Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

NCT06909058 | Active Not Recruiting

• 1 other identifier: 2221729
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Care; MIGS

Keywords

postoperative care; minimally invasive gynecologic surgery

Outcome Measures

Primary Outcomes (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.

  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)

• Postoperative complications

  Within 2 weeks postoperatively

Study Arms (2)

Control. Patients to receive standard postoperative instructions.

NO 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.

Study. Patients to receive liberalized postoperative instructions.

EXPERIMENTAL

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.

Behavioral: Study Postoperative Care

Interventions

Study Postoperative Care BEHAVIORAL

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. Patients to receive liberalized postoperative instructions.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years of age
• English speaking (Spanish speaking to be added once appropriate forms are professionally translated and approved)
• mm port sites used during the surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Frappaolo: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (8)

• 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.

  PMID: 19118421 RESULT

• 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.

  PMID: 18571580 RESULT

• 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.

  PMID: 38837150 RESULT

• 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.

  PMID: 28277355 RESULT

• 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.

  PMID: 32062677 RESULT

• 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.

  PMID: 16449116 RESULT

• 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.

  PMID: 30707119 RESULT

• 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.

  PMID: 38207325 RESULT

Study Officials

• Christine Foley, MD

  Care New England - Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: OBGYN Resident Physician

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 7, 2025
• Primary Completion: January 16, 2026
• Study Completion: February 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)