Clinical trials: PROMs
Surgical Site Infection (SSI), Wound Healing Complication
Prophylactic Use of ciNPWT in Gynecologic Laparotomy
This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure…
- Conditions
- Surgical Site Infection (SSI), Wound Healing Complication, Seroma, Hematoma
- Trial name
- NCT07645547
- Testing
- closed incision negative pressure wound therapy (ciNPWT)
- Volunteers
- 30 people
- Sponsor
- University Hospital Hradec Kralove
Pancreas Disease, Complication,Postoperative
Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)
Main indications for distal pancreatectomy (DP) are pancreatic body and tail tumors including ductal adenocarcinoma, neuroendocrine tumors, and cystic neoplasms.
- Conditions
- Pancreas Disease, Complication,Postoperative, PROMs, Pancreatic Fistula
- Trial name
- Early-Dist (NCT04609137)
- Testing
- Early drain removal, Standard drain removal
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- IRCCS San Raffaele
Gallstones
EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach
Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof…
- Trial name
- NCT01709877
- Testing
- Cholecystectomy
- Where
- 4 sites in Italy
- Volunteers
- 300 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Colorectal Cancer
CITRuS Stage 1; Feasibility
Bowel cancer is the third most common cancer occurring in the UK. Treatment usually involves surgery, often with chemotherapy or radiotherapy.
- Trial name
- CITRuS1 (NCT04697394)
- Where
- United Kingdom
- Volunteers
- 380 people
- Sponsor
- Royal Surrey County Hospital NHS Foundation Trust
Colorectal Cancer
FOcUs on Colorectal CAncer oUtcomes: Long-Term Study
Colorectal cancer (CRC) affects men and women of all racial and ethnic groups and accounts for more than 600,000 deaths per year, globally.
- Trial name
- Foucault (NCT03965325)
- Testing
- Use of a standardized set to collect clinical and patient-centered data, to assess the trend of the Global Health Status overtime in colorectal cancer patients
- Where
- France
- Volunteers
- 133 people
- Sponsor
- IHU Strasbourg
Postoperative Recovery, Quality of Recovery From Anaesthesia
Validation of the Greek Postoperative Quality of Recovery Score 15
The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.
- Conditions
- Postoperative Recovery, Quality of Recovery From Anaesthesia, PROMs, Validation Study
- Trial name
- (QoR-15Gr) (NCT06699823)
- Testing
- Greek version of QoR-15
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- IASO Thessalias
Perioperatoire Medicine, Surgery
Evaluation of a Structured Hospital-Community Care Follow-up Based on Perceived Quality of Care After Surgery, Aimed at Reducing Persistent Opioid Use in Primary Care: a Pragmatic Randomized Controlled Trial
The OPTIMISTE program is based on a structured postoperative follow-up centered on patients' subjective perception of recovery using validated Patient Reported Outcome Measures (PROMs), including the mQoR-15f score.
- Trial name
- OPIOID CITY FR (NCT07659730)
- Testing
- Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus)
- Volunteers
- 772 people
- Sponsor
- University Hospital, Strasbourg, France
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the…
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life
- Trial name
- STOPGSMP (NCT06962345)
- Testing
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Mucosa Innovations, S.L.
Overactive Bladder (OAB), Overactive Bladder Syndrome
Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life
The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and…
- Trial name
- REVEAL-OAB (NCT07545148)
- Volunteers
- 2,000 people
- Sponsor
- European Association of Urology Research Foundation
Bariatric Surgery, Metabolic Surgery
Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs
This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients.
- Conditions
- Bariatric Surgery, Metabolic Surgery, Weight Reduction
- Trial name
- MBSAQIP-PROM (NCT02749305)
- Testing
- Collection of patient-reported outcome measures
- Where
- United States
- Volunteers
- 11,146 people
- Sponsor
- Massachusetts General Hospital
Approach-Approach Conflict, Knee Discomfort
Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics
Two methods for detecting outcomes after knee prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (Oxford Knee Score) VS detection using digital questionnaires…
- Trial name
- DIG-PROMs-k (NCT04752761)
- Testing
- Extrambulatory digital PROMs detection
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Ortopedico Rizzoli
Deep Caries, Indirect Pulp Capping
Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Teeth
Compare the clinical performance and patient satisfaction of Egyptian MTA, Biodentine versus Calcium Hydroxide as indirect pulp capping materials in permanent teeth
- Conditions
- Deep Caries, Indirect Pulp Capping, Mineral Trioxide Aggregate (MTA), Calcium Hydroxide
- Trial name
- NCT06683833
- Testing
- Egyptian MTA, Biodentine, Calcium Hydroxide (Ca(OH)2)
- Where
- Egypt
- Volunteers
- 35 people
- Sponsor
- Cairo University
Heart Failure
PROMs From GEstIC Heart Failure Patients
Heart failure (HF) is a chronic condition with substantial morbidity, and understanding its effects on patients' quality of life is essential.
- Trial name
- PROFIC-HF (NCT06938698)
- Testing
- PROM collection
- Where
- Portugal
- Volunteers
- 155 people
- Sponsor
- Centro Hospitalar do Porto
Acetabular Labrum Tear, Femoro Acetabular Impingement
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively.
- Conditions
- Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy, Physical Therapy
- Trial name
- NCT03909178
- Testing
- Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group), Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Massachusetts General Hospital
Cerebral Palsy
Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy
Children with severe cerebral palsy (CP) are at high risk for progressive hip displacement, associated with pain and contractures interfering with many aspects of care, comfort and quality of life.
- Trial name
- CHOP II (NCT04792606)
- Where
- Canada
- Volunteers
- 1,000 people
- Sponsor
- The Hospital for Sick Children
Endometriosis
Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis
Endometriosis is a chronic disease that affects one out of 10 women. Endometriosis care is full of variation. Recommendations for optimal management vary between clinician and centers.
- Trial name
- NCT04820582
- Testing
- Delphi Questionnaire
- Where
- France
- Volunteers
- 56 people
- Sponsor
- One Clinic