Outpatient Endometrial Biopsy Results; a Quality Improvement Project.
Conditions: Histopathology, Screening Tool, Techniques
Sponsor: Cairo University

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Title: Outpatient endometrial biopsy results; a quality improvement project. 
 
Date: 4/11/2024 
 
NCT06694246 
 
 

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CLINICAL AUDIT PROJECT PLAN 
 
Please complete this project plan before starting your project. 
 
1. Short Title of Audit: 
Outpatient endometrial biopsy results; a quality improvement project. 
 
2. Details of Audit Lead  
Audit Lead: 
Name: Islam Elkhateb 
Designation: Registrar  
Contact details: 
E-mail: islamtarekhamed@gmail.com 
Phone: 99780408 
 
3. Details of Audit Sponsor:  
Audit Sponsor: 
Name: Dr  
Designation: Consultant 
 
Name: Dr  
Designation: Head of department  
 
4. Date plan completed: 
27/10/2024 
 
5. Rationale and objectives of the Audit: 
 
Pipelle is the most commonly used outpatient endometrial biopsy device. 
Pipelle endometrial biopsy can diagnose 90% of endometrial cancer cases. 
It is one of the first line diagnostic procedure for women presenting with abnormal peri- and post-
menopausal vaginal bleeding.  
Insufficient samples are obtained in 5-23% of cases.  
In our hospital, a retrospective analysis of all outpatient endometrial samples sent to the histopathology 
department from April- to October 2024 study showed an insufficient sample percentage of 32%This 
maybe attributed to patients, equipment, and physicians factors. 
 
Our project aims to improve the endometrial biopsy results by Identifying these factors in our hospital 
setting, Implementing measures to modify them, and finally e-auditing the endometrial biopsy results 
after six months.  
 
6. Based on your audit rationale how would you classify this audit? 
This is an external audit   
(e.g. National audit) 
 
This is an internal audit  
(e.g arising from Trust objectives/ risks/ incidents / 
complaints/ NICE guidelines compliance etc) 
This a Division/Service priority  
   
(e.g. part of Divisional or Team Service improvement 
priorities) 
 
This is an individual clinician interest  
(e.g. personal interest, personal development or as 
part of an educational or training programme) 
 
7. Background and criteria that will be audited?  

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 Evidence: 
 
▪ Blumenthal PD, Berek JS. A Practical Guide to Office Gynecologic Procedures. Lippincott Williams & 
Wilkins; 2013 Apr 8. Chapter 14, Endometrial Biopsy; P92-98 
 
▪ Giuseppe Del Priore.Office-based endometrial sampling procedures. In: UpToDate, Connor RF (Ed), 
Wolters Kluwer. (Accessed on October 21, 2024.) 
 
▪ Williams PM, Gaddey HL. Endometrial biopsy: tips and pitfalls. American Family Physician. 2020 May 
1;101(9):551-6. 
 
Suggested criteria (proforma items): 
 
1. Place the patient in the dorsal lithotomy position. 
2. Perform a bimanual examination, paying particular attention to the size, shape, and orientation of the 
uterus. 
3. Insert a speculum and visualize the cervix. 
4. Cleaning the cervix with antiseptic solution (eg, povidone-iodine) is performed by some clinicians, but not 
all. Sterile preparation in patients who are allergic to iodine is discussed separately.  
5. If anesthesia is to be used, it is administered prior to any other manipulation. 
6. In many patients, an endometrial sampling device can be inserted without grasping the cervix with a 
tenaculum. Use of a tenaculum increases patient discomfort. 
7. A tenaculum should be used if the uterus is not close to axial in position. In such cases, place a 
tenaculum (with teeth in a horizontal position) on the anterior cervical lip and retract outwardly to 
straighten the cervicouterine angle. Straightening the uterine axis may reduce the risk of uterine 
perforation. If a tenaculum is required and a paracervical block has not been given, we may apply a local 
anesthetic (eg, 2% benzocaine gel or 20% benzocaine spray) to the intended site before placing the 
tenaculum. Directing the patient to cough while simultaneously applying the tenaculum may also decrease 
discomfort. Patients scheduled for sampling may be advised to take an NSAID prior to arriving at the 
clinic. 
8. Using steady and moderate pressure, slowly insert the sampling device through the cervical os and on to 
the uterine fundus. Stop when resistance is met. 
9. If the device will not pass through the cervix, attach a tenaculum (if not already in place), and use a series 
of small (1 to 4 mm) Hegar or similar dilators to gently dilate the canal. An Allis clamp rather than a single-
tooth tenaculum may offer some advantages (eg, less bleeding). 
10. Many devices are marked with centimeters, so the device can be used to measure the uterine depth. 
Average uterine length is 6 to 8 cm. 
11. Stabilize the sheath with one hand and pull the piston out as far as possible to create suction. 
12. Move the device tip along the endometrial surface using a corkscrew rotation combined with a repeating 
cephalic-caudal motion while maintaining suction. 
13. Remove the device when the entire cavity has been sampled. Expel the specimen into a formalin 
container. If there appears to be insufficient tissue for diagnosis, perform a second pass with the device. 
The same device may be used if it has not been contaminated; it should not have touched the formalin. 
14. Remove the tenaculum, if present. Most bleeding can be controlled with pressure via cotton swabs or a 
sponge stick. If bleeding persists, use ferric subsulfate (Monsel) solution or silver nitrate sticks to 
cauterize the site. 
 
Side effects and complications: 
1. The most common side effect of endometrial sampling is cramping, which subsides rapidly after the 
procedure is completed. Cramping tends to be more severe with the higher pressure suction devices than 
low-pressure devices because the former is more rigid, the suction is greater, and larger samples are 
removed. Many patients will experience light vaginal bleeding or spotting for several days following the 
procedure. 

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2. Vasovagal reactions are not uncommon during endometrial sampling. Such reactions can generally be 
prevented by allowing the patient to eat and drink before the procedure and by minimizing pain through 
use of analgesics and, if necessary, local anesthesia. The risk of uterine perforation is approximately 1 to 
2 per 1000 procedures. 
3. Rare complications include excessive uterine bleeding (especially with undiagnosed coagulopathies), 
uterine perforation (risk, 0.1 to 1.3 percent), pelvic infection, and bacteremia (including sepsis and 
endocarditis). 
 
Comtraindications: 
1. The only absolute contraindication to endometrial sampling is the presence of a viable and desired 
pregnancy 
2. A bleeding diathesis is a relative contraindication since bleeding may be excessive in such patients 
3. In the presence of acute vaginal, cervical, or pelvic infection, the procedure should be deferred, if 
possible, until the infection has been treated. This does not apply to clinical situations in which the 
indication for the biopsy is to evaluate for a subclinical infection or perform microbiologic and histologic 
studies. 
4. In rare instances, in which endometrial sampling needs to be performed in a patient with cervical cancer, 
an obstructing cervical lesion may be a relative contraindication in some patients due to increased risk of 
bleeding or uterine perforation. Imaging may obviate the need for endometrial sampling in this 
circumstance. 
5. Sampling can be performed with an intrauterine device in place. In our practice, we have done so without 
complications 
 
N.B.: 
▪ One approach to improving the tissue adequacy rate is by using a technique that combines a 
corkscrew twisting motion and uterine curettage. When using this method, the device is inserted to the 
fundus and then withdrawn to the lower uterine segment, alternating between a corkscrew twisting 
motion and the motion usually used to curette the еոԁοmetrium during a dilation and curettage (D&C). In 
a retrospective review with uniform pathology evaluation, use of a corkscrew twisting motion and uterine 
curettage yielded adequate tissue in 95 percent of cases, which was higher than the 77 percent success 
rate with a corkscrew technique alone 
▪ When using a suction device, do not let the sheath come outside of the external os or you will lose the 
negative pressure. If you do, simply expel the contents of the sheath into the formalin container or onto a 
sterile nonadhesive bandage (eg, Telfa), taking care not to contaminate the device, and reinsert the 
sheath. Multiple passes are sometimes needed to assure specimen adequacy. 
▪ Anesthesia: Office sampling procedures can usually be performed without significant pain. Discomfort 
can be minimized by reassuring the patient, explaining each step before doing it, and avoiding use of 
mechanical cervical dilators and/or a tenaculum, if possible. Some clinicians recommend an oral 
nonsteroidal anti-inflammatory drug (NSAID) 30 to 60 minutes prior to the procedure to decrease 
cramping 
▪ Cervical preparation and dilation: Cervical preparation or dilation is not required in many patients, 
particularly premenopausal parous patients. For those in whom it may be difficult to pass the sampling 
device without cervical dilation, misoprostol (200 to 400 mcg) orally, per vagina, or both may be given the 
night before the procedure 
▪ Endometrial brush: Several observational studies have compared endometrial sampling results from 
the endometrial brush with those of an endometrial suction sampling device. In a larger study, 526 pre- 
and postmenopausal patients were evaluated using both the Tao Brush and the Рiрelle. In the 
postmenopausal patients, endometrial sampling with the brush resulted in a significantly higher 
proportion of adequate endometrial samples compared with the suction device 
 
8. How will you implement changes and recommendations? 
▪ A proforma/ checklist maybe put in the procedures room and included with the endometrial 
biopsy histopathology request. This shall outline the precautionary measures and instructions, 
as well as the steps of endometrial biopsy procedure. 

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▪ The topic will be mentioned in the morning meeting.  
▪ The topic maybe covered and illustrated in one of the biweekly scientific meetings.  
▪ An emai/ message maybe sent to all teams on the OBGYN department group. 
 
9. Do the audit standards cover the practice of one or more professional groups? 
This is a Multi-disciplinary audit 
 
 
This is an Uni-disciplinary audit 
 
 
 
10. What data collection method will be used? 
Retrospective and concurrent data collection: endometrial biopsy results over the previous six months 
(April- September 2024) were extracted from the computer system and alaysed.  
 
After drawing receommendations and implementing changes, endometrial biopsy results over the next 
six months (November 2024- April 2025) will be monitored and audited.  
 
11. What is your sample size?  
Name of Service or Team and Division 
Interval sampling was the method used for sample size calculation of this audit, in which all results in 
the specified time periods (April- Septmeber 2024) and (November 2024- April 2025) were included.  
429 cases were available for the previous 6 months (April- September 2024). Twhich is more than the 
sample size required for any prevalence study assuming a 50% prevalence rate and an infinite 
population (n=384). 
 
12. What is your planned project timetable 
Project Activity 
Estimated Completion Date 
Date of completiomn of data collection, inputting, and 
analysis 
31/10/2024 
Proposed date for presentation of results and 
recommendations for the modification of practice 
4/11/2024 
Proposed date for start of implementation of modifications 
5/11/2024 
Proposed date for re-auditing the results 
May 2025 
 
13. How will service users or carers be involved in this audit? 
Service users are not be involved in this audit since they cannot modify/ control patient factors for 
insufficient endometrial biopsy results (example: nullipara, menopausal, ..  etc) 
Project lead:                                                                                            Project supervisor:   
Department head: 
 
 
 
 
 
 

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Outpatient endometrial sampling checklist 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name: 
 
Date: 
 
Before starting the procedure: 
 
1. Patient identity checked 
Informed consent obtained 
Equipment checked 
Proper lithotomy position and exposure. 
 
2. No contraindications: pregnancy, acute PID, bleeding diathesis, or obstructing cervical lesion 
 
3. Bimanual examination performed with non-sterile gloves, paying particular attention to the 
position of the cervix, and size and orientation of the uterus. 
 
During the procedure : 
 
4. Insert an appropriate-size speculum to visualize and center the cervix 
 
5. Optional: Cervix cleansed with antiseptic solution (especially if profuse vaginal discharge) 
 
6. Optional: Tenaculum applied in horizontal orientation (especially if cervix is very mobile or 
cervicouterine angle is very marked (uterus not axial), or dilation/ sounding is needed).  
An Allis/ Vulsellum is a better alrenative (less pain and bleeding) 
 
7. Pipelle slowly inroduced through the cervical os on to the uterine fundus using moderate and 
steady pressure. Stopped when resistance is met.  
Pipelle should be inserted 6-8cm to ensure that it is properly placed isnide the uterus 
 
8. Sheath stabilized the with one hand and piston pulled out as far as possible to create suction 
 
9. Device tip moved along the endometrial surface using a corkscrew (360’) rotation combined 
with a repeating cephalic-caudal motion while maintaining suction.  
Combining corkscrew motion with the motion usually used to curette the endometrium 
during D&C improves the sample adequancy 
 
10. Contents expelled into formalin container once the sheath comes out of the external os, taking 
care not to contaminate the device tip with non-setrile fomalin or container.  
 
11. Second or multiple passes done to ensure sample adequacy 
 
After the procedure: 
 
12. Check side effects: Vasovagal attacks are self-limiting, keep in supine. Painful uterine cramps 
usually resolve in 12 hours. Bleeding points in cervix controlled with cotton pressure or silver 
nitrate sticks.   
 
13. Patient counselled about red flags: come back if persistent pain, heavy vaginal bleeding, 
offensive vaginal discharge, fever, and chills. 
 

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(A) Endometrial biopsy catheter is inserted into the uterine fundus until resistance is felt. (B) The 
internal piston is fully withdrawn once the catheter is in the uterine cavity. (C) A 360-degree rolling or 
twirling motion is used as the catheter is moved between the uterine fundus and the internal os of the 
cervix

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