Polyp of Colon Clinical Trial
Official title:
A Prospective, Non-randomized Multicenter Study Verifying C-REX LapAid and C-REX DMH/DMHC
Verified date | January 2018 |
Source | Carponovum AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In colorectal surgery, hand suturing and stapling are routine methods for performing
intestinal anastomoses, and these methods appear to be similar in terms of clinical safety.
Despite several years of experience with surgical procedures as well as improvements to the
medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis
after colorectal surgery remain a significant challenge for surgeons. In addition,
preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even
further.
The methods that are used today to detect leakages are unfortunately inaccurately and limited
to monitoring symptoms, temperature, CRP (C-reactive protein)-levels, and performing
abdominal examinations and CT-scans. These clinical signs and parameters usually become
apparent several days after onset of the leakage, which leads to a delayed diagnosis.
Anastomotic leakage is not only a significant cause of increased morbidity of complications
and mortality in patients, but also associated with increased risk of local recurrence and
poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma
may be made at the level of the sigmoid colon and this procedure impacts quality of life
negatively.
Based on the above considerations, a novel, adaptive anastomotic method has been developed by
CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking
Procedure (C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal
ends and validate the anastomosis, with function of Extract samples for analysis and conduct
X-ray through connected catheters).
The novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to
use, with unique possibility to control the anastomosis during and after surgery. The
previous successful preclinical study encourages a clinical verification in patients
undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking
Procedure by use of C-REX LapAid and C-REX DMH/DMHC.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 10, 2017 |
Est. primary completion date | June 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Male or female age = 18 years and = 70 years. 2. Planned resection due to benign or malign disease in the left colon (descending colon and sigmoid) or the upper rectum (15 cm above the anal rim). 3. Cognitive ability to take part in the study and understand the information he/she receives about participating in the study. 4. Sign the informed consent form. Exclusion Criteria: 1. Urgent medical condition requiring immediate care. 2. Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or dissemination (metastases) of cancer. 3. Stenosis or other obstructions in the anal passage. 4. Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis. 5. Health condition classified as ASA (American Society of Anesthesiologists) score III - VI. 6. Albumin level less than 35 g/l. 7. Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease). 8. Disease that requires more than one anastomosis during the surgical procedure. 9. Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery. 10. Contraindications to general anesthesia. 11. Perioperative detection of extreme variants of intestinal diameters or wall thickness. 12. Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study. 13. BMI > 35. 14. Heart attack = 6 months or sever heart disease. 15. Severe embolic disease. 16. Other conditions which surgeons think the patient should be excluded. - |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
Carponovum AB | The First Affiliated Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hemoglobin | Blood tests to detect potential anastomotic leakage. | Up to 30 days after surgery, when needed | |
Other | WBC (white blood cell) | Blood tests to detect potential anastomotic leakage. | Up to 30 days after surgery, when needed | |
Other | Physical examination | Body temperature, palpation of abdomen etc. | Up to 30 days after surgery | |
Other | Procedures and/or device related adverse events | The clinical investigator notes the adverse events, severity and the relation to the investigational device. | Up to 30 days after surgery | |
Primary | Time to evacuation of the short-term implant | The subject informs the clinical investigator and hand over the expelled short-term implant | About 2 weeks after surgery | |
Secondary | Time to first intestinal sounds | The subject informs the clinical investigator about when the intestine begin to murmur, and the clinical investigator will check the sound with a stethoscope. | Up to 30 days after surgery | |
Secondary | Time to first passage of gas | The subject informs the clinical investigator when it occurs. | Up to 30 days after surgery | |
Secondary | Time to first defecation | The subject informs the clinical investigator when it occurs. | Up to 30 days after surgery | |
Secondary | Number of postoperative interventions related to the device | The clinical investigator notes the interventions after surgery related to the use of device, for instance, CT scan, endoscopy examination and re-operation etc. | Up to 30 days after surgery | |
Secondary | Integrity pressure | To confirm that the two anastomotic rings are properly locked to each other, measure integrity pressure through catheters connected to DMC (if DMC is applied). By infusing air into the closed space adjacent to the anastomosis via on catheter and concomitantly camping the other three catheters. When the pressure in the closed space exceeds the contact-induced closure by the joined intestinal segments, the pressure abruptly dropped and is defined as integrity pressure. | The operation day | |
Secondary | Post-operative X-ray examination | The anastomosis could be examined through catheters connected to DMC (if DMC is applied) in case of suspect of anastomotic leakage. The integrity of anastomosis is examined by local infusion of water-soluble contract media through one of the catheters, and at the same time conduct X-ray examination. The contract media will leak from the closed space adjacent to the anastomosis if there is a anastomotic leakage. | Up to 4 days after surgery | |
Secondary | Time of surgery | The time to complete the operation. | The operation day |
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