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Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Completed

Conditions

Satisfaction
Hysterectomy
Minimally Invasive Surgery
Postoperative

Treatments

Other: postoperative follow up appointment

Study type

Interventional

Funder types

Other

Identifiers

NCT03642743
18.0481

Details and patient eligibility

About

This prospective, randomized control trial will evaluate patient satisfaction with the number of postoperative follow up visits after minimally invasive hysterectomy for the treatment of non-cancerous conditions at an urban academic hospital in Louisville, Kentucky. Patients will be randomized to receive either a two and six week postoperative follow up visits versus a postoperative follow up visit at six weeks alone.

Full description

The objective of follow up appointments following benign gynecologic surgery is to ensure adequate postoperative recovery, assess additional patient concerns, and to identify and manage any delayed postoperative complications. There is limited literature addressing short-term postoperative follow up for benign gynecologic surgery, particularly those performed through a minimally invasive approach.

The benefits of minimally invasive surgery includes shorter operative time, reduced hospital stay, improved cosmesis, and faster recovery especially when combined with enhanced recovery after surgery (ERAS) protocols. However, this does not negate the need for follow up. Although no consensus exists on the appropriate frequency and number of postoperative appointments, there is no debate on its value.

Due to lack of evidence on this issue, the number and frequency of postoperative appointments is currently dependent on surgeon preference, type of procedure performed and complications encountered intraoperatively and postoperatively, which could lead to patient confusion and unnecessary cost and hassle.

For this reason, investigation of outcomes based on the number and frequency of postoperative follow up visits may improve optimal patient satisfaction, improve compliance and provide early detection of postoperative complications. Such knowledge could serve to mitigate efforts to develop and implement protocols to improve compliance with postoperative follow-up care, potentially reduce emergency room visits, readmissions, empower patients and reduce cost.

Enrollment

174 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of University of Louisville gynecology providers age 18-70 who are planning to undergo a minimally invasive hysterectomy for benign indications.
  • Incident surgery must be performed at the University of Louisville Hospital (or affiliated hospital attended by a provider affiliated with the academic department).

Exclusion criteria

  • Patients with decreased mental capacity who are unable to consent.
  • Patients who do not have sufficient English proficiency to complete or understand informed consent for the surgery or study questionnaires.
  • Patients with unreliable access to a telephone.
  • Patients with significant medical comorbidities that would necessitate more frequent follow up.
  • Patients for whom the planned number of follow ups have been pre-determined at the pre-operative visit due to a certain medical need or condition.
  • Patients who report an inability to comply with postoperative follow up in either group to which they could be randomized.
  • Women who decide at their preoperative visit they do not desire or cannot undergo benign gynecologic surgery as scheduled.
  • Women who have medical contraindication to undergoing the benign gynecologic surgery that was planned prior, as determined in their best interest by their provider

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

174 participants in 2 patient groups

Two and six week follow up
Experimental group
Description:
Patients will be assigned to routine two and six week postoperative follow up appointments
Treatment:
Other: postoperative follow up appointment
Six week follow up only
Experimental group
Description:
Patients will be assigned to a single six week postoperative follow up appointment
Treatment:
Other: postoperative follow up appointment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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