Rectal Cancer Clinical Trial
Official title:
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer
The aim of this prospective randomized study is to compare early vs. late closer of the
protecting ileostoma in patients requiring rectal resection for rectal cancer.
Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.
Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal
resection with a protecting ileostoma.
A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate
the anastomosis in all patients. The patients will be randomized after the
"intention-to-treat" principle, before the primary operation.
If there is no radiologic signs of contrast leakage ore other contraindications for early
closer as septic episodes ore missing bowl movements the early closure will be preformed.
Primary end point is the rate of either postoperative death or postoperative complications
occurring at 90 days after the rectal resection.
Major and minor postoperative complications (anastomotic leakage, post operative death,
anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related
complications (prolapsus or peristomial eventration, erosive peristomal dermatitis,
dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.
LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months
postoperatively.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06380101 -
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)
|
N/A | |
| Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
| Recruiting |
NCT04323722 -
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
| Active, not recruiting |
NCT01347697 -
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
|
N/A | |
| Recruiting |
NCT04495088 -
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
|
Phase 3 | |
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03520088 -
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
|
N/A | |
| Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
| Recruiting |
NCT04749381 -
The Role of TCM on ERAS of Rectal Cancer Patients
|
Phase 2 | |
| Enrolling by invitation |
NCT05028192 -
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
|
||
| Recruiting |
NCT03283540 -
Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
|
||
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Recruiting |
NCT05914766 -
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
|
N/A | |
| Recruiting |
NCT04852653 -
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
|
||
| Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
| Terminated |
NCT02933944 -
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
|
Phase 1 | |
| Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A |