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Procedure
Minimally Invasive Colon Surgery for Post-Surgery Recovery (TVC Trial)
N/A
Waitlist Available
Led By Jaime Sanchez, MD
Research Sponsored by Jaime Sanchez
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with one of the following benign or malignant conditions for which they require colonic resection with a specimen that may be removed transvaginally if randomized to that group: Adenomatous polyposis, Chronic GI bleeding, Chronic obstruction, Colon cancer, Colonic inertia, Diverticular disease, Rectal cancer, Colorectal Polyps, Rectal prolapse, Slow transit constipation / colonic inertia
Require one of the following elective operations that may be safely performed by current laparoscopic-assisted techniques: Right hemicolectomy, Left hemicolectomy, Subtotal colectomy, Total abdominal colectomy, Sigmoid colectomy, Rectosigmoid resection, Low anterior resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 1 through 1 year
Awards & highlights
TVC Trial Summary
This trial will test a new, minimally invasive technique for colon surgery in women, which may lead to fewer infections and a shorter hospital stay.
Who is the study for?
This trial is for adult women needing certain elective colon surgeries, like colectomies or resections. They must be over 18, able to follow the study plan and consent to it. Excluded are those with inflammatory bowel disease, pelvic radiation history, severe kidney issues, pregnancy or plans to become pregnant soon after surgery, high surgical risks due to anatomy or bulky tumors, very poor health status (ASA classes 4 and 5), vaginal stenosis, a BMI over 35, or prior reconstructive vaginal surgery.Check my eligibility
What is being tested?
The study tests a laparoscopic-assisted transvaginal technique called LANOS for removing parts of the colon in women. It aims to see if this method reduces postoperative infections and improves recovery compared to traditional methods that require abdominal incisions.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site where instruments enter through the vagina and abdomen complications such as infection risk at these sites. There might also be general risks associated with anesthesia and laparoscopic procedures.
TVC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a colon condition like cancer, polyps, or chronic bleeding.
Select...
I need a specific type of colon surgery that can be done with minimal incisions.
TVC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 1 through 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 1 through 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Post-operative Infections
Secondary outcome measures
Post-operative Pain
TVC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transvaginal Laparoscopic-Assisted ColectomyExperimental Treatment1 Intervention
Laparoscopic-Assisted Natural Orifice Surgery
Group II: Traditional Laparoscopic-Assisted ColectomyActive Control1 Intervention
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Who is running the clinical trial?
Jaime SanchezLead Sponsor
Jaime Sanchez, MDPrincipal InvestigatorUniversity of South Florida
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had reconstructive surgery on my vagina, but not a hysterectomy.I need surgery urgently.I am a woman aged 18 or older.My kidney function is severely reduced.I have had radiation treatment to my pelvic area.I might need an ostomy during my surgery.I am willing and able to sign the consent form for this study.I need surgery for a colon condition like cancer, polyps, or chronic bleeding.I need a specific type of colon surgery that can be done with minimal incisions.I am willing and able to follow the study's requirements.My doctor thinks traditional surgery is too risky for me due to my condition.I have or might have an inflammatory bowel disease like Crohn's or ulcerative colitis.I have narrowing or tightening of my vagina.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional Laparoscopic-Assisted Colectomy
- Group 2: Transvaginal Laparoscopic-Assisted Colectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities for participants to enroll in this research?
"Clinicaltrials.gov indicates that this research project is not actively recruiting participants at the present moment, having been initially posted on August 1st 2013 and last edited October 27th 2017. However, there are one or more other medical studies looking for patients now."
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