Pain and Infection After Transvaginal Colectomy (TVC)

Prospective Evaluation of a Laparoscopic-Assisted Transvaginal Approach for Colonic Resection

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.

Study Overview

• Status: Unknown
• Conditions: Colonic Resection Procedures
• Intervention / Treatment: Procedure: Laparoscopic-Assisted Natural Orifice Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Rachel Karlnoski, PhD; Email: rkarlnos@health.usf.edu
      • Contact: Thanh Tran, MS; Email: thanhtran@health.usf.edu
      • Principal Investigator: Jaime Sanchez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Traditional Laparoscopic-Assisted Colectomy
Experimental: Transvaginal Laparoscopic-Assisted Colectomy; Laparoscopic-Assisted Natural Orifice Surgery	Procedure: 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 Names: Natural Orifice Transluminal Endoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-operative Infections	To evaluate the effects of a laparoscopic-assisted transvaginal colonic resection on postoperative recovery, as measured primarily by surgical site infection rates, compared to standard laparoscopic-assisted colonic resection.	Post-operative day 1 through 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain	1. Pain score assessments: The investigator's staff will provide a rating scale to the patients to self-rate and record their pain at baseline (prior to surgery), at 24, 48, 72, 96, 120, 144 and 168 hours following the procedure end time (or discharge if earlier), and at 14 ± 7 days, 30 ± 7 days, 60 ± 14 days, and 12 months ± 14 days postoperatively using a 10 point visual analogue and pain faces scale where 0 is for no pain and 10 is for the worst pain imaginable. . These data will be recorded using the Pain Assessment Form. In addition, the amount of narcotic pain medication administered through postoperative day 7 (or discharge if earlier) will be recorded and analyzed as morphine equivalents.	Post-operative day 1 through 1 year

Collaborators and Investigators

• Sponsor: Jaime Sanchez
• Investigators: Principal Investigator: Jaime Sanchez, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Pro00006972