Crohn Disease Clinical Trial
Official title:
Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
Verified date | December 2017 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients who are willing to give consent and comply with the evaluation and the treatment schedule - Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon - American Society of Anesthesiologists (ASA) =< 3 Exclusion Criteria: - Inability to obtain informed consent - Previous right colon surgery - Previous extensive abdominal surgery that would limit the laparoscopic approach - Stage IV disease at surgery - Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging - Patient enrolled in other interventional study - ASA score greater than 3 - Any condition which precludes compliance with the study (Investigator discretion) - Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative time | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year | |
Primary | Length of skin and fascial incisions | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year | |
Primary | Estimated blood loss | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year | |
Primary | Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year | |
Secondary | Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | Baseline | |
Secondary | Quality of life measured using the SF-12 HQRL scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 2 weeks | |
Secondary | Quality of life measured using the SF-12 HQRL scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 3 months | |
Secondary | Quality of life measured using the SF-12 HQRL scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 6 months | |
Secondary | Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | Baseline | |
Secondary | Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 2 weeks | |
Secondary | Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 3 months | |
Secondary | Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 6 months | |
Secondary | Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 2 weeks | |
Secondary | Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 3 months | |
Secondary | Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
Recruiting |
NCT05169593 -
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
|
Phase 4 | |
Recruiting |
NCT06116604 -
Early Bowel Resection for Terminal Ileal Crohn's Disease
|
||
Recruiting |
NCT05294107 -
Intestinal Organoids
|
N/A | |
Recruiting |
NCT05627128 -
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
|
N/A | |
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Withdrawn |
NCT04349449 -
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
|
||
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Completed |
NCT03058679 -
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
|
N/A | |
Completed |
NCT02871635 -
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
|
Phase 3 | |
Recruiting |
NCT04266600 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|
N/A | |
Recruiting |
NCT04539665 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
|
N/A | |
Recruiting |
NCT03913572 -
Treatment of Perianal Disease Using Adipose-derived Stem Cells
|
||
Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
Terminated |
NCT04102111 -
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
|
Phase 2 | |
Recruiting |
NCT04997733 -
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
|
Phase 3 | |
Recruiting |
NCT05906576 -
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
|
Phase 4 | |
Not yet recruiting |
NCT04502303 -
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
|
Phase 2 | |
Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 |