Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures
NCT ID: NCT06909058
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
148 participants
INTERVENTIONAL
2025-04-07
2026-02-01
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control. Patients to receive standard postoperative instructions.
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.
No interventions assigned to this group
Study. Patients to receive liberalized postoperative instructions.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Primary language other than English (or Spanish once forms are professionally translated and approved)
* Use of port size \>8mm
18 Years
FEMALE
Yes
Sponsors
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Anna Frappaolo
OTHER
Responsible Party
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Anna Frappaolo
OBGYN Resident Physician
Principal Investigators
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Christine Foley, MD
Role: PRINCIPAL_INVESTIGATOR
Care New England - Women and Infants Hospital
Locations
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Women and Infants Hospital
Providence, Rhode Island, United States
Countries
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References
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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.
Kluivers KB, Hendriks JC, Mol BW, Bongers MY, Vierhout ME, Brolmann HA, de Vet HC. Clinimetric properties of 3 instruments measuring postoperative recovery in a gynecologic surgical population. Surgery. 2008 Jul;144(1):12-21. doi: 10.1016/j.surg.2008.03.027. Epub 2008 May 21.
Min J, Kim JY, Ryu J, Park S, Courneya KS, Ligibel J, Kim SI, Jeon JY. Early Implementation of Exercise to Facilitate Recovery After Breast Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Aug 1;159(8):872-880. doi: 10.1001/jamasurg.2024.1633. Erratum In: JAMA Surg. 2024 Aug 1;159(8):960. doi: 10.1001/jamasurg.2024.2885.
Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
Arunachalam D, Heit MH. Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial. Int Urogynecol J. 2020 Jul;31(7):1337-1345. doi: 10.1007/s00192-020-04239-y. Epub 2020 Feb 15.
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.
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.
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.
Other Identifiers
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2221729
Identifier Type: -
Identifier Source: org_study_id
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