Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

Anna Frappaolo

Status: Active, not recruiting

Conditions: Postoperative Care; MIGS

Treatments: Behavioral: Study Postoperative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06909058

2221729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Control. Patients to receive standard postoperative instructions.

No Intervention group

Description:

Participants in the control group will receive standard postoperative instructions which would be given whether the patient was enrolled in this study or not. This includes written and verbal instructions not to lift anything heavier than 10 pounds, or partake in rigorous exercise (weightlifting, sit-ups) for at least 2 weeks postoperatively.

Study. Patients to receive liberalized postoperative instructions.

Experimental group

Description:

Participants in the study group will receive liberal postoperative instructions. This includes written and verbal instructions to resume normal activities of daily living without restriction at the discretion of the patient.

Treatment:

Behavioral: Study Postoperative Care