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

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is minimally invasive gynecologic surgery generally safe for humans?

Research shows that minimally invasive gynecologic surgery, including robotic-assisted and laparoscopic procedures, is generally safe, with studies evaluating adverse events and safety protocols to minimize risks. Guidelines have been developed to enhance recovery and optimize care, focusing on safety measures like managing pain and preventing complications. ^{1 2 3 4 5}

How is the postoperative care treatment for minimally invasive gynecologic surgery different from other treatments?

This treatment is unique because it follows the Enhanced Recovery After Surgery (ERAS) guidelines, which are specifically designed to optimize care for women undergoing minimally invasive gynecologic surgery. It focuses on improving recovery through specific recommendations for managing conditions like anemia and sleep apnea, and emphasizes same-day discharge and multimodal pain management to enhance safety and efficiency. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Postoperative Restrictions in postoperative care for minimally invasive gynecologic surgery?

Enhanced recovery protocols, which include minimizing unnecessary postoperative restrictions, have been shown to reduce hospital stays, lower costs, and decrease the need for opioids in gynecologic surgeries, suggesting that limiting unnecessary restrictions can improve recovery. ^{7 10 11 12 13}

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. United States pubmed.ncbi.nlm.nih.gov

Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cost impact analysis of enhanced recovery after minimally invasive gynecologic oncology surgery. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery in gynecologic oncology. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A Full Enhanced Recovery after Surgery Program in Gynecologic Laparoscopic Procedures: A Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Enhanced recovery in gynecologic surgery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

MAUDE: analysis of robotic-assisted gynecologic surgery. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Enhanced Recovery and Surgical Optimization Protocol for Minimally Invasive Gynecologic Surgery: An AAGL White Paper. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Audit of preoperative and early complications of laparoscopic lymph node dissection in 1000 gynecologic cancer patients. [2006]

9. England pubmed.ncbi.nlm.nih.gov

Safety and Feasibility Analysis of Laparoscopic Lymphadenectomy in Pelvic Gynecologic Malignancies: A Prospective Study. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Hospital costs associated with adverse events in gynecological oncology. [2011]

11. United States pubmed.ncbi.nlm.nih.gov

Survey of Postoperative Activity Guidelines After Minimally Invasive Gynecologic and Pelvic Reconstructive Surgery. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Surgery in Morbidly Obese Women. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Same-day Hospital Discharge after Minimally Invasive Hysterectomy in a Gynecologic Oncology Practice: Feasibility, Safety, Predictors of Admission, and Adverse Outcomes. [2022]