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Postoperative CareNCT06909058

Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

A study testing Study Postoperative Care in people with Postoperative Care and MIGS, run by Anna Frappaolo at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postoperative Care, MIGS
What is being tested?
Study Postoperative Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteUnited States
Study dates
7 Apr 2025to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

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.

Read the 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.

Being tested
Study Postoperative Care
Keywords
postoperative care, minimally invasive gynecologic surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study Postoperative CareBehavioural

    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.

Study groups in NCT06909058
Study groupRoleWhat they receive
Control. Patients to receive standard postoperative instructions.No interventionParticipants 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.ExperimentalParticipants 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.
Receives: Behavioral: Study Postoperative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative recovery

    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.

    Measured: The RI-10 will be completed by the patient at two time points: 1 week post-surgery, and 2 weeks post-surgery

Secondary outcomes (1)

  1. Postoperative complications

    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.

    Measured: Within 2 weeks postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start7 Apr 2025
  3. Primary completion16 Jun 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909058
Sponsor's protocol ID
2221729
Status last verified
Apr 2026
First submitted
27 Mar 2025
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19118421

  • 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.

    PubMed 18571580

  • 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.

    PubMed 38837150

  • 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.

    PubMed 28277355

  • 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.

    PubMed 32062677

  • 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.

    PubMed 16449116

  • 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.

    PubMed 30707119

  • 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.

    PubMed 38207325

Questions about this trial

What is this clinical trial studying?

A study testing Study Postoperative Care in people with Postoperative Care and MIGS, run by Anna Frappaolo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06909058, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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