Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for

Status Completed

Clinical Trial Summary

In a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray versus forced coagulation, will be compared. The primary outcome of the study is time to complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain, and postoperative bleeding complications.

Clinical Trial Description

Intraoperative bleeding during large loop excision of the transformation zone (LLETZ)-conization can be achieved by two modes of electrocoagulation, spray coagulation and forced coagulation. Spray coagulation is a superficial coagulation mode, whereas forced coagulation is a deep tissue coagulation mode. It is unknown, whether spray or forced coagulation is superior regarding intraoperative hemostasis and other outcome Parameters such as postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, comparing the two coagulation modes, spray coagulation and forced coagulation, The primary outcome of the study is time to complete hemostasis measured in seconds, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 10 step VAS scale, and postoperative bleeding complications, defined as necessity to intervene surgically for vaginal bleeding up to 14 days postoperatively. The study Population consists of women undergoing LLETZ-conization for histologically proven cervical dysplasia. The study hypothesis states that the difference in the mean time until complete hemostais will be at least 1/3 shorter in women randomized to spray coagulation. With a study Population of 120 women, this study has a power of >80% to detect a difference of 1/3 of the mean coagulation time until complete hemostais based on an anticipated mean time of 85 seconds. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02330471
Study type	Interventional
Source	Ruhr University of Bochum
Contact
Status	Completed
Phase	Phase 3
Start date	January 2014
Completion date	March 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01505920` - Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial	Phase 3
Completed	`NCT01014026` - Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention	Phase 3
Completed	`NCT00377845` - Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.	Phase 0
Completed	`NCT02910388` - LLETZ Under Direct Colposcopic Vision	N/A
Completed	`NCT00596258` - A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)	Phase 2
Completed	`NCT03763565` - Effectiveness of HPV Vaccine in Thai Adult Women
Completed	`NCT04415840` - Lugol's Solution in Addition to Acetic Acid During Colposcopy
Recruiting	`NCT04783805` - Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Completed	`NCT04326049` - LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy	N/A
Completed	`NCT02515162` - Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization	N/A
Completed	`NCT02486471` - Hemostatic Procedure After Biopsy of the Cervix	N/A
Completed	`NCT01405768` - Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)	Phase 2
Completed	`NCT00264732` - A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix	Phase 2/Phase 3
Completed	`NCT03296566` - The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams	N/A
Completed	`NCT02346227` - Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix	Phase 3
Completed	`NCT01035580` - Trial on Safety and Pharmacokinetics of Intravaginal Curcumin	Phase 1
Completed	`NCT01639820` - Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts	N/A
Completed	`NCT00285207` - Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix	Phase 2
Recruiting	`NCT05225493` - HIV Indicator Diseases in Hospital and Primary Care
Completed	`NCT01034358` - Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial — CONE-1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms