Pain and Infection After Transvaginal Colectomy

Not Applicable

• Conditions: Colonic Resection Procedures
• Interventions: Procedure: Laparoscopic-Assisted Natural Orifice Surgery

• Registration Number: NCT01942330
• Lead Sponsor: Jaime Sanchez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-31
• Primary Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal Laparoscopic-Assisted Colectomy	Laparoscopic-Assisted Natural Orifice Surgery	Laparoscopic-Assisted Natural Orifice Surgery

Primary Outcome Measures

Name	Time	Method
Incidence of Post-operative Infections	Post-operative day 1 through 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain	Post-operative day 1 through 1 year	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.

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States