NCT06909058

Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Anna Frappaolo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Care
• MIGS

Interventions

Type	Name	Description
BEHAVIORAL	Study 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.

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-06-16
• Completion: 2026-07-01
• First posted: 2025-04-03
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States