Evaluating the impact of different surgical techniques on quality of life after esophageal reconstruction
Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)
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 |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05802459 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not candidates for esophageal reconstruction or who withdraw consent will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Barcelona
- Hospital Uversitari de Bellvitge — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Monica Miró
- Email: mmiro@bellvitgehospital.cat
- Phone: +34932607500
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.