Evidence map›Paper›PMID 41387003›Full record

ArticleBMJ open2025

Michael Xie, John de Almeida, David Goldstein, Rosemary Martino, Yi Fan Liu, Brittany Allen, Wei Xu, Katrina Hueniken, Christopher Mkl Yao

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06965738 (Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06965738 phase2not yet recruitingnot on this map

Buccal Fat Applied to Transoral Robotic Lateral Oropharyngectomy Defects to Lessen Radical Tonsillectomy Pain (BOLT)

TypeinterventionalSponsorUniversity Health Network, TorontoRan2025 to 2027Enrolled40ConditionsTonsil Neoplasm, Oropharynx Neoplasm, Transoral Robotic SurgeryArmsBuccal fat reconstruction, No buccal fat reconstruction
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Michael XieDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-0583-2848
John de AlmeidaDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
David GoldsteinDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Rosemary MartinoDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Yi Fan LiuDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Brittany AllenDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Wei XuDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Katrina HuenikenDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Christopher Mkl YaoDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada christophermkl.yao@uhn.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTransoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction. METHODS AND ANALYSIS: This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/-) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model. ETHICS AND DISSEMINATION: The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals. TRIAL REGISTRATION NUMBER: NCT06965738.

Indexed as

Adipose TissuePlastic Surgery ProceduresPostoperative PainRobotic Surgical ProceduresTonsillar NeoplasmsTonsillectomyAdultClinical Trials, Phase II as TopicFemaleHumansMaleRandomized Controlled Trials as TopicSurgical FlapsHead & neck surgeryHead & neck tumoursPain management

Identifiers

PMID41387003
PMCPMC12706193

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.