MIGS, Postoperative Care
Conditions
Keywords
postoperative care, minimally invasive gynecologic surgery
Brief summary
The goal of this randomized controlled trial is to assess recovery in patients undergoing benign laparoscopic gynecologic surgery. The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery? Researchers will compare postoperative recovery surveys from the control group (patients given standard postoperative restrictions limiting activity for 2 weeks) to the research group (patients given liberalized postoperative instructions allowing them to engage in their normal activities of daily life at their own discretion without prescribed activity restrictions) to see if liberalized postoperative restrictions improve the recovery experience. Participants will be asked to fill out a brief questionnaire at two time intervals, 1 week after surgery and 2 weeks after surgery.
Detailed description
The questionnaire will consist of the Recovery Index-10 (RI-10), a short recovery-specific instrument to assess subjective postoperative recovery that is specifically validated for gynecologic surgery. It is graded on a 5-point numerical Likert scale ranging from "full disagreement" to "full agreement." The questionnaire asks questions regarding pain, stamina/ability to complete daily chores, energy, and sleep. In addition to the RI-10 survey, a few additional questions will be asked to assess whether the patient has dependents they are responsible for, if they have returned to work, and if they have resumed driving.
Interventions
BEHAVIORALStudy Postoperative Care
The study group will be given general postoperative instructions. They will also receive liberal activity restrictions instructing the patient to resume normal activities of daily living at their own discretion without specific restrictions.
Sponsors
Anna Frappaolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than or equal to 18 years of age * English speaking (Spanish speaking to be added once appropriate forms are professionally translated and approved) * 5-8 mm port sites used during the surgery
Exclusion criteria
* Less than 18 years of age * Primary language other than English (or Spanish once forms are professionally translated and approved) * Use of port size \>8mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative recovery | The RI-10 will be completed by the patient at two time points: 1 week post-surgery, and 2 weeks post-surgery | Postoperative recovery will be evaluated using the Recovery Index-10 (RI-10), a recovery-specific instrument to assess subjective postoperative recovery that is specifically validated for gynecologic surgery. It is graded on a 5-point numerical Likert scale ranging from "full disagreement" to "full agreement." The questionnaire asks questions regarding pain, stamina/ability to complete daily chores, energy, and sleep. Prior literature on the use and validation of RI-10 suggests a standard deviation of 20 and an effect size of 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Within 2 weeks postoperatively | Postoperative complications as defined by unscheduled patient contacts for pain or incisional complaints. This could include: ER visits, urgent clinic visits, phone calls regarding incisional complaints, any 30-day readmissions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Foley, MD
Care New England - Women and Infants Hospital
Outcome results
None listed