Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer. Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel. Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient. Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients age is 18 years or older

• Patients presenting with symptoms of obstruction (including cecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon) caused by (high suspicion or histologically proven) colonic cancer.

• Patient presenting with symptoms of partial obstruction (abdominal pain, nausea, vomiting, diarrhoea) confirmed by the presence of a dilated colon or ileum with a computed tomography (CT-scan).

• Treatment with curative intent.

Locations
Other Locations
Netherlands
Amphia Hospital
RECRUITING
Breda
Contact Information
Primary
Elze Lockhorst, Drs.
elockhorst@amphia.nl
+31613723827
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 110
Treatments
Nasogastric tube
Patients with right sided obstructive colon cancer will receive non-surgical decompression with a nasogastric probe. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will have their resection 7-10 days after initial decompression.
Ileostomy
Patients with right sided obstructive colon cancer will receive a ileostomy. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.
Right-sided stent
Patients with right sided obstructive colon cancer will receive a right-sided stent. Prior to the definitive oncological resection, patients undergo preoperative optimisation which involves the engagement of a dietician and physiotherapist. Patients eligible for elective resection will be operated at least 7 days after initial decompression and no later than 4 weeks after initial presentation.
Related Therapeutic Areas
Sponsors
Leads: Amphia Hospital

This content was sourced from clinicaltrials.gov