Clinical trial NCT06909058: Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures
Official title: Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Care
MIGS
Keywords: postoperative care
minimally invasive gynecologic surgery
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative recovery
timeFrame: The RI-10 will be completed by the patient at two time points: 1 week post-surgery, and 2 weeks post-surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within 2 weeks postoperatively
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Care New England - Women and Infants Hospital
name: Christine Foley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brolmann HA, Vonk Noordegraaf A, Bruinvels DJ, de Vet RH, Dirksz AA, Huirne JA. Can prolonged sick leave after gynecologic surgery be predicted? An observational study in The Netherlands. Surg Endosc. 2009 Oct;23(10):2237-41. doi: 10.1007/s00464-008-0287-0. Epub 2009 Jan 1.
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citation: Weir LF, Nygaard IE, Wilken J, Brandt D, Janz KF. Postoperative activity restrictions: any evidence? Obstet Gynecol. 2006 Feb;107(2 Pt 1):305-9. doi: 10.1097/01.AOG.0000197069.57873.d6.
citation: Winkelman WD, Erlinger AL, Haviland MJ, Hacker MR, Rosenblatt PL. Survey of Postoperative Activity Guidelines After Minimally Invasive Gynecologic and Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Dec 1;26(12):731-736. doi: 10.1097/SPV.0000000000000697.
citation: Mueller MG, Kenton K. Activity Restrictions After Gynecologic Surgery. Obstet Gynecol. 2024 Mar 1;143(3):378-382. doi: 10.1097/AOG.0000000000005501. Epub 2024 Jan 11.