A randomized controlled trial comparing everting sutures with everting sutures and a lateral tarsal strip for involutional entropion. A randomized comparison of suturing techniques for episiotomy and laceration repair after spontaneous vaginal birth. A randomized clinical trial of the success rates of bilamellar tarsal rotation and tarsotomy for upper eyelid trachomatous trichiasis. A randomized controlled trial of alleviated positioning after small macular hole surgery. A controlled trial of surgery for trachomatous trichiasis of the upper lid. Comparative study of leg wound skin closure in coronary artery bypass graft operations. A clinical trial investigating the possible effect of the supine cervical rotatory manipulation and the supine lateral break manipulation in the treatment of mechanical neck pain: a pilot study. The effect of voluntary trunk rotation and half-field eye-patching for patients with unilateral neglect in stroke: a randomized controlled trial. A trial of surgery for trichiasis of the upper lid from trachoma.
To determine whether there is a statistically significant difference in the surgical outcome of everting sutures (ES) alone versus everting sutures with a lateral tarsal strip (ES+LTS) in the treatment of involutional entropion.
                Prospective randomized comparative trial.
                Sixty-three patients with primary involutional lower eyelid entropion were enrolled in the study. The age range was 54 to 94 years, with a mean age of 77 years. Baseline characteristics of the comparative groups were similar.
                Patients requiring primary surgical repair for involutional entropion were selected, and those providing informed consent were randomized for surgery. Thirty-six patients were randomized to ES alone, and 27 patients were randomized to ES+LTS. Patients were evaluated at 3 weeks and 6, 12, and 18 months postoperatively.
                Successful surgery was defined as a normal eyelid position at rest and inability to induce entropion on tetracaine provocation testing at or before the 18-month follow-up visit.
                Eight patients were lost to follow-up (7 had ES alone). Of the 55 patients with complete follow-up data, there were 6 failed procedures in the patients who underwent ES alone and no failed procedures in the patients who underwent ES+LTS (P = 0.02).
                These data provide strong evidence that success rates at 18 months are higher in patients treated with ES+LTS procedure compared with ES alone.
                Copyright (c) 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. To compare the continuous knotless technique of perineal repair with the interrupted method after spontaneous vaginal birth
                A randomized controlled trial.
                Canadian Task Force Classification I.
                This study was undertaken in a university hospital with more than 2200 deliveries per year. The static population of this district includes a wide range of socioeconomic classes and is predominately white.
                From May 1 to November 19, 2003, 214 primiparous women with a second-degree perineal tear or episiotomy were randomly allocated to either the continuous knotless technique (CKT; n=107) or the interrupted technique (IT; n=107) suturing method.
                The interrupted technique (IT) involves placing 3 layers of sutures whereas the continuous knotless technique (CKT) involves reapproximating vaginal trauma, perineal muscles, and skin with a loose, continuous, nonlocking technique.
                The primary outcomes of the study were perineal pain (evaluated by visual analogue scale) at 48 hours and day 10 and dyspareunia 3 months after delivery. Secondary outcomes included suture removal, wound dehiscence, analgesia use up to 48 hours, and satisfaction with repair established at 3 and 12 months after childbirth. At day 10, 19 women had dropped out of the study. Significantly fewer women reported pain at 10 days with the CKT than with the IT (32.3% vs 60.4%; p<.001). Analgesia use up to 48 hours postpartum was less in the CKT group than in the IT group (33.6% vs 54.2%; p<.05). No difference was found in superficial dyspareunia at 3 months for the CKT versus the IT group.
                The use of a continuous knotless technique for perineal repair is associated with less short-term pain than techniques with interrupted sutures. A randomized clinical trial study was conducted to compare the success rates of two surgical methods: Bilamellar Tarsal Rotation (BTR) and Tarsotomy (Transverse Tarsotomy and lid margin Rotation = TTR) for trachomatous trichiasis of the upper lid; where success was defined as no lash/eyeball contact in all positions of gaze, complete lid closure, no under or over correction. The study was conducted at Minellik II Hospital, Addis Ababa. Two hundred fifty six upper eyelids of 153 patients with entropion/trichiasis related to trachoma were enrolled in the two groups. Patients were randomly allocated for the BTR (124) and TTR (132) procedures. Out of these, 237 (92.6%) came for the third month follow-up. One hundred fifteen (48.5%) lids underwent BTR and the remaining 122 (51.5%) underwent TTR. In total, from 141 patients who came for the last follow up, 109 (77.3%) were females. BTR procedure was found to be successful in 25 (86.2%) of the eyelids with minor trichiasis and 74 (86.0%) of those with major trichiasis; the difference between patients who had had minor and major trichiasis (X2 = 0.08, P = 0.772) was not statistically significant. TTR was successful in 39 (95.1%) of the eyelids with minor trichiasis and 68 (84.0%) of those with major trichiasis, again no statistically significant difference was observed for minor and major trichiasis (X2 = 3.15, P = 0.379). There was no statistically significant difference in recurrence between BTR and TTR (X2 = 0.14, P = 0.711). Complications such as lid-notching, pyogenic granuloma, etc. were observed more in BTR than in TTR and this was statistically significant (X2 = 9.54, P = 0.002). In conclusion, the results show that TTR is equally successful in minor and major trichiasis and has fewer complications than BTR at three months of follow-up. To establish whether the success rate of surgery for small idiopathic macular holes (diameter, ≤ 400 μm) is significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position.
                Randomized, controlled, parallel-assignment, open-label, interventional, multicenter clinical trial.
                Sixty-nine patients from 6 specialized vitreoretinal units, randomized into 2 parallel groups and followed up after surgery for 3 months.
                All patients underwent pars plana vitrectomy, peeling of any epiretinal membrane, and 17% C₂F₆ gas filling. Patients then were advised randomly to observe either strict facedown positioning for 22 of 24 hours or simply to avoid the supine position for 10 days.
                The primary outcome measure was the rate of anatomic closure 3 months after surgery. Main secondary measurements included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, progression of cataract, and frequency of complications.
                The mean size of macular holes was approximately 300 μm in both groups. Closure rates were more than 90% in both groups: 32 (91.4%) of 34 eyes in the alleviated positioning group versus 32 (94.1%) of 35 eyes in the facedown positioning group (lower margin of 95% confidence interval of difference, -14.88%). The ETDRS scores at 3 months increased in both groups by 10.23 ± 14.64 and 10.52 ± 14.54 letters, respectively. Progression of cataract and the rate of other complications were not significantly different in the 2 groups.
                The success rate of surgery for idiopathic macular holes of 400 μm or smaller is not significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. These macular holes can be treated by streamlined surgery, that is, with no internal limiting membrane peeling and no facedown positioning (only avoidance of the supine position) with a closure rate of more than 90% and a mean gain in visual acuity of more than 2 ETDRS lines at 3 months.
                Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. The effectiveness of commonly used procedures to correct trachomatous trichiasis of the upper lid was examined in a clinical trial in Oman. Lids were graded as having minor trichiasis (five or fewer lashes), major trichiasis (more than five lashes), and defective lid closure. Randomly allocated surgery specific for lid grade was completed in 384 lids, of which 369 (96%) were followed up once or twice approximately 9 and 21 months after surgery. The definition of operative success included no evidence of trichiasis and complete lid closure. Tarsal rotation was the most effective operation and was successful in 80% of cases of minor trichiasis, compared with success rates of 29% for electrolysis and 18% for cryoablation. Tarsal rotation was successful in 77% of cases of major trichiasis, compared with a 41% success rate for tarsal advance and rotation. Surgery for major trichiasis produced a significant improvement in visual acuity in operated vs nonoperated fellow eyes in a regression model incorporating the between-eyes correlation of visual acuity. A prospective randomised study of four different methods of leg wound skin closure after removal of the long saphenous vein was carried out in 113 patients undergoing coronary artery bypass grafting. These methods were: (1) continuous nylon vertical mattress suture (27 patients); (2) continuous subcuticular absorbable (Dexon) suture (29 patients); (3) metal skin staples (Autosuture) (27 patients); and (4) adhesive sutureless skin closure ("Op-site") (30 patients). All wounds were examined by two independent observers at five, 10, and 45 days after operation. At five days, inflammation, extent of oedema, discharge, and infection were assessed. At 10 days attention was paid to the state of wound healing and at 45 days to the final cosmetic appearance. The use of continuous subcuticular suture resulted in significantly less discharge than did the use of metal staples, nylon vertical mattress suture, or Op-site. The incidence of established wound infection was 4.5% overall, with no infection in the wounds closed with Dexon. Assessment of the healing process showed subcuticular Dexon to be more effective than metal staples or vertical mattress nylon suture. The final cosmetic result showed continuous subcuticular suture to be superior to nylon vertical mattress suture and skin staples but as effective as Op-site sutureless skin closure. To evaluate the possible effect of the supine cervical rotary manipulation and the supine lateral break manipulation in the treatment of mechanical neck pain, according to subjective and objective clinical findings.
                Delivering a supine lateral break manipulation to the ipsilateral side of an inflamed facet joint(s) that exhibits a lateral flexion fixation may result in pain and/or discomfort to the patient. Thus the proposed alternative is a supine cervical rotary manipulation delivered on the ipsilateral side or a supine lateral break manipulation delivered on the contralateral side of the relevant joint(s).
                Randomized, comparative clinical trial.
                Two groups of 15 subjects diagnosed with mechanical neck pain.
                The diagnosis of mechanical neck pain and the identification of lateral flexion fixations in the cervical spine were made with conventional clinical evaluation, including motion palpation. Group A received a cervical rotary manipulation(s) on the ipsilateral side of the lateral flexion fixation(s), while group B received a supine lateral break manipulation(s) on the contralateral side of the lateral flexion fixation(s). Subjects received a maximum of 10 treatments over a 4-week treatment period. Outcome Measures: Both treatment groups were assessed with subjective (Numerical Pain Rating Scale 101, McGill Short-Form Pain Questionnaire and the Canadian Memorial Chiropractic College Neck Disability Index) and objective (cervical range of motion goniometer and algometer) measurement parameters at the initial consultation (before any treatment), the final consultation, and at a 1-month follow-up consultation. Statistical analysis was conducted at a 95% confidence level (alpha =.05) with the non-parametric 2-tailed Wilcoxon signed ranks test, the Mann-Whitney U test, and descriptive statistics. Two-tailed power analysis was conducted after the fact, where a confidence level of 80% (beta =.20) was considered satisfactory.
                Intragroup analysis indicated a significant difference between the initial consultation data and the final consultation data for the subjective data, indicating an effect. Analysis of the objective data did not reveal any significant difference. Intergroup analysis did not reveal any significant difference between the 2 groups when comparing the data of the initial consultation and the final consultation, indicating that both treatments had a similar or equal effect. Power analysis was not satisfactory for most data, indicating the possibility of many Type II errors.
                Statistically, the results suggested that both treatments had an effect but that neither group showed a benefit over the other. However, because of the unsatisfactory power of the study, conclusions are to be drawn with caution. Clinical significance supported the statistical outcomes where it was suggested that both treatments had an effect and that neither treatment had a greater effect. A larger sample size and the inclusion of a placebo group is recommended to reveal true treatment outcomes and trends. To investigate the effectiveness of voluntary trunk rotation and half-field eye-patching to treat patients with unilateral neglect in stroke.
                Pre-post, day 60 follow-up, single-blinded randomized controlled trial.
                Single-centre inpatient rehabilitation hospital.
                Sixty subacute patients with right hemisphere stroke having unilateral neglect within eight weeks post stroke consented to participate between November 2003 and July 2005. They were randomly assigned to three comparison groups.
                Nineteen patients received daily experimental training in voluntary trunk rotation (TR) for 1 hour five times a week for 30 days. Twenty patients received the same kind of treatment together with half-field eye-patching (TR + EP). Fifteen patients in the control group received conventional training with the same contact time.
                Patients were assessed on days 0, 30 and 60 using the Behavioural Inattention Test, the Clock Drawing Test, and the Functional Independence Measure.
                No significant differences between voluntary trunk rotation (TR), voluntary trunk rotation and half-field eye-patching (TR + EP) and controls were found in functional performance and neglect measures at day 30 (P = 0.042-0.994) and follow-up (P = 0.052-0.911) at P = 0.005 using Bonferroni correction.
                The results of this study do not support the use of voluntary trunk rotation alone or with half-field eye-patching to improve functional performance or reduce unilateral neglect in subacute patients with stroke. Three surgeons operated on upper eye lids of northern Omani villagers for trichiasis due to trachoma using a standardised protocol. The lids were graded as minor trichiasis, five or fewer lashes; major trichiasis, six or more lashes; and lid closure defect. Operative success was defined as no lash/eyeball contact and complete gentle lid closure. One hundred and sixty five lids with major trichiasis were allocated by random number tables to one of five operations: bilamellar tarsal rotation (Ballen), tarsal advance and rotation (modified Trabut), eversion splinting (grey line), tarsal advance (lid split), and tarsal grooving (Streatfield-Snellen) operations. Bilamellar tarsal rotation was significantly more successful than eversion splinting (chi 2 = 7.0, p less than 0.01); tarsal advance (chi 2 = 12.4, p less than 0.001), and tarsal grooving (chi 2 = 23.7, p less than 0.001), but not significantly more successful than tarsal advance and rotation (chi 2 = 2.9, p greater than 0.05). Two of 32 (6%) lids with lid closure defect were successfully treated with tarsal advance; trichiasis was relieved in nine and lid closure defect in 10. It is suggested that bilamellar tarsal rotation and tarsal advance and rotation are effective operations for major trichiasis, but tarsal advance is ineffective where trichiasis and lid closure defect coexist.
A single RCT showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for entropion compared to vertical tightening with everting sutures alone. Retrospective case series studies also support the combined surgical repair but details from these studies on specific surgical techniques cannot be included in the analysis.
Evidence from a single RCT is unlikely to change clinical practice and thus it is still our view that there is a clear need for more randomised studies comparing two or more surgical techniques for entropion surgery addressing the recurrence and complications rate.