Surgical Consent Process for Trans-obturator Tape Slings.
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|ClinicalTrials.gov Identifier: NCT02750878|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Other: Informational Handout||Not Applicable|
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:
- Control Group: Participants will receive only the standard verbal TOT surgical consent counseling described above.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of the Consent Process for Patients Undergoing Trans-obturator Tape Slings.|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
No Intervention: Control group
Participants will receive only the standard verbal TOT surgical consent counseling.
Participants will receive the standard verbal TOT surgical consent counseling plus a handout describing their surgical intervention
Other: Informational Handout
- A knowledge questionnaire at the pre-operative holding area to measure the patients' knowledge regarding their Trans Obturator Tape surgery. The percentage of correct answers will be reported and analyzed. [ Time Frame: On the day of Trans Obturator Tape surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750878
|Contact: Eman Elkadry, MDfirstname.lastname@example.org|
|Contact: Hussein Warda, MDemail@example.com|
|United States, Massachusetts|
|Mount Auburn Hospital||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Kathleen Rogers 617-354-5452 firstname.lastname@example.org|