Clinical trial NCT01942330: Pain and Infection After Transvaginal Colectomy
Official title: Prospective Evaluation of a Laparoscopic-Assisted Transvaginal Approach for Colonic Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Resection Procedures
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for colonic resection in adult women that eliminates the need for an abdominal incision to remove surgical specimens. It is hypothesized that this LANOS technique will improve patient outcomes such as postoperative surgical site infection (SSI) rates, thereby improving patient satisfaction and also reducing hospital length-of-stay and cost.


Eligibility criteria: Inclusion Criteria:

1. Females ≥ 18 years of age
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:

1. Current pregnancy or considering becoming pregnant during the follow-up period or within 6 months of surgery
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.

Primary outcomes:
measure: Incidence of Post-operative Infections
timeFrame: Post-operative day 1 through 1 year
Secondary outcomes:
measure: Post-operative Pain
timeFrame: Post-operative day 1 through 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Jaime Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: