Pain and Infection After Transvaginal Colectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonic Resection Procedures

Intervention / Treatment
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* Procedure: Laparoscopic-Assisted Natural Orifice Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females ≥ 18 years of age 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 Willingness and ability to comply with the requirements of the study protocol including follow-up Willingness and ability to sign the study specific informed consent Exclusion Criteria: Current pregnancy or considering becoming pregnant during the follow-up period or within 6 months of surgery 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. Body Mass Index (BMI) > 35 Vaginal stenosis Prior reconstructive surgery of the vagina not including hysterectomy ASA classes 4 and 5 Advanced renal insufficiency (estimated creatinine clearance ≤30 mL/min/1.73 m2) Any history of pelvic radiation Anticipated need for an ostomy at the time of operation Patients requiring urgent or emergent surgery Patients with prior or suspected diagnosis of inflammatory bowel disease such as Crohns disease or ulcerative colitis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional Laparoscopic-Assisted Colectomy<br> | |
| Experimental: Transvaginal Laparoscopic-Assisted Colectomy<br>Laparoscopic-Assisted Natural Orifice Surgery | Procedure: Laparoscopic-Assisted Natural Orifice Surgery<br>* 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.<br>* Other names: Natural Orifice Transluminal Endoscopic Surgery;|

What is the study measuring?
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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 |