Surgical Consent Process for Trans-obturator Tape Slings.
| Status: | Recruiting |
|---|---|
| Conditions: | Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/21/2018 |
| Start Date: | November 2015 |
| End Date: | July 2020 |
| Contact: | Eman Elkadry, MD |
| Email: | eelkadry@mah.harvard.edu |
| Phone: | 617-354-5452 |
A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.
The purpose of this study is to determine if addition of a handout to the standard consent
process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve
patients' understanding, recall and satisfaction with their procedure. The information
provided in the handout will include the procedure details, the accompanying risks and
benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the
investigators is to improve and standardize the current process for surgical consent for
patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators
hypothesize that addition of a handout will improve patient's preoperative comprehension by
an absolute value of 10% compared to the standard consent process. The investigators further
hypothesize that the handout will improve patient satisfaction and recall of the surgical
procedure details post operatively.
process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve
patients' understanding, recall and satisfaction with their procedure. The information
provided in the handout will include the procedure details, the accompanying risks and
benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the
investigators is to improve and standardize the current process for surgical consent for
patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators
hypothesize that addition of a handout will improve patient's preoperative comprehension by
an absolute value of 10% compared to the standard consent process. The investigators further
hypothesize that the handout will improve patient satisfaction and recall of the surgical
procedure details post operatively.
This is a randomized controlled trial investigating whether adding an informational handout
to the standard surgical consent will improve patient understanding, recall and satisfaction
with their surgery. The primary outcome will be the patient's knowledge of her surgical
details immediately before surgery. The secondary outcomes will be the patient's
satisfaction, regret scale and the patient's postoperative knowledge of her surgery details.
A member of the research team will recruit eligible patients at their preoperative clinic
visit during the signing of consent for their TOT surgery. Verbal counseling for the TOT
surgical consent is the current standard of practice in the investigator's office. After the
patient is counseled in the usual fashion and signs the consent for her planned TOT surgery,
the patient will be offered participation in the study.
Eligible patients will be consented verbally by the investigators. After enrollment, patients
will be randomized using a computer-generated block randomization scheme to allocate
participants in a 1:1 ratio; randomization will be stratified by provider.
Participants will be randomized to one of two study arms:
1. Control Group: Participants will receive only the standard verbal TOT surgical consent
counseling described above.
2. Intervention Group: Participants will receive the standard verbal TOT surgical consent
counseling plus a handout describing their surgical intervention.
All participants will be asked to complete a baseline questionnaire at the enrollment visit.
Participants randomized to the control group will be finished with this initial study visit
after completing the baseline questionnaire. Participants randomized to the intervention arm
will be given a handout describing the TOT procedure, risks and benefits, post-operative
recovery and alternative treatment options, as discussed in the verbal surgical consent. The
patient will be asked to read the handout and will then be given the handout to take home.
The provider will answer any questions the patient has after reviewing the handout.
The next study encounter will occur in the preoperative area immediately prior to surgery. At
this time all participants will be asked to complete a second questionnaire with questions
similar to those in the baseline questionnaire.
The final study encounter will occur at the post-operative visit that occurs approximately
six weeks after surgery. At this visit all participants will be asked to complete a final
questionnaire. This questionnaire will be the same as the one administered immediately before
surgery. All participants will also be asked to complete an additional questionnaire asking
about satisfaction, regret and surgical experience.
to the standard surgical consent will improve patient understanding, recall and satisfaction
with their surgery. The primary outcome will be the patient's knowledge of her surgical
details immediately before surgery. The secondary outcomes will be the patient's
satisfaction, regret scale and the patient's postoperative knowledge of her surgery details.
A member of the research team will recruit eligible patients at their preoperative clinic
visit during the signing of consent for their TOT surgery. Verbal counseling for the TOT
surgical consent is the current standard of practice in the investigator's office. After the
patient is counseled in the usual fashion and signs the consent for her planned TOT surgery,
the patient will be offered participation in the study.
Eligible patients will be consented verbally by the investigators. After enrollment, patients
will be randomized using a computer-generated block randomization scheme to allocate
participants in a 1:1 ratio; randomization will be stratified by provider.
Participants will be randomized to one of two study arms:
1. Control Group: Participants will receive only the standard verbal TOT surgical consent
counseling described above.
2. Intervention Group: Participants will receive the standard verbal TOT surgical consent
counseling plus a handout describing their surgical intervention.
All participants will be asked to complete a baseline questionnaire at the enrollment visit.
Participants randomized to the control group will be finished with this initial study visit
after completing the baseline questionnaire. Participants randomized to the intervention arm
will be given a handout describing the TOT procedure, risks and benefits, post-operative
recovery and alternative treatment options, as discussed in the verbal surgical consent. The
patient will be asked to read the handout and will then be given the handout to take home.
The provider will answer any questions the patient has after reviewing the handout.
The next study encounter will occur in the preoperative area immediately prior to surgery. At
this time all participants will be asked to complete a second questionnaire with questions
similar to those in the baseline questionnaire.
The final study encounter will occur at the post-operative visit that occurs approximately
six weeks after surgery. At this visit all participants will be asked to complete a final
questionnaire. This questionnaire will be the same as the one administered immediately before
surgery. All participants will also be asked to complete an additional questionnaire asking
about satisfaction, regret and surgical experience.
Inclusion Criteria:
- Adult women ≥age 18
- Consented for TOT mid-urethral sling
- Able to read and understand English
Exclusion Criteria:
- History of surgical treatment for stress urinary incontinence using mid-urethral
slings.
- Patients undergoing concomitant Trans-Obturator Post-Anal Sling (TOPAS) surgery.
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