Recruiting

Observational Study

Sponsor:

Jaime Sanchez

Code:

NCT01942330

Conditions

Colonic Resection Procedures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laparoscopic-Assisted Natural Orifice Surgery

Study Details

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.

Conditions

Colonic Resection Procedures

Study ID

NCT01942330

Start date

Aug, 2013

Status verified date

Oct, 2017

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Traditional Laparoscopic-Assisted Colectomy

experimental: Transvaginal Laparoscopic-Assisted Colectomy

Laparoscopic-Assisted Natural Orifice Surgery

Interventions

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.

Primary outcome measure

  • Incidence of Post-operative Infections [ Time Frame: Post-operative day 1 through 1 year ]

Central Contacts and Locations

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Rachel Karlnoski, PhD

rkarlnos@health.usf.edu

Principal Investigator:

Jaime Sanchez, MD

More Information

Sponsor

Jaime Sanchez

Last update posted

Oct 31, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jaime Sanchez on 2017-10-31.