Antenatal Phenobarbital Therapy and Neonatal Outcome I: Effect on Intracranial Hemorrhage

PEDIATRICS ◽  
1996 ◽  
Vol 97 (5) ◽  
pp. 644-648 ◽  
Author(s):  
Seetha Shankaran ◽  
Eugene Cepeda ◽  
Geraldine Muran ◽  
Federico Mariona ◽  
Samuel Johnson ◽  
...  
Keyword(s):  
Treatment Group ◽  
Intracranial Hemorrhage ◽  
Preterm Labor ◽  
Controlled Trial ◽  
Control Group ◽  
Multiple Gestation ◽  
Treatment Groups ◽  
Multiple Gestations ◽  
Prospective Randomized Controlled Trial ◽  
Study Population

Objective. To evaluate the effect of antenatal phenobarbital (PB) therapy on neonatal intracranial hemorrhage (ICH) in preterm infants. Design. Prospective, randomized, controlled trial. Setting. Single institution study. Subjects and Interventions. Women in preterm labor (<35 weeks' gestation) were assigned to control and treatment groups. The treatment group received 10 mg/kg (maximum, 1000 mg) PB intravenously, followed by 100 mg orally daily, until delivery. Neonates did not receive PB after birth. Head sonograms were performed on days 3, 7, and 14 and at discharge. Hemorrhage was classified as mild, moderate, or severe by a single reader. Outcome Measures. Incidence of neonatal ICH in all infants, infants weighing less than 1250 g, and infants of multiple gestations. Results. The study population comprised 110 women, 60 in the control group and 50 in the PB group. Neonates in the control group (n = 74, including 10 pairs of twins and 2 sets of triplets) were comparable to those in the treatment group (n = 62, including 7 pairs of twins, 1 set of triplets, and 1 set of quadruplets) regarding birth weight, gestational age, and other clinical risk factors for ICH. There was a trend for the incidence of any grade of hemorrhage to be lower in the PB group (22% [14 of 62]) compared with the control group (35% [26 of 74]). Moderate and severe hemorrhages were significantly lower in the PB group (1.6% [1 of 62]) compared with the control group (9.4% [7 of 74]). Among infants weighing less than 1250 g, overall ICH was lower in the PB group (23% [6 of 261) compared with the control group (51% [18 of 35]). Among multiple-gestation infants, overall ICH was 4.7% (1 of 21) in the PB group, compared with 31% (8 of 26) in the control group. Conclusions. Antenatal PB therapy results in a significant decrease in moderate and severe ICH in infants born at less than 35 weeks' gestation. Antenatal PB therapy also resulted in a decrease in the incidence of all grades of ICH in infants weighing less than 1250 g and infants born of multiple gestations.

2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (6 Supple A) ◽  
pp. 3-12 ◽  
Author(s):  
David A. Crawford ◽  
Paul J. Duwelius ◽  
Michael A. Sneller ◽  
Michael J. Morris ◽  
Jason M. Hurst ◽  
...  
Keyword(s):  
Emergency Department ◽  
Treatment Group ◽  
Knee Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Emergency Department Visits ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Total Knee

Aims The purpose is to determine the non-inferiority of a smartphone-based exercise educational care management system after primary knee arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. Methods A multicentre prospective randomized controlled trial was conducted evaluating the use of a smartphone-based care management system for primary total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). Patients in the control group (n = 244) received the respective institution’s standard of care with formal physiotherapy. The treatment group (n = 208) were provided a smartwatch and smartphone application. Early outcomes assessed included 90-day knee range of movement, EuroQoL five-dimension five-level score, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) score, 30-day single leg stance (SLS) time, Time up and Go (TUG) time, and need for manipulation under anaesthesia (MUA). Results Overall, 90-day mean flexion was not significantly different between the control (121° (SD 11.7°)) and treatment groups (121o; p = 0.559); 90-day mean SLS was 22.7 seconds (SD 9.8) in controls and 24.3 seconds (SD 20.8) in treatment (p = 0.519); 90-day mean TUG times were 10.1 seconds (SD 4.8) in control and 9.3 seconds (SD 3.3) in treatment (p = 0.139). Mean KOOS JR scores were significantly different between control group (73.6 (SD 13.4)) and treatment group (70.4 (SD 12.6); p = 0.026). MUAs were performed in nine (3.7%) patients in the control group and four (1.9%) in the treatment group (p = 0.398). Physiotherapy was performed by 230 (94.4%) of control group and 123 (59.3%) of treatment group (p < 0.001). There were no significant differences between groups in postoperative urgent care visits, or readmissions within 90 days, with significantly fewer emergency department visits in the treatment group (16 (8.2%) vs five (2.5%), p = 0.014). Conclusion The use of the smartwatch/smartphone care platform demonstrated non-inferiority of clinically significant outcomes to traditional care models, while requiring significantly less postoperative physiotherapy and fewer emergency department visits. This platform could aid in decreasing postoperative costs, while improving patient engagement and communication with the healthcare team. Cite this article: Bone Joint J 2021;103-B(6 Supple A):3–12.

Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (7 Supple B) ◽  
pp. 91-97 ◽  
Author(s):  
David A. Crawford ◽  
Adolph V. Lombardi ◽  
Keith R. Berend ◽  
James I. Huddleston ◽  
Christopher L. Peters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Urgent Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Aims The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s standard of care. Those randomized to the treatment group (167) were provided with a smartwatch and smartphone application. PT use, THA complications, readmissions, emergency department/urgent care visits, and physician office visits were evaluated. Outcome scores include the Hip disability and Osteoarthritis Outcome Score (HOOS, JR), health-related quality-of-life EuroQol five-dimension five-level score (EQ-5D-5L), single leg stance (SLS) test, and the Timed Up and Go (TUG) test. Results The control group was significantly younger by a mean 3.0 years (SD 9.8 for control, 10.4 for treatment group; p = 0.007), but there were no significant differences between groups in BMI, sex, or preoperative diagnosis. Postoperative PT use was significantly lower in the treatment group (34%) than in the control group (55.4%; p = 0.001). There were no statistically significant differences in complications, readmissions, or outpatient visits. The 90-day outcomes showed no significant differences in mean hip flexion between controls (101° (SD 10.8)) and treatment (100° (SD 11.3); p = 0.507) groups. The HOOS, JR scores were not significantly different between control group (73 points (SD 13.8)) and treatment group (73.6 points (SD 13); p = 0.660). Mean 30-day SLS time was 22.9 seconds (SD 19.8) in the control group and 20.7 seconds (SD 19.5) in the treatment group (p = 0.342). Mean TUG time was 11.8 seconds (SD 5.1) for the control group and 11.9 (SD 5) seconds for the treatment group (p = 0.859). Conclusion The use of the smartphone care management system demonstrated similar early outcomes to those achieved using traditional care models, along with a significant decrease in PT use. Noninferiority was demonstrated with regard to complications, readmissions, and ED and urgent care visits. This technology allows patients to rehabilitate on a more flexible schedule and avoid unnecessary healthcare visits, as well as potentially reducing overall healthcare costs. Cite this article: Bone Joint J 2021;103-B(7 Supple B):91–97.

Effects of transcutaneous electrical acupuncture point stimulation on peripheral capillary oxygen saturation in elderly patients undergoing colonoscopy with sedation: a prospective randomized controlled trial

2020 ◽  
pp. 096452842096047
Author(s):  
Yongming Chen ◽  
Yin Gong ◽  
Xiaorong Huai ◽  
Xiyao Gu ◽  
Diansan Su ◽  
...  
Keyword(s):  
Treatment Group ◽  
Elderly Patients ◽  
Oxygen Saturation ◽  
Controlled Trial ◽  
Acupuncture Point ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Electrical Acupuncture ◽  
Registration Number ◽  
Blood Pressures

Introduction: This study investigated whether transcutaneous electrical acupuncture point stimulation (TEAS) at PC6 can reduce the proportion of elderly patients experiencing a drop of ⩾4% in peripheral capillary oxygen saturation (SpO2) while undergoing colonoscopy under sedation. Methods: A total of 32 elderly patients (aged ⩾ 65 years) scheduled for colonoscopy were randomly assigned in a 1:1 ratio to receive either real or sham TEAS (treatment or control groups, respectively). Each patient received oxygen (2 L/min) delivered routinely via nasal cannula. The treatment group was given TEAS at PC6 for 20 min at 2 Hz frequency and 6 mA intensity; the control group underwent the same procedures but with zero frequency/intensity. SpO2 and other physiological parameters were measured prior to sedation and colonoscopy (baseline) and at seven other timepoints through departure from recovery. Depth of anesthesia was measured using a Narcotrend monitor. Results: Significantly fewer patients in the treatment group experienced a ⩾4% decrease from baseline SpO2 (2/16) than patients in the control group (10/16; p = 0.004). The two groups were comparable with regard to respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, and heart rate. Conclusion: TEAS applied at PC6 with 2 Hz frequency was feasible and may be helpful in reducing the rate of hypoxia in elderly patients during colonoscopy. Trial registration number: NCT03775122 (ClinicalTrials.gov).

Antenatal Phenobarbital Therapy and Neonatal Outcome II: Neurodevelopmental Outcome at 36 Months

PEDIATRICS ◽  
1996 ◽  
Vol 97 (5) ◽  
pp. 649-652
Author(s):  
Seetha Shankaran ◽  
Eunice Woldt ◽  
Jay Nelson ◽  
Mary Bedard ◽  
Virginia Delaney-Black
Keyword(s):  
Growth Parameters ◽  
Controlled Trial ◽  
Neurodevelopmental Outcome ◽  
Physical Growth ◽  
Control Group ◽  
Neurodevelopmental Outcomes ◽  
Randomized Controlled ◽  
Multiple Gestations ◽  
Prospective Randomized Controlled Trial ◽  
Pb Exposure

Objective. To evaluate the effect of antenatal phenobarbital (PB) therapy on neurodevelopmental outcome at 36 months. Design. Prospective, randomized, controlled trial. Setting. Single-institution study. Subject and Interventions. Children born to women who participated in the study evaluating the effect of antenatal phenobarbital (PB) on neonatal intracranial hemorrhage were prospectively followed to 3 years of age. Outcome Measures. Physical growth, neurologic examinations, and developmental testing (McCarthy Scales of Children's Abilities). Comparisons between groups were made on all children and those born to multiple gestations. Results. Forty-one children born to women who received 10 mg/kg PB before delivery and 55 children in the control group were evaluated. Three children, all in the control group, had growth parameters (height, weight, and head circumference) below the fifth percentile. The McCarthy General Cognitive Index (standard, 100 ± 16) was 93 ± 20 in the PB group and 85 ± 18 in the control group. The subscores tended to be higher in the PB group than in the control group, with higher quantitative scores in the PB group (44 ± 11 vs 39 ± 8). Neurologic deficits were noted in 2 of 41 in the PB group and in 6 of 55 in the control group. Conclusions. Infants born to women who received antenatal PB therapy had similar neurodevelopmental outcomes as infants born to women who did not receive PB. No adverse effects of PB exposure were detected.

Efficacy of Vaginal and Oral Progesterone After Tocolytic Therapy in Threatened Preterm Labor: A 3-Arm Parallel- Group Randomized Controlled Trial

2021 ◽  
Vol 104 (5) ◽  
pp. 746-756
Keyword(s):  
Preterm Delivery ◽  
Preterm Labor ◽  
Controlled Trial ◽  
Latency Period ◽  
Pairwise Comparison ◽  
Control Group ◽  
Short Cervix ◽  
Treatment Groups ◽  
Vaginal Progesterone ◽  
Threatened Preterm Labor

Background: Progesterone has established roles in preventing preterm labor in women with history of spontaneous preterm labor and short cervix, but there is little evidence to support its use to prevent preterm delivery in women with threatened preterm labor. Objective: To evaluate clinical efficacy of oral and vaginal progesterone on prevention of preterm delivery before 34 and 37 weeks in threatened preterm labor. Materials and Methods: The present study was a 3-arm randomized control trial, 231 singleton pregnancies of 28- to 33-weeks-6-days who had threatened preterm labor were recruited and randomized to three groups,1) 200 mg/day vaginal micronized progesterone, 2) 30 mg/day oral dydrogesterone and 3) control group with no progesterone. All groups received identical standard treatment for threatened preterm labor. Comparison of primary outcomes, which is the preterm delivery before 34 and 37 weeks, across groups were performed using chi-square test. Secondary outcomes, which are latency period, cervical change, maternal morbidity, neonatal morbidity, and mortality, were also compared. Results: Proportion of preterm delivery before 34 weeks was not significantly different across the three treatment groups at 16.0%, 12.0%, and 5.2% in control, oral progesterone, and vaginal progesterone groups, respectively (p=0.098). Concerning pairwise comparison, vaginal progesterone was more efficacious in preventing preterm delivery before 34 weeks than the control group (p=0.030), while oral progesterone was similarly effective to the control group (p=0.638). Proportion of preterm delivery before 37 weeks was not significantly different across the three treatment groups at 41.3%, 45.3%, and 31.2% in control, oral, and vaginal progesterone groups, respectively (p=0.182). Latency period differed across three treatment groups with a median latency of 36.5, 42.0, and 43.0 days in control, oral, and vaginal progesterone groups, respectively (p=0.041). Changes in cervical length and Bishop scores were not different across treatment groups. Conclusion: Vaginal progesterone could prevent preterm delivery before 34 weeks and prolong latency period in women with threatened preterm labor. Keywords: Preterm labor, Progesterone efficacy, Threatened preterm labor, After tocolysis

scholarly journals Impact of Mother-to-Mother Support Groups in Promoting Exclusive Breastfeeding in a Low-Resource Rural Community in Kenya: A Randomized Controlled Trial

2020 ◽  
pp. 609-621
Author(s):  
Joseph Kobia M’Liria ◽  
Judith Kimiywe ◽  
Sophie Ochola
Keyword(s):  
Treatment Group ◽  
Support Groups ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Control Group ◽  
Community Based ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
National Rate ◽  
Breastfeeding Education

Breastfeeding is the single most effective intervention for growth, health, development and survival of infants. Exclusive breastfeeding (EBF) for 6 months alone can reduce under-five child mortality by up to 13%. Community-based strategies such as Mother-to-Mother Support Groups (MTMSGs) have improved the rates of EBF by increasing the length of maternal support before and after delivery. The rate of EBF in the study area was 18.6%, which was lower than national rate of 32% at the time of the study. Currently, the Kenyan national rate is 61% but with high regional variability. This study was designed to assess the impact of community-based MTMSGs with or without income generating activities in promoting EBF in low socio-economic rural setting in Kenya. This was a cluster randomized controlled trial in which 3 health centres in Igembe South Sub-County in Meru County, Kenya were randomly allocated to three study groups, on a ratio of 1:1:1; to two treatment groups and a control group. The target population was pregnant mothers in their third trimester (33-37 weeks) and registered at ante-natal clinics in any of the 3 health centres. Total sample size was 249. Mothers in the first treatment group received breastfeeding education and support during seven monthly meetings by trained breastfeeding peer educators. Mothers in the second treatment group received breastfeeding education and support at the same frequency as those in first group in addition to conducting income generating activities facilitated by the research team. Mothers in the control group received no breastfeeding education. Infant feeding practices were determined based on 24–hour recall. Data was collected on monthly basis for 6 months postpartum by interviewers blinded to the study hypotheses. The primary outcome was EBF prevalence at six months while secondary outcome was cumulative EBF at six months. Mothers in the first and second treatment groups were two times more likely to exclusively breastfed at 6 months compared to mothers in the control group [RR=2.42;CI 1.36-4.28;(p=0.004] and [RR=1.89;CI 1.02-3.49;(p=0.033)] respectively. There was no significant difference in the EBF rates at 6 months in the 2 treatment groups. Median duration of cumulative EBF for the control group was significantly lower at 0.7 months compared with first treatment group at 2.8 months (p<0.001) and second treatment group at 3.4 months (p<0.001). Mother-to-mother support groups is an effective strategy in promoting exclusive breastfeeding in low socio-economic rural settings and should therefore be strengthened in Kenya and similar circumstances.

scholarly journals Effect of Cooling Irrigating Saline in Tongue Base Ablation in Obstructive Sleep Apnea

OTO Open ◽  
2021 ◽  
Vol 5 (1) ◽  
pp. 2473974X2198959
Author(s):  
Ahmed Yassin Bahgat
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Controlled Trial ◽  
Tongue Base ◽  
Control Group ◽  
University Hospitals ◽  
Energy Field ◽  
Obstructive Sleep ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Objective Plasma is formed by creating a high-density energy field within an electrically conductive fluid such as saline. Sometimes ablated bits of tissue get stuck between the electrodes of the wand, obstructing the suction channel. The purpose of this study is to investigate the effect of cooling the irrigating saline during ablation of the hypertrophied tongue base in patients with obstructive sleep apnea. Study Design Prospective randomized controlled trial. Setting An otorhinolaryngology department in Main University hospitals. Methods Sixty adult patients with obstructive sleep apnea and tongue base hypertrophy underwent tongue base ablation surgery. Patients were randomly divided into 2 groups of 30 patients each: cooled saline and room temperature saline. The Coblation wand used was the EVac 70 Xtra HP (Smith & Nephew). Results In this study, a significant difference in operative time (mean ± SD) was seen between groups: 21.2 ± 5.5 minutes in the cold group and 47 ± 9.5 minutes in the control group ( P = .001). The wands in the cold group did not obstruct, while all the wands in the control group were obstructed by tissue clogs with variable degrees, hence wasting more time to clean the wands’ tips. Conclusion Cooling the irrigating saline overcame the problem of wand clogs, and the wand tip did not occlude at all during the procedures, thus saving time lost in wand cleaning and demonstrating a faster and safer surgical procedure. Further studies are needed to identify the hemostatic effect of the cooled saline over the regular one.

scholarly journals Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  
Keyword(s):  
Thermal Insulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Warming Blanket ◽  
Group A ◽  
Insulation Effect ◽  
Group B

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.

scholarly journals The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jae Yen Song ◽  
Hoon Choi ◽  
Minsuk Chae ◽  
Jemin Ko ◽  
Young Eun Moon
Keyword(s):  
General Anesthesia ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Postoperative Outcomes ◽  
Control Group ◽  
Quality Of Recovery ◽  
Gynecological Laparoscopy ◽  
Prospective Randomized Controlled Trial

Abstract Background Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods The participants (n = 78) will be allocated to one of the two groups; the study group will receive bolus and infusion of dexmedetomidine and lidocaine, and the control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in the two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, and opioid-related side effects will be assessed. Additionally, an ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during the study period. Discussion This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA. Trial registration ClinicalTrials.gov NCT04409964. Registered on 28 May 2020

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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