Identifying factors that affect quality of life after sigmoid surgery for diverticular disease
PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study
Städtisches Klinikum München GmbH · NCT03527706
This study looks at how different factors affect the quality of life for people recovering from sigmoid surgery for diverticular disease to help improve their treatment and recovery experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Städtisches Klinikum München GmbH (other) |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT03527706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictors that influence postoperative health-related quality of life in patients undergoing elective sigmoidectomy for diverticular disease. It addresses the need for a tailored therapeutic approach by focusing on quality of life measurements before and after surgery. The study will collect data from patients scheduled for the procedure to better understand how various factors impact their recovery and overall well-being. By doing so, it seeks to avoid unnecessary surgeries and improve decision-making in treatment options.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 scheduled for elective sigmoidectomy due to diverticular disease with specific indications.
Not a fit: Patients with acute diverticulitis, advanced malignancies, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative quality of life for patients undergoing sigmoidectomy for diverticular disease.
How similar studies have performed: While there have been studies focusing on quality of life in surgical patients, this specific approach to identifying predictors post-surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients, scheduled for elective sigmoidectomy for diverticular disease (Indication: foregoing acute diverticulitis with pericolic or pelvic abscess \>1cm, ongoing complaints after acute uncomplicated diverticulitis, recurrent uncomplicated disease (three or more diverticulitis episodes in combination with the patients wish for surgery), recurrent complicated disease (three or more diverticulitis episodes+complications: stenosis, fistula, chronic pain), urgent wish of patients for surgery after uncomplicated disease. * Age \>18 years * ASA 1-3 * informed consent Exclusion Criteria: * Age \<18 years * ASA 4 * acute diverticulitis with free perforation * acute or forgoing diverticular bleeding * colorectal malignancies (current or foregoing) * immunosuppression (corticoids \> 20 mg prednisolon/d, status post transplant) * advanced malignancy with systemic metastases
Where this trial is running
Munich, Bavaria
- Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Study coordinator: Maximilian Sohn, Dr. med.
- Email: maximilian.sohn@klinikum-muenchen.de
- Phone: +49-89-9270702756
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.
Conditions: Diverticular Disease of Colon, Quality of Life