. * Decision to indicate a coloplasty (+/- supercharged) or jejunoplasty (free, pedunculated +/- supercharged) as surgical technique after evaluation by the UREC Committee. * Acceptance to participate in the study and comply with the program of procedures (schedule of visits). * Signing of the informed consent. Exclusion Criteria: * Patients who withdraw their informed consent at any time during the course of the study.
Where it's running
-
Hospital Uversitari de Bellvitge
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Monica Miró
- Email: mmiro@bellvitgehospital.cat
- Phone: +34932607500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.