Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Traditional Laparoscopic-Assisted Colectomy
No interventions assigned to this group
Transvaginal Laparoscopic-Assisted Colectomy
Laparoscopic-Assisted Natural Orifice Surgery
Laparoscopic-Assisted Natural Orifice Surgery
Surgical procedure performed using an operating endoscope that is introduced into the body through a natural orifice and is then passed into the peritoneal cavity through the lumen of an organ such as the stomach, bowel or vagina.
Interventions
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Laparoscopic-Assisted Natural Orifice Surgery
Surgical procedure performed using an operating endoscope that is introduced into the body through a natural orifice and is then passed into the peritoneal cavity through the lumen of an organ such as the stomach, bowel or vagina.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. Willingness and ability to comply with the requirements of the study protocol including follow-up
5. Willingness and ability to sign the study specific informed consent
Exclusion Criteria
2. Any anatomical consideration that in the Investigator's opinion would make the traditional laparoscopic or transvaginal approach to resection excessively risky or impossible. Patients with bulky tumors that would require open operations are not candidates for this study.
3. Body Mass Index (BMI) \> 35
4. Vaginal stenosis
5. Prior reconstructive surgery of the vagina not including hysterectomy
6. ASA classes 4 and 5
7. Advanced renal insufficiency (estimated creatinine clearance ≤30 mL/min/1.73 m2)
8. Any history of pelvic radiation
9. Anticipated need for an ostomy at the time of operation
10. Patients requiring urgent or emergent surgery
11. Patients with prior or suspected diagnosis of inflammatory bowel disease such as Crohns disease or ulcerative colitis.
18 Years
ALL
No
Sponsors
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Jaime Sanchez
OTHER
Responsible Party
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Jaime Sanchez
Assistant Professor of Surgery
Principal Investigators
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Jaime Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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Tampa General Hospital
Tampa, Florida, United States
Countries
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Facility Contacts
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Rachel Karlnoski, PhD
Role: primary
Thanh Tran, MS
Role: backup
Other Identifiers
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Pro00006972
Identifier Type: -
Identifier Source: org_study_id