How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?

Browse trials for

• Uterine Cervical Dysplasia 356
• Constriction, Pathologic 1,117

Keywords

• Cervical Intraepithelial Neoplasia
• stenosis
• cervix
• medical device
• inventories
• Uterine Cervix
• Intrauterine Devices
• intrauterine
• conization
• loop electrosurgical excision

Uterine Cervical Dysplasia

356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.

This study's enrollment of 265 is above the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.

Lead sponsor

Barretos Cancer Hospital is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Study arms

• Experimental
  DUDA device

  The number of patients to be recruited in this arm will be 145. Note: The first twenty-five patients who will be included in the study will be allocated in the intervention arm to safety analysis (phase 1); after that all eligible candidates will be randomized 1:1 (phase 2). Procedure: Loop Electrosurgical Excision Procedure (LEEP) followed by implantation of the device called DUDA (plastic device developed in barretos cancer hospital that will be placed after conization. It has 2.5 cm in length and 5mm in diameter and remains within the endocervical canal for 30 days and is set at 4 points with nonabsorbable sutures in the ectocervix.)

  Device: DUDA device · Procedure: LEEP

• Active comparator
  Control group

  The number of patients to be recruited in this arm will be 120. Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device

  Procedure: LEEP

Interventions

• DeviceDUDA device

  Insertion DUDA device

• ProcedureLEEP

  Loop Electrosurgical Excision Procedure

Primary outcomes

1. Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5)

   The main safety events to be considered in this analysis are vaginal bleeding and uterine infection. The device is considered unsafe and consequently disrupted the study if a two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5 related to the procedure/device happens during the phase 1.

   Time frame: 3 months

2. Cervical stenosis

   Stenosis of the endocervical canal (early and late) will be assessed by clinical information and physical examination at each visit to the hospital after surgery. The participant will be asked about the menstrual flow and dysmenorrhea during history taking. On physical examination, after the visualization of the cervix through the speculum examination, the doctor will check the channel permeability introducing a hysterometer through it. The difficulty of introducing the hysterometer 2.5mm the channel will be scored according to the following scale: Possible passage of hysterometer? () No difficulty () Little difficult, however possible passage of hysterometer () Unable to pass

   Time frame: 6 months

Secondary outcomes

1. Pain Scales

   The quality of life will be evaluated through questionnaires by the Functional Assessment of Cancer Therapy - Cervix Cancer (FACT-Cx) and the universal pain assessment tools that include international scale and pain visual analogue (EVA), numerical visual pain scale (EVN) and faces pain scales (EF).

   Time frame: 6 months

2. Complications

   It will be evaluated during the following returns and described as any event related directly to the use of DUDA device as metrorrhagia and uterine infection.

   Time frame: 30 days

3. View of the squamo-columnar junction (SCJ) of the cervix

   It will be assessed during the examination of colposcopy

   Time frame: 6 months