Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedstar Health Research Institute

About this trial

This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids.

Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction.

Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy.

This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing minimally invasive laparoscopic or robotic-assisted uterine-preserving gynecologic surgery for removal of uterine fibroids (myomectomy) by a minimally invasive gynecologic surgeon at MedStar.

Disqualifiers

Patients with both fallopian tubes absent

Patients in whom it is not possible to place a uterine manipulator or catheter

Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery

Patients with allergy to methylene blue dye or G6PD deficiency

Trial design

Design model

Single group

Treatments tested in this trial

  • chromopertubation

    Procedure/Surgery

    Pre- and post-myomectomy chromopertubation procedure using dilute methylene blue dye solution for evaluation of tubal occlusion

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: ATOM study participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of tubal occlusion pre- and post-myomectomy

Frequency of tubal occlusion in patients with fibroids immediately prior to and after completion of myomectomy procedures. Spillage of methylene blue dye seen laparoscopically is indicative of tubal patency. Unilateral vs bilateral occlusion will be documented.

Time frame
Limited to the duration of each surgery

Secondary outcomes

1

Frequency of tubal occlusion compared to fibroid characteristics

Frequency of tubal occlusion as compared to fibroid(s): * FIGO classification * size * anatomic location

Time frame
Limited to the duration of each surgery
2

Change in tubal occlusion

Frequency of change in tubal occlusion comparing pre-myomectomy to post-myomectomy. Ex. occluded to patent or patent to occluded.

Time frame
Limited to the duration of each surgery

Other outcomes

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