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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Laparoscopic-Assisted Colectomy | No Intervention | ||
| Transvaginal Laparoscopic-Assisted Colectomy | Experimental | Laparoscopic-Assisted Natural Orifice Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic-Assisted Natural Orifice Surgery | Procedure | 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. |
| 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 |
| 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. |
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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:
Require one of the following elective operations that may be safely performed by current laparoscopic-assisted techniques:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Sanchez, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
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| ID | Term |
|---|---|
| D057605 | Natural Orifice Endoscopic Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
|
| Post-operative day 1 through 1 year |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |