Colonic Resection ProceduresTVCNCT01942330
Pain and Infection After Transvaginal Colectomy
A study testing Laparoscopic-Assisted Natural Orifice Surgery in people with Colonic Resection Procedures, run by Jaime Sanchez at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Resection Procedures
- What is being tested?
- Laparoscopic-Assisted Natural Orifice Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Rachel Karlnoski, PhD, rkarlnos@health.usf.edu
Thanh Tran, MS, thanhtran@health.usf.edu
About this study
Official title: 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.
- Conditions
- Colonic Resection Procedures
- Being tested
- Laparoscopic-Assisted Natural Orifice Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic-Assisted Natural Orifice SurgeryProcedure or surgery
Also called Natural Orifice Transluminal Endoscopic 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Laparoscopic-Assisted Colectomy | No intervention | Not described |
| Transvaginal Laparoscopic-Assisted Colectomy | Experimental | Laparoscopic-Assisted Natural Orifice Surgery Receives: Procedure: Laparoscopic-Assisted Natural Orifice Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative day 1 through 1 year
Secondary outcomes (1)
Post-operative Pain
- 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.
Measured: Post-operative day 1 through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Resection ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaime Sanchez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaime Sanchez, University of South Florida
- Investigators
- Jaime Sanchez, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942330
- Sponsor's protocol ID
- Pro00006972
- Acronym
- TVC
- Status last verified
- Oct 2017
- First submitted
- 10 Sep 2013
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Laparoscopic-Assisted Transvaginal Approach for Colonic Resection
- ClinicalTrials.gov ID
- NCT01942330
- Acronym / sponsor ID
- TVC / Pro00006972
- Conditions
- Colonic Resection Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Jaime SanchezUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2018 (estimated)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Laparoscopic-Assisted Colectomy | No intervention | – |
| Transvaginal Laparoscopic-Assisted Colectomy | Experimental | Procedure: Laparoscopic-Assisted Natural Orifice SurgeryLaparoscopic-Assisted Natural Orifice Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic-Assisted Natural Orifice SurgeryAlso: Natural Orifice Transluminal Endoscopic SurgerySurgical 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. | Procedure or surgery | Transvaginal Laparoscopic-Assisted Colectomy |
Primary outcome
Incidence of Post-operative Infections
Time frame: 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.
1 secondary outcome
Post-operative Pain
Time frame: Post-operative day 1 through 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Sanchez, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic-Assisted Natural Orifice Surgery in people with Colonic Resection Procedures, run by Jaime Sanchez at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-operative Infections (time frame: Post-operative day 1 through 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.