Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial
Phase: NA
Conditions: Patient Satisfaction
Sponsor: Jackson, Elisha

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Project Title: Preferred Method of Postoperative Follow Up After Pelvic 
Reconstructive Surgery. (Phone Call versus Clinic Visit): A Non-Inferiority 
Randomized Clinical Trial  
 
 
Primary Investigator: Elisha Jackson, MD 
Fellowship Program: University of South Florida 
Year: PGY 6 
 
Co-investigators: 
Renee Bassaly, DO 
Kristie Greene, MD  
Allison Wyman, MD 
Simon Patton, MD  
Isabel Prieto, MD  
 
 
 
 
 
I.  Introduction:  
 
 
Post-operative visits two weeks following reconstructive pelvic surgery is standard 
practice for our FPMRS division. With a growing number of new patients, scheduled 
procedures, and established patients, we, like most academic practices, struggle 
with maintaining an efficient workflow. To provide the best care, it is necessary to 
evaluate how we can improve patient satisfaction without seeing an increase in 
complications. Telephone consultations are increasingly being used as a novel 
approach to supplement or replace traditional outpatient care for various acute or 
chronic conditions. [1]. A review article published by Car, J and Sheikh, A found that 
telephone consultations are associated with increased patient satisfaction, less 
waiting time, and reduced travel costs. They also reviewed studies that both 
clinicians and patients value the convenience and flexibility offered by telephone 
consultations. However, amongst physicians dissatisfied with telephone -based care, 
the concerns cited included inability to confirm diagnosis with an examination and 
absence of visual cues [2].  Telephone follow up has been favorably evaluated 
following laparoscopic cholecystectomy, hernia repair, cardiovascular surgery, and 

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in oncology [2].  
In the setting of urogynecological procedures, the use of telephone follow up is an 
area that needs to be studied. There is no known standardization about how 
postoperative follow up visits are conducted after pelvic reconstructive surgery. 
There is much variation amongst providers concerning when and how 
postoperative follow up visits are completed. With the advances in robotic and 
laparoscopic procedures, hospital length of stay has decreased significantly. We now 
must examine the benefits of minimally invasive surgery as it relates to 
postoperative follow up. If in person postoperative visits can be replaced with 
telephone visits, we can possibly increase patient satisfaction. By allowing the 
patient to have a postoperative visit in the comfort of her own home, we can save 
her travel costs and travel time. Additionally, in our practice, the in person 
postoperative visits can ultimately be replaced with procedures and established 
patient visits, ultimately allowing for more availability for new patient 
consultations. By evaluating the use of telephone follow up, versus clinic follow up 
we will show that patient satisfaction with telephone follow up will be unchanged or 
improved compared to our standard practices.   
 
 
II.  Objective: 
 
A. Primary Aim(s):  
• To determine if patient satisfaction with postoperative care with telephone 
follow up is non-inferior to clinic follow up.    
 
    B. Secondary Aim(s):   
• To determine if telephone postoperative follow up is a safe alternative to 
clinic postoperative follow up visits  
• To determine if telephone or clinic follow up visits are preferred based on 
differing demographics (i.e. age, race, distance traveled, outpatient versus 
inpatient surgery). 
• To determine length of visit differences between telephone and clinic follow 
up.  
 
 
 
III.  Hypothesis:   
 
For the standard two-week postoperative visit, follow up telephone calls will be 
non-inferior to traditional office visits. The telephone visit is a safe and efficient 
alternative to the in person visit following urogynecological procedures.  
 
 
a. H0 Traditional office visits are superior to follow up via telephone calls for 
two-week postoperative visits.  

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IV. Interventions:   
 
Scheduled telephone call at the two-week postoperative visit completed by the 
urogynecology clinic nurse. 
 
V.  Study Design: 
This is a two group, parallel randomized non-inferiority clinical trial at one 
institution evaluating telephone postoperative visits as non-inferior in patient 
satisfaction, patient preference, and patient safety, when compared with clinic 
postoperative visits. This protocol was written in accordance with CONSORT 
(Consolidated Standards of Reporting Trials) guidelines 2011.   
 
VI:  Methods: 
A. Study Setting: 
Patient recruitment will come from women presenting for their follow up clinic visit 
at the University of South Florida’s (USF) Female Pelvic Medicine and 
Reconstructive Surgery (FPMRS) Clinic.  Women who present to this follow up clinic 
visit have already been seen and evaluated within USF’s FPMRS clinic by one of the 
FPMRS faculty, have undergone appropriate testing and are now receiving detailed, 
focused counseling in order to decide upon preferred surgical management. At this 
point a letter is sent to schedule the desired procedure.  Once the physician and 
patient have agreed upon the surgical management plan it is the routine practice, at 
our institution, to submit a letter to the surgical scheduler. The letter details the 
type of surgery, medical clearance requests, and postoperative follow up. The 
patient is informed that she will be contacted, by our office, in the next two weeks 
and provided with all necessary information and documentation, including date of 
surgery and follow up appointments. It will be at this follow up clinic visit that 
patients will be told about our study and consented if applicable.  
 
B.  Eligibility: 
 
The women that present to the USF FPMRS follow up visit and have decided to 
undergo surgical management of prolapse or incontinence, will be assessed to 
determine if they meet eligibility requirements.  Eligibility requirements are as 
follows: 
 
1.  Inclusion Criteria:  
• Women >18 desiring surgical management of prolapse or incontinence  
• English speaking 
• Willing and able to provide written and informed consent without assistance 
from medical surrogate or interpreter  

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• Immediate access to telephone services (landline, mobile phone, office 
phone)  
 
 
2.  Exclusion Criteria: 
• Women <18  
• Non-English speaking 
• Unwilling and unable to provide written and informed consent without 
assistance from surrogate or interpreter  
• Hearing impairment  
• No access to telephone services (landline, mobile phone, office phone) 
• Grade 3 complication- a complication requiring surgical, endoscopic, or 
radiological intervention. [3] 
• Patient who did not attend any postoperative follow up visit  
 
 
 
C. Interventions and Recruitment: 
The recruitment and consenting process will be performed by an FPMRS fellow or 
an attending physician and will occur in a private patient exam room at the time of 
the surgical consultation follow up visit. After obtaining informed consent, the 
women will be randomized to either a two-week postoperative telephone visit or 
two- week postoperative clinic visit. The preferred contact phone number and 
mailing address will be confirmed.  The patient will also receive a brief outline 
summarizing the study and what to expect in laymen terms. These visits typically 
occur during each of the three attending physicians’ clinics. The provider will 
include that the patient is a study patient in the surgery letter. Once the surgical 
scheduler confirms that the patient has been enrolled and consented, she will open 
the next sealed randomization envelope revealing the patient’s allocated 
intervention and schedule the patient’s two- week postoperative visit accordingly 
(telephone follow up or clinic follow up). If the patient is randomized to telephone 
follow up, the surgical scheduler will again confirm the preferred contact number 
and mailing address.  
 
Concerning the two-week postoperative follow up visit, if the patient is randomized 
into the telephone follow up group, she will be contacted, at the pre-scheduled date 
and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series 
of postoperative questions, which are consistent with questions asked during our 
standard postoperative clinic visits. The same nurse will conduct the telephone 
follow up visits in an effort to maintain consistency. An example of the script is 
attached.   
Any patient responses that are not consistent with a usual postoperative course will 
be escalated to an in person visit. However, these patients will remain in the group, 
to which they were originally randomized, for research analysis purposes. If a 
patient cannot be reached at the time of her scheduled telephone visit, a second 

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telephone call will be attempted during the same week. If there is still no answer, 
the patient will be scheduled for an in person visit, the time and date of this visit will 
be left on the patients voicemail. Patient will be excluded from study. Patients who 
were found to have recovered satisfactorily based on telephone follow up, will have 
six -week clinic visit.  
Vital signs and physical examination will be deferred for the patients in the 
telephone follow up group. The clinic visit will entail questions about common 
postoperative complications (including fever, nausea/vomiting, pain, urinary 
symptoms, constipation, etc.). As per usual, vital signs and a focused physical 
examination will be completed at the clinic visit. All clinic visits will be performed by 
an FPRMS fellow and/or attending physician. At the end of each visit (telephone and 
clinic) patient will be reminded about postoperative restrictions as outlined in 
discharge instructions. The length of duration of both the telephone and clinic visits 
will be recorded by documenting the start and end time. For the clinic visit the start 
time will be the time patient is documented as “arrived” status in waiting area and 
finish time when the physician leaves the room. For the telephone visit, the start 
time will be at the time the patient answers the phone and finish time when phone 
call ends. Both clinic and telehealth visits will be documented with progress notes in 
EMR.  
 
 
 
 
 
D. Randomization 
 
Eligible patients will be randomized to Arm1 or Arm2 (Telephone follow up or clinic 
follow up). Permuted block randomization with randomly varying block sizes will 
be used. Generation of allocation sequences will be performed using a random-
number table.  
 
E. Concealment of Treatment Allocation: 
The allocation sequence will be generated by our statistician who is neither 
responsible for patient recruitment or outcome assessment.  Sequentially numbered 
opaque sealed envelopes will be used for concealment of treatment allocation. 
 
F. Blinding:   
It is not possible to mask clinical staff or participants, as they will be aware of the 
follow-up care that is being delivered over the telephone or in clinic. As such this is 
not a blinded study. The surgical scheduler will open the sealed randomization 
envelope revealing the patient’s allocated intervention and document this in the 
patients’ chart.  The PI will keep the master link matching the patient to the 
allocated intervention. The PI is also responsible for entering all collected data into a 
de-identified excel spreadsheet.  
 
 

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VII.  Outcomes 
 
 
A. Primary:  
• Comparison of patient satisfaction as determined by completion of a non-
validated, treatment non-specific satisfaction questionnaire between the two 
groups. Survey will be provided at the six-week follow up visit.  
 
 
     B. Secondary:   
• Comparison of adverse events and Emergency Department (ED) visits 
between the two groups. Will be determined by reviewing the patient’s 
record to identify adverse events as defined below. Informed consent will 
include consent to obtain outside ED records; as this is standard practice for 
patients seen in ED during perioperative/postoperative period.  
• Actual time spent on phone call during postoperative telephone follow up 
compared to time spent in clinic follow up measured in minutes.  
• Correlation, between groups, of overall patient’s satisfaction with subjective 
measures, complications, demographics, and travel distance.  
 
 
VIII.  Data Collection: 
 
At the initial visit, once eligibility status is determined and consent is obtained, data 
collection form will include demographics, distance traveled, complications, and 
number of ED visits, type of surgery performed etc. Also patients will complete 
three postoperative patient satisfaction questionnaires at the six-week 
postoperative clinic visit. This will include the Patient Satisfaction Questionnaire 
(PSQ) 18 Short Form, a validated questionnaire. Also will include the Patient Global 
Impression of Improvement (PGII), a validated questionnaire. And a three-question 
survey about patient satisfaction with the postoperative experience, not validated.  
All six -week visits will be in person. The questionnaires will be completed before 
the physician interviews the patient. These questionnaires will be stored in a locked 
filing cabinet and later transferred by the PI to an excel spreadsheet stored on a 
password-protected computer. Additionally, pertinent medical information will be 
extracted from the patient’s medical chart, de-identified, and transferred to the an 
excel spreadsheet after surgery by a member of the study team, including socio-
demographic data, perioperative and postoperative details, adverse events, and ED 
visits.  
 
Adverse events are defined based on previous studies [4, 5,]  
- 
bladder injury 
- 
ureteral injury  
- 
bowel injury  

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- 
operative estimated blood loss >500mL  
- 
reoperation < 30 days  
- 
hematoma 
- 
pelvic abscess  
- 
vaginal cuff cellulitis  
- 
ileus  
- 
small bowel injury  
- 
transfusion  
- 
pulmonary  
- 
cardiac  
- 
neurological injury  
- 
urinary tract infection (culture proven, urinalysis with presence of leukocyte 
esterase, nitrites, or blood, symptoms of infection)  
- 
pyelonephritis  
- 
urinary retention (more than 6 week postoperative)  
- 
mesh erosion  
- 
incisional hernia  
- 
wound complication  
- 
reoperation for complication of surgery  
- 
  
IX.  Sample Size: 
Sample sizes of 71 in Group 1 and 71 in Group 2 achieve 80% power to detect a non-
inferiority margin difference between the group proportions of -0.12. The 
traditional office visit group proportion is 0.87. The Telehealth group proportion is 
assumed to be 0.75 under the null hypothesis of inferiority. The power was 
computed for the case when the actual Telehealth group proportion is 0.90. The test 
statistic used is the one-sided Z test (unpooled). The significance level of the test is 
0.025. 
 
 
X:  Proposed Analyses: 
 
Data analyses will be performed at the University of South Florida in Tampa, Fl. Data 
management and analyses will be conducted using SAS version 9.4 (SAS Institute, 
Inc, Cary,NorthCarolina). Subject demographic characteristics such as age, distance 
traveled, surgical procedures, ED visits will be summarized by standard descriptive 
statistics (e.g. means and standard deviations or median (range) for continuous 
variables and percentages for categorical variables. The difference between groups 
will be compared using the chi-square test or t–test, as appropriate. Logistic linear 
regression will be used to evaluate independent predictors for patient satisfaction.  
A p-value <0.05 will be considered statistically significant.   
 
 
 
VIII.  Confidentiality 
 

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At all times, appropriate measures will be taken to protect the confidentiality of all 
study participants in accordance with HIPAA guidelines.  Patients will be 
approached for recruitment in private patient exam rooms.  Once enrolled, all 
patients will be administered a study ID number starting with 1 and proceeding 
numerically.  A master link between the individual subjects and their study ID 
number will be stored in a secure location (on a password-protected computer in 
the Urogynecology Fellows’ office).  All data collection forms (DCF) and stored 
patient information will only contain the study ID number.  Charts will be reviewed 
in a secure location at all times. Upon completion of the data collection period, all 
information will be entered into an excel spreadsheet on a password-protected 
computer for data analysis.  
 
IX Safety  
 
This a voluntary study. Patients have the right to refuse to participate.   
 
Data and Safety Monitoring 
The study PI will be reviewing the data for completeness and any safety issues on an 
ongoing basis.  An independent urologist will also review the data and safety after 
the enrollment of the first 10 patients, after ~50% recruitment and at the 
completion of the study.  A summary of these reviews will be submitted to the IRB 
as part of the continuing review process. 
 
After providing informed consent, the participants will proceed with the normal 
surgery scheduling process. If the patient is excluded from the study, due to meeting 
the exclusion criteria postoperatively, she will be notified and scheduled for clinic 
visit if she was randomized to the telephone group. At this point the patient will be a 
part of excluded patient population as documented in the CONSORT flow diagram. 
Patient may elect to be removed from the study at anytime.  
 
 
 
 
References: 
 
 
 
1- Connie H. Carr, Helen McNeal, Elaine Regalado, Richard A. Nelesen, and Linda S. Lloyd. 
Journal of Palliative Medicine. February 2013, 16(3): 263-267 
 
2- Car, Josip, and Aziz Sheikh. “Telephone Consultations.” BMJ : British Medical Journal 326.7396 
(2003): 966–969 
 
3- Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical 
complications: five-year experience. Ann Surg. 2009;250:187-196. 
 
 
4- Unger CA, Hickman LC, Mitchell-Handley B, Barber MD, Ridgeway B. The incidence of 

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perioperative adverse events in the very elderly undergoing urogynecologic surgery. Female 
Pelvic Med Reconstr Surg 2016;22:425-429.  
 
5- Brubaker, Linda et al. “Two-Year Outcomes After Sacrocolpopexy With and Without Burch to 
Prevent Stress Urinary Incontinence.” Obstetrics and gynecology 112.1 (2008): 49–55. PMC. 
Web. 1 Feb. 2018. 
 
 
6- 6- Beaver K, Williamson S, Sutton C, Hollingworth W, Gardner A, Allton B, Abdel-Aty 
M, Blackwood K, Burns S, Curwen D, Ghani R, Keating P, Murray S, Tomlinson A, Walker 
B, Willett M, Wood N, Martin-Hirsch P. Comparing hospital and telephone follow-up for patients 
treated for stage–I endometrial cancer (ENDCAT trial): a randomised, multicentre, non-inferiority 
trial. BJOG2017;124:150–160. 
 
7- Bunn F, Byrne G, Kendall S. Telephone consultation and triage: effects on health care use and 
patient satisfaction. Cochrane Database of Systematic Reviews 2004, Issue 3.  
 
 
8- Gray, RT et al. “Post-Operative Telephone Review Is Cost-Effective and Acceptable to Patients.” 
The Ulster Medical Journal 79.2 (2010): 76–79. 
 
9- Hwa K, Wren SM. Telehealth Follow-up in Lieu of Postoperative Clinic Visit for Ambulatory 
SurgeryResults of a Pilot Program. JAMA Surg. 2013;148(9):823-827.  
 
 
10- Anderson ME Jr, Brancazio B, Mehta DK, Georg M, Choi SS, Jabbour N. Preferred parental 
method of postoperative tonsillectomy and adenoidectomy follow up (phonecall vs clinic visit). Int 
J Pediatr Otorhinolaryngol 2017 Jan: 92: 181-185 
 
11- Gunter, Rebecca L et al. “Current Use of Telemedicine for Post-Discharge Surgical Care: A 
Systematic Review.” Journal of the American College of Surgeons 222.5 (2016): 915–927. PMC. 
Web. 23 Mar. 2018.