Postoperative Care for Minimally Invasive Gynecologic Surgery

Overseen By Anna M Frappaolo, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Anna Frappaolo

Disqualifiers: Under 18, Non-English, Large port size

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if recovery improves after minimally invasive gynecologic surgery when patients choose their activity level instead of adhering to strict rest orders. Researchers will compare two groups: one will follow the usual advice of limited activity, while the other will engage in normal activities as they feel comfortable. The trial targets individuals who have undergone laparoscopic gynecologic surgery using small incisions (5-8 mm port sites). English-speaking individuals who have had this type of surgery may be suitable candidates. Participants will complete short surveys one and two weeks post-surgery to share their recovery experiences. As an unphased trial, this study offers a unique opportunity to enhance understanding of recovery processes and potentially improve post-surgery guidelines.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that liberalized postoperative instructions are safe for patients undergoing minimally invasive gynecologic surgery?

Research has shown that relaxing strict post-surgery rules can be safe for patients. One study found that allowing patients to resume normal activities soon after pelvic surgery did not lead to worse outcomes. Patients recovered just as well as those who followed stricter guidelines. Another study highlighted positive outcomes with less strict recovery plans for minimally invasive surgeries, indicating that patients generally manage these plans well. Although data specifically for gynecological surgeries is limited, existing evidence suggests it is safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more relaxed approach to postoperative care after minimally invasive gynecologic surgery. Unlike standard postoperative instructions, which typically advise against lifting heavy objects or engaging in strenuous activities for a couple of weeks, the study's approach encourages patients to resume their normal activities at their own pace. This method could potentially speed up recovery times and improve patient comfort and satisfaction by allowing greater flexibility based on individual readiness.

What evidence suggests that liberalized postoperative instructions improve recovery after laparoscopic gynecologic surgery?

This trial will compare two approaches to postoperative care for minimally invasive gynecologic surgery. Participants in one arm of the trial will receive liberalized postoperative instructions, allowing them to resume normal daily activities at their own discretion. Research has shown that giving patients more freedom in their activities after such surgeries might aid faster recovery. Studies on improved recovery plans have found positive results, such as a quicker return to normal life. Although many doctors still advise limiting activities, early findings support the idea that more flexible guidelines could be beneficial. Evidence suggests that easing restrictions after surgery may enhance patient recovery. ^{1 2 5 6 7}

Who Is on the Research Team?

Christine Foley, MD

Principal Investigator

Care New England - Women and Infants Hospital

Are You a Good Fit for This Trial?

This trial is for patients who have undergone benign laparoscopic gynecologic surgery and are in the postoperative phase. The study is open to those willing to complete recovery surveys but excludes individuals with specific conditions that may interfere with the trial.

Inclusion Criteria

My surgery involved 5-8 mm incisions for ports.

Exclusion Criteria

Use of port size >8mm

I am under 18 years old.

My primary language is not English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo benign laparoscopic gynecologic surgery and receive either standard or liberalized postoperative instructions

2 weeks

2 visits (in-person)

Follow-up

Participants complete the Recovery Index-10 (RI-10) questionnaire to assess postoperative recovery

2 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Postoperative Restrictions

Trial Overview The study tests whether fewer restrictions after minimally invasive gynecologic surgery (letting patients do normal activities right away) lead to better recovery compared to standard care, which limits activity for two weeks.

How Is the Trial Designed?

Group I: Study. Patients to receive liberalized postoperative instructions. Experimental Treatment 1 Intervention

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.

Group II: Control. Patients to receive standard postoperative instructions. Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Anna Frappaolo

Lead Sponsor

Published Research Related to This Trial

In a study of 369 patients undergoing gynecological surgeries, 26% experienced adverse events (AEs), leading to an average additional hospitalization cost of AU$12,780 per patient.

Reducing AEs by 40% could potentially save the healthcare system up to AU$20.6 million per year, highlighting the importance of implementing evidence-based interventions to minimize these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital costs associated with adverse events in gynecological oncology. Kondalsamy-Chennakesavan, S., Gordon, LG., Sanday, K., et al.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06909058

Study Details | NCT06909058 | Postoperative Restrictions ... The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery? Researchers ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12188281/

Minimally Invasive Gynecologic Surgery and Enhanced ... The implementation of ERAS within minimally invasive gynecologic procedures leads to considerable positive results in postoperative outcomes.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30707119/

Survey of Postoperative Activity Guidelines After Minimally ... Most surgeons recommend restriction of activities after minimally invasive gynecologic and pelvic reconstructive surgery.

4. researchgate.net researchgate.net/publication/343763948_Enhanced_Recovery_and_Surgical_Optimization_Protocol_for_Minimally_Invasive_Gynecologic_Surgery_An_AAGL_White_Paper

Enhanced Recovery and Surgical Optimization Protocol for ... The guideline focuses on workflows important to high value care in minimally invasive surgery (MIS), such as same day discharge (SDD) and ...

5. ajog.org ajog.org/article/S0002-9378(18)30496-4/pdf

Implementation of a urogynecology-specific enhanced ... Variations of the protocol are being adopted for gynecological procedures despite limited population and procedure-specific outcome data. Our objective was to ...

6. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2805403

Standard Restrictions vs Expedited Activity After Pelvic ... Expedited postoperative activity instructions after prolapse surgery resulted in noninferior symptomatic and anatomic outcomes at 3 months.

7. ajog.org ajog.org/article/S0002-9378(18)30496-4/fulltext

Implementation of a urogynecology-specific enhanced ... Variations of the protocol are being adopted for gynecological procedures despite limited population and procedure-specific outcome data. Our ...