Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03730103
Eligibility Criteria:
Inclusion Criteria:
* Age \<80 years old
* Preoperative American Society of Anesthesiologists grade I (normal healthy patient) or II (mild systemic disease)
* Access to ancillary care, including phone advice, nurse and outpatient clinic numbers
* Caretaker at home for at least 24 hours post-operatively
* Able to speak and read English
* Has decision-making capacity and able to provide consent for research participation
Exclusion Criteria:
* Laparoscopic, robotic, or open abdominal surgical procedures that require an overnight admission. This may be due to unanticipated additional intraoperative procedures or surgical complications such as unintentional cystotomy or enterotomy, hemorrhage, or anesthetic complication.
* Patients undergoing concomitant laparoscopic colorectal procedures or anal sphincteroplasty
* Surgery start time after 1:00PM, as previous studies have determined this is associated with a decreased likelihood of SDD3,14
* Pregnancy or positive hCG testing, which is standard of care preoperative testing
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03730103
Study Brief:
Protocol Section:
NCT03730103