Postoperative Complications Clinical Trial
Official title:
Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate. The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 years and 80 years old 2. Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia 3. Willingness to participate 4. Compliance to study purpose 5. Written informed consent Exclusion Criteria: 1. Need for an anastomosis below the anterior peritoneal reflection 2. Need for a major resection other than colorectal 3. Need for post-operative intensive care monitoring or intensive care unit (ICU) stay 4. Anesthesia time longer than 300 minutes 5. Presence of chronic indwelling UC 6. Presence of an entero-vesical fistula 7. Need for ureteral stent placement, bladder resection or repair 8. A previous and unsolved history of AUR or overt voiding dysfunction |
Country | Name | City | State |
---|---|---|---|
Italy | Division of General and Hepatobiliary Surgery | Verona |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona | Faenza Hospital, Humanitas University, IRCCS Humanitas Research Hospital, Ravenna Hospital, Universita di Verona |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute urinary retention rate | Occurrence of urinary retention after removal of urinary catheter | 3 days postoperatively | |
Secondary | Urinary tract infections | Occurrence of urinary tract infections | 30 days postoperatively | |
Secondary | UC reinsertion | need for urinary catheter reinsertion after first removal | 30 days postoperatively | |
Secondary | Pain scores | Numeric Rating Scores (NRS) for abdominal pain (0-10) | 6,12,24,48 and 72 hours after surgery | |
Secondary | Bowel function | Time for return of bowel function as for flatus and stools postoperatively | 10 days postoperatively | |
Secondary | Mobilization | Return to passive and active mobilization postoperatively | 10 days postoperatively | |
Secondary | Morbility | Postoperative morbility according to the Clavien-Dindo classification | first 30 days after surgery | |
Secondary | Length of hospital stay | postoperative stay | 30 days postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03181620 -
Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation
|
N/A | |
Recruiting |
NCT04205058 -
Coffee After Pancreatic Surgery
|
N/A | |
Completed |
NCT06425601 -
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
|
N/A | |
Completed |
NCT02565420 -
Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial
|
N/A | |
Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
Completed |
NCT03662672 -
Rib Raising for Post-operative Ileus
|
N/A | |
Completed |
NCT03787849 -
Epigenetics in PostOperative Pediatric Emergence Delirium
|
N/A | |
Active, not recruiting |
NCT05886387 -
a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
|
||
Not yet recruiting |
NCT06351475 -
Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
|
N/A | |
Not yet recruiting |
NCT05052021 -
The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
|
||
Not yet recruiting |
NCT03591432 -
A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
|
N/A | |
Not yet recruiting |
NCT03639012 -
Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
|
N/A | |
Not yet recruiting |
NCT03275324 -
Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients
|
N/A | |
Recruiting |
NCT02763878 -
Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
|
Phase 3 | |
Completed |
NCT02947789 -
Predictive Model for Postoperative Mortality
|
N/A | |
Completed |
NCT02891187 -
Visits Versus Telephone Calls for Postoperative Care
|
N/A | |
Not yet recruiting |
NCT02542423 -
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
|
N/A | |
Completed |
NCT02766062 -
Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome
|
N/A | |
Recruiting |
NCT01934049 -
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
|
Phase 4 | |
Enrolling by invitation |
NCT01744938 -
Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice
|
Phase 3 |