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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
| Connecticut Children's Medical Center | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Children's Hospital Los Angeles |
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Purpose of the Study:
This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal.
Who Is in the Study:
Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with.
Main Questions the Study Wants to Answer:
Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital?
What Will Happen:
Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drain | Active Comparator | During surgery, at the completion of the Sistrunk procedure, participants will have a suction drain placed. The drain will be removed later based on standard criteria prior to discharge from the hospital. |
|
| No Drain | Active Comparator | At the completion of the Sistrunk procedure, participants will not have a suction drain placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-surgical drain | Procedure | During surgery, at the completion of the Sistrunk procedure, participants in the drain cohort will have a suction drain placed, which will be removed based on standard criteria prior to discharge from the hospital. Wound care following drain removal will be standardized, with instructions for patients to allow the area to heal naturally and to follow a regimen of cleaning and applying topical antibiotic ointment for several days. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Hematoma | The occurrence of hematoma will be assessed. A hematoma is defined as a localized collection of blood at the surgical site that is clinically significant and requires management beyond observation (e.g., drainage, surgical evacuation). A single value per participant is derived as yes (hematoma present) or no (hematoma absent). A "yes" indicates a hematoma occurred; a "no" indicates no hematoma occurred. | 30 days post-procedure |
| Occurrence of Seroma | The occurrence of seroma will be assessed. A seroma is defined as a localized collection of serous fluid at the surgical site that is clinically significant and requires intervention (e.g., aspiration or drainage). A single value per participant is derived as yes (seroma present) or no (seroma absent). A "yes" indicates a seroma occurred; a "no" indicates no seroma occurred. | 30 days post-procedure |
| Occurrence of Surgical Site Infection (SSI) | The occurrence of surgical site infection will be assessed. An SSI is defined as an infection at the surgical site requiring treatment (e.g., antibiotics, wound drainage). A single value per participant is derived as yes (infection present) or no (infection absent). A "yes" indicates an infection occurred; a "no" indicates no infection occurred. | 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Return to Operating Room (OR) or Procedural Intervention | The need for any surgical or procedural intervention related to the Sistrunk procedure will be recorded. A single value per participant is derived as the presence (yes) or absence (no) of an intervention. A "yes" indicates the participant required a return to the OR or procedure; a "no" indicates no intervention was required. | 30 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Connecticut Children's |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33427321 | Background | Brooks JA, Cunningham MJ, Hughes AL, Kawai K, Dombrowski ND, Adil E. Postoperative Disposition Following Pediatric Sistrunk Procedures: A National Database Query. Laryngoscope. 2021 Jul;131(7):E2352-E2355. doi: 10.1002/lary.29331. Epub 2021 Jan 11. | |
| 26491480 | Background | Qureshi TA, Suhail A, Zaidi SS, Siddiq W. Is There Any Benefit of Drain Placement on Postoperative Complications in Patients Undergoing the Sistrunk Procedure? Int Arch Otorhinolaryngol. 2015 Oct;19(4):331-5. doi: 10.1055/s-0035-1549156. Epub 2015 Mar 27. |
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| ID | Term |
|---|---|
| D013955 | Thyroglossal Cyst |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| OTHER |
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| No post-surgical drain | Procedure | Patients will be recovered in SOC manner from Sistrunk surgery without drain placement |
|
| Hospital Readmission | Any unplanned hospital readmission lasting greater than 23 hours after initial discharge will be recorded. A single value per participant is derived as yes (readmitted) or no (not readmitted). A "yes" indicates a readmission occurred; a "no" indicates no readmission occurred. | 30 days post-procedure |
| Hospital Length of Stay | Hospital length of stay will be measured in total number of days admitted for the index hospitalization. A single value per participant is derived by counting the number of calendar days from admission to discharge. Higher numbers indicate longer hospitalization; lower numbers indicate shorter hospitalization. | 30 days post-procedure |
| Need for Antibiotics | Any prescription of antibiotics specifically related to wound healing will be recorded. A single value per participant is derived as yes (antibiotics prescribed) or no (not prescribed). A "yes" indicates antibiotics were required; a "no" indicates antibiotics were not required. | 30 days post-procedure |
| Hartford |
| Connecticut |
| 06107 |
| United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| 24888796 | Background | Hong P. Is drain placement necessary in pediatric patients who undergo the Sistrunk procedure? Am J Otolaryngol. 2014 Sep-Oct;35(5):628-30. doi: 10.1016/j.amjoto.2014.04.005. Epub 2014 May 4. |
| 31494373 | Background | Brooks JA, Cunningham MJ, Koempel JA, Kawai K, Huang JK, Weitzman RE, Osterbauer B, Hughes AL. To drain or not to drain following a Sistrunk procedure: A dual institutional experience. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109645. doi: 10.1016/j.ijporl.2019.109645. Epub 2019 Aug 19. |
| 2765833 | Background | Athow AC, Fagg NL, Drake DP. Management of thyroglossal cysts in children. Br J Surg. 1989 Aug;76(8):811-4. doi: 10.1002/bjs.1800760815. |