Minimally Invasive SurgeryNCT03642743
Patient Satisfaction With Postoperative Follow up After Minimally Invasive Hysterectomy
A study testing postoperative follow up appointment in people with Minimally Invasive Surgery and Hysterectomy, run by University of Louisville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Minimally Invasive Surgery, Hysterectomy, Postoperative
- What is being tested?
- postoperative follow up appointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Health Care Outpatient Center and University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Patient Satisfaction With Two and Six Week Postoperative Follow up Appointments After Benign Minimally Invasive Hysterectomy Versus Two Week Postoperative Visit Alone: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Minimally Invasive Surgery, Hysterectomy, Postoperative, Satisfaction
- Being tested
- postoperative follow up appointment
- Keywords
- hysterectomy, minimally invasive surgery, gynecology, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative follow up appointmentOther
Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone
| Study group | Role | What they receive |
|---|---|---|
| Two and six week follow up | Experimental | Patients will be assigned to routine two and six week postoperative follow up appointments Receives: Other: postoperative follow up appointment |
| Six week follow up only | Experimental | Patients will be assigned to a single six week postoperative follow up appointment Receives: Other: postoperative follow up appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
To assess patient satisfaction with the number of postoperative follow up office visits after minimally invasive hysterectomy for benign indications utilizing the Surgical Care - Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician \& Group Survey.
Measured: 6 weeks
Secondary outcomes (1)
Postoperative complication rate
Determine the type and number of postoperative complications as assessed using the Clavien-Dindo Classification system has been selected as a validated and objective measure to collect data pertaining to postoperative complications
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start8 Aug 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive SurgeryStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan Biscette, University of Louisville
- Investigators
- Shan Biscette, MD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642743
- Sponsor's protocol ID
- 18.0481
- Status last verified
- Apr 2021
- First submitted
- 2 May 2018
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091-5. doi: 10.1097/01.AOG.0000285997.38553.4b.
PubMed 17978124Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.
PubMed 28594764Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
PubMed 26264829Slankamenac K, Graf R, Puhan MA, Clavien PA. Perception of surgical complications among patients, nurses and physicians: a prospective cross-sectional survey. Patient Saf Surg. 2011 Nov 22;5(1):30. doi: 10.1186/1754-9493-5-30.
PubMed 22107603Bateman AG, Neilens H, Gericke CA, George J, Freeman RM. Is there a need for postoperative follow-up after routine urogynaecological procedures? Patients will self-present if they have problems. Int Urogynecol J. 2014 Mar;25(3):381-6. doi: 10.1007/s00192-013-2229-1. Epub 2013 Oct 9.
PubMed 24105409Bromage SJ, Napier-Hemy RD, Payne SR, Pearce I. Outpatient follow up appointments; are we using the resources effectively? Postgrad Med J. 2006 Jul;82(969):465-7. doi: 10.1136/pgmj.2005.043547.
PubMed 16822924McVay MR, Kelley KR, Mathews DL, Jackson RJ, Kokoska ER, Smith SD. Postoperative follow-up: is a phone call enough? J Pediatr Surg. 2008 Jan;43(1):83-6. doi: 10.1016/j.jpedsurg.2007.09.025.
PubMed 18206461Scott AR, Rush AJ 3rd, Naik AD, Berger DH, Suliburk JW. Surgical follow-up costs disproportionately impact low-income patients. J Surg Res. 2015 Nov;199(1):32-8. doi: 10.1016/j.jss.2015.04.013. Epub 2015 Apr 10.
PubMed 26013443Tevis SE, Kennedy GD, Kent KC. Is There a Relationship Between Patient Satisfaction and Favorable Surgical Outcomes? Adv Surg. 2015;49(1):221-33. doi: 10.1016/j.yasu.2015.03.006.
PubMed 26299501Shirley ED, Sanders JO. Patient satisfaction: Implications and predictors of success. J Bone Joint Surg Am. 2013 May 15;95(10):e69. doi: 10.2106/JBJS.L.01048.
PubMed 23677370Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Barrie A, Freeman AH, Lyon L, Garcia C, Conell C, Abbott LH, Littell RD, Powell CB. Classification of Postoperative Complications in Robotic-assisted Compared With Laparoscopic Hysterectomy for Endometrial Cancer. J Minim Invasive Gynecol. 2016 Nov-Dec;23(7):1181-1188. doi: 10.1016/j.jmig.2016.08.832. Epub 2016 Sep 9.
PubMed 27621195Hernandez Alava M, Wailoo A, Grimm S, Pudney S, Gomes M, Sadique Z, Meads D, O'Dwyer J, Barton G, Irvine L. EQ-5D-5L versus EQ-5D-3L: The Impact on Cost Effectiveness in the United Kingdom. Value Health. 2018 Jan;21(1):49-56. doi: 10.1016/j.jval.2017.09.004. Epub 2017 Oct 18.
PubMed 29304940Jiang N, Malkin BD. Use of Lean and CAHPS Surgical Care Survey to Improve Patients' Experiences with Surgical Care. Otolaryngol Head Neck Surg. 2016 Nov;155(5):743-747. doi: 10.1177/0194599816657051. Epub 2016 Jun 21.
PubMed 27329420
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Two and Six Week Postoperative Follow up Appointments After Benign Minimally Invasive Hysterectomy Versus Two Week Postoperative Visit Alone: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03642743
- Acronym / sponsor ID
- 18.0481
- Conditions
- Minimally Invasive Surgery, Hysterectomy, Postoperative, Satisfaction
- Keywords
- hysterectomy, minimally invasive surgery, gynecology, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two and six week follow up | Experimental | Other: postoperative follow up appointmentPatients will be assigned to routine two and six week postoperative follow up appointments |
| Six week follow up only | Experimental | Other: postoperative follow up appointmentPatients will be assigned to a single six week postoperative follow up appointment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative follow up appointmentComparison of two and six week postoperative follow up versus a six week postoperative follow up alone | Other | Six week follow up only, Two and six week follow up |
Primary outcome
Patient satisfaction
Time frame: 6 weeks
To assess patient satisfaction with the number of postoperative follow up office visits after minimally invasive hysterectomy for benign indications utilizing the Surgical Care - Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician \& Group Survey.
1 secondary outcome
Postoperative complication rate
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Results publication: PubMed 17978124Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091-5. doi: 10.1097/01.AOG.0000285997.38553.4b.
- Results publication: PubMed 28594764Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.
- Results publication: PubMed 26264829Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
- Results publication: PubMed 22107603Slankamenac K, Graf R, Puhan MA, Clavien PA. Perception of surgical complications among patients, nurses and physicians: a prospective cross-sectional survey. Patient Saf Surg. 2011 Nov 22;5(1):30. doi: 10.1186/1754-9493-5-30.
- Results publication: PubMed 24105409Bateman AG, Neilens H, Gericke CA, George J, Freeman RM. Is there a need for postoperative follow-up after routine urogynaecological procedures? Patients will self-present if they have problems. Int Urogynecol J. 2014 Mar;25(3):381-6. doi: 10.1007/s00192-013-2229-1. Epub 2013 Oct 9.
- Results publication: PubMed 16822924Bromage SJ, Napier-Hemy RD, Payne SR, Pearce I. Outpatient follow up appointments; are we using the resources effectively? Postgrad Med J. 2006 Jul;82(969):465-7. doi: 10.1136/pgmj.2005.043547.
- Results publication: PubMed 18206461McVay MR, Kelley KR, Mathews DL, Jackson RJ, Kokoska ER, Smith SD. Postoperative follow-up: is a phone call enough? J Pediatr Surg. 2008 Jan;43(1):83-6. doi: 10.1016/j.jpedsurg.2007.09.025.
- Results publication: PubMed 26013443Scott AR, Rush AJ 3rd, Naik AD, Berger DH, Suliburk JW. Surgical follow-up costs disproportionately impact low-income patients. J Surg Res. 2015 Nov;199(1):32-8. doi: 10.1016/j.jss.2015.04.013. Epub 2015 Apr 10.
- Results publication: PubMed 26299501Tevis SE, Kennedy GD, Kent KC. Is There a Relationship Between Patient Satisfaction and Favorable Surgical Outcomes? Adv Surg. 2015;49(1):221-33. doi: 10.1016/j.yasu.2015.03.006.
- Results publication: PubMed 23677370Shirley ED, Sanders JO. Patient satisfaction: Implications and predictors of success. J Bone Joint Surg Am. 2013 May 15;95(10):e69. doi: 10.2106/JBJS.L.01048.
- Results publication: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Results publication: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Individual participant dataSharing planned: No
Related trials for Minimally Invasive Surgery
RecruitingPhase 3
First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.
Oligometastatic Non-small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 4
Methadone Versus Standard of Care for Pain Control in Minimally Invasive Lung Resection Surgery
Pain Management
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
RecruitingObservational study
High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes
Uveal Melanoma, High-risk Uveal Melanoma
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Biscette, MD principal investigator
University of Louisville School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative follow up appointment in people with Minimally Invasive Surgery and Hysterectomy, run by University of Louisville 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction (time frame: 6 weeks). 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 NCT03642743, which also lists 24 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 26 Apr 2021.