Dataset Information

Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study.

ABSTRACT: Introduction: Alignment of the uterine cervix with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently available instruments are traumatic tenacula, which can cause pain and bleeding and represent an obstacle for certain patients to pursue their medical follow-up. A novel investigational cervical vacuum tenaculum, enables atraumatic traction of the cervix using a semi-circular suction pad, designed to conform to the anatomical shape of the external cervical os. Suction is generated by manually pulling out a sliding tube in a vacuum chamber. Methods: We performed a single arm non-comparative pilot study to assess the safety and efficacy of the cervical vacuum tenaculum in 13 women receiving an IUD. Data on procedural efficacy, safety, patient-reported pain scores at specific time points during IUD insertion procedure and patient satisfaction were collected prospectively. Results: Insertion of IUD was successful with use of the study device in 7 of the 13 enrolled patients (54%). No bleeding or only limited ecchymosis were caused by the device. No adverse events were reported. Participants reported very little pain (mean Visual Analog Scale <10) when applying the device. Participants who achieved IUD insertion with the device reported strong overall satisfaction with the procedure. Conclusions: The suction-based atraumatic tenaculum can be used to manipulate the cervix during IUD insertion with satisfactory efficacy and safety. The results of this pilot study support further studies of this device in larger populations comparing with standard single-tooth tenaculum. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04441333.

SUBMITTER: Legardeur H

PROVIDER: S-EPMC8732360 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundCervical radiculopathy is a relatively common and disabling condition involving local pain in the neck region and pain that radiates into the upper limb. Recent data suggest that cervical traction may effectively reduce disability and pain, with a dose-response relationship. The main aim of this study was therefore to evaluate the mid-term effect of an intensive cervical traction protocol for patients with cervical radiculopathy on disability, and to compare the effects with those reported by non-intensive protocols in the literature.MethodsWe conducted a prospective open observational study of 36 patients referred by their general practitioner for symptoms suggestive of cervical radiculopathy. All patients underwent the same treatment: a 30-minute cervical traction protocol, twice a day, for five consecutive days. The main objective was the evaluation of disability at 3 months. We evaluated at baseline (D1), the end of the protocol (D5) and at mid-term (M3) disability, cervical pain, radiating pain, pain on motor imagery, presence of neuropathic pain and medication consumption. The primary outcome was the proportion of patients for whom the Neck Disability Index improved by more than the minimum clinically important difference of 7 points by M3.ResultsThirty-six patients were included in this study. The Neck Disability Index improved by more than the minimum clinically important difference in 48.3% at M3. Mean Neck Disability Index (p < .001), mean cervical VAS (p < .001), mean radiating VAS (p < .001), and mean VAS for imagined lateral flexion and rotation (p < .002) improved significantly from D1 to D5 and from D1 to M3. Consumption of medication reduced at each time point. The proportion of patients with neuropathic pain reduced from 61.1% at D1 to 33.3% at D5 and 48.3% at M3.ConclusionDisability reduced by more than the minimum clinically important difference in almost half of the participants following the intensive traction protocol. These results are encouraging and suggest that this complex condition can be treated with relatively simple methods.

Project description:Background Currently, we found that double reverse traction repositor (DRTR) is a treatment with operation convenience and fast in our clinical work. However, the clinical efficacy and safety of DRTR in the reduction of unstable intertrochanteric fractures in elderly patients remain unknown. Therefore, the study aimed to compare the clinical efficacy and safety of DRTR and traction table (TT) in the reduction of unstable intertrochanteric fractures in elderly patients. Methods From October 2018 to December 2020, the elderly patients with unstable intertrochanteric fractures were reviewed. 22 patients treated with TT and 20 patients treated with DRTR met the inclusion criteria of this study, and baseline clinical characteristics were recorded. The reduction time, operation time, incision length and intraoperative blood loss were reviewed. The safety outcome was assessed by postoperative complications, and the efficacy outcomes were evaluated by the fracture healing time based on the radiographs conducted at each follow-up (1, 3, 6, 12 months after surgery) and hip function (hip flexion, Harris Hip Score) at the final follow-up (12 months after surgery). Results There were no significant differences in terms of demographics and fracture characteristics of cases enrolled. In DRTR group, the average intraoperative reduction time [(34.8±7.6) min] and the average operation time [(87.1±12.2) min] were superior to those [(56.6±9.3); (123.1±15.0) min] in TT group (P<0.0001). However, there were no statistical significance in terms of the average incision lengths [(6.4±0.9) vs. (6.8±1.1) cm; P=0.1619], , the average intraoperative blood loss [(152.6±22.9) vs. (146.8±20.7) mL; P=0.3941], the average fracture healing times [(13.8±1.5) vs. (14.4±1.8) weeks; P=0.2350] and the average Harris hip score a year after operation [(84.4±6.6) vs. (82.7±7.2); P=0.4496] between the two groups. One patient in TT group experienced lower extremity intermuscular venous thrombosis postoperatively. No other operation-related complications were observed postoperatively nor during follow-up. Conclusions Minimally invasive reduction with DRTR in unstable intertrochanteric fractures could effectively shorten the intraoperative reduction time and operation time in this study. Therefore, minimally invasive reduction with DRTR might be a good choice for intertrochanteric reduction of unstable intertrochanteric fractures.

Dataset Information

Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets