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NCT Number: NCT06909058

Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Postoperative Care MIGS

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Postoperative Care

Behavioral

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.

Primary outcomes

  1. Postoperative recovery

    Time frame: 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 outcomes

  1. Postoperative complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Anna Frappaolo

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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