A Single Center Randomized Controlled Trial Assessing Pain and Quality of Life Following Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2021-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to help us to better understand the effects of two different types of surgical techniques on pain and quality of life in patients with precancerous lesions or early stage mouth cancers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

NCT06282237

Sarcoma

RECRUITING

Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity

NCT00193765

Oral Cancer

UNKNOWN NA

Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma

NCT01334320

Oral Squamous Cell Carcinoma

UNKNOWN NA

Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx

NCT00918762

Head and Neck Cancer Perioperative/Postoperative Complications Precancerous Condition

COMPLETED PHASE1

Collagen Matrix in Oral Cancer Surgery

NCT07337122

Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer Oropharynx Squamous Cell Carcinoma Oropharynx Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flexible Fiber-based CO2 Laser

In the CO2 excised group, the resection will be performed at 15W, at a distance of 1cm from the tissue. Here too, if required, the bipolar will be used to achieve hemostasis The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Group Type EXPERIMENTAL

Flexible Fiber-based CO2 Laser, Quality of Life forms

Intervention Type OTHER

. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

electrocautery resection

In the electrocautery excised group, the cut and coagulation modes used will be each at 25 Malis power setting. First, cut mode will be used to mark out the lesion. Subsequently, coagulation mode will be used for excision. Bipolar cautery will then be used at 25 Malis for hemostasis. The study will focus on post operative pain and quality of life outcomes for both surgical interventions.

Group Type EXPERIMENTAL

electrocautery resection and quality of life forms

Intervention Type OTHER

Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flexible Fiber-based CO2 Laser, Quality of Life forms

. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Intervention Type OTHER

electrocautery resection and quality of life forms

Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Biopsy proven diagnosis or clinical diagnosis of any benign oral cavity lesion. Pre-surgical biopsy will not be required if lesion is suspected to be benign.
* Biopsy proven diagnosis or clinical diagnosis of premalignant oral cavity lesions (leukoplakia, erythroplakia, lichen planus, dysplasia)Pre-surgical biopsy will not be required if lesion is suspected to be benign.
* Biopsy proven diagnosis of small superficial oral cavity SCC (stage T1N0) requiring resection without the need for neck dissection.
* All pathology will be reviewed at MSK to confirm diagnosis.
* The lesion plus the resection margin should not exceed 4.0 cm circumferentially.
* Planned to undergo surgical treatment by resection without flap reconstruction and without neck dissection.
* All patients age 18 years of age and older.
* Karnofsky performance score over 60.

Patients on blood thinners (aspirin or Coumadin) will be asked to stop medications 7 days prior to surgery. In the case of Coumadin, patients are switched to lovenox 7 days prior to surgery and this is stopped the day before surgery. Following surgery aspirin or Coumadin are recommenced 48 hours postop.

Exclusion Criteria

* Patients with previous Head and Neck radiation
* Pregnant or lactating female patients.
* Patients with oral cavity squamous cell cancer requiring neck dissection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No