Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial.
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ABSTRACT:
SUBMITTER: Feigenberg T
PROVIDER: S-EPMC4095740 | biostudies-literature | 2014
REPOSITORIES: biostudies-literature
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Project description:IntroductionPerineal lacerations during childbirth are common, and suturing the perineal skin during repair has been associated with increased postpartum pain. This study sought to test the hypothesis that no difference in postpartum perineal pain exists between 3 methods of skin closure for second-degree repair: suture, no suture, and surgical glue.MethodsA single-blind randomized controlled trial of women after vaginal birth who had a second-degree perineal laceration was conducted at a tertiary care teaching hospital from August 2014 to April 2017. Women were randomized to perineal skin closure with suture, no suture, or surgical glue using a 1:1:1 allocation. Pain was assessed using the short-form McGill Pain Questionnaire, a 100-mm visual analog scale (VAS), and Present Pain Index (PPI) at one day, 2 weeks, 6 weeks, and 3 months postpartum. Wound healing was assessed at 6 weeks using the Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA) scale. Pain scores were compared across groups using a chi-square test, Mann-Whitney U test, or analysis of variance where appropriate.ResultsA total of 35 women were randomized: 14 received suture, 11 had no suture, and 10 received surgical glue for perineal skin repair. Demographic characteristics were similar between groups. At 2 weeks postpartum, women with suture had higher median pain scores on the short-form McGill Pain Questionnaire (15.0 suture vs 2.0 glue vs 2.0 no suture, P = .03) and VAS (50.0 suture vs 3.0 glue vs 7.0 no suture, P = .02). Significant differences in pain were not seen on the PPI. At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04). Wound healing was similar across groups (REEDA score: 0 suture vs 1.0 no suture, vs 0 surgical glue, P = .24).DiscussionCompared with no suture and surgical glue, suturing the perineal skin was associated with the highest postpartum pain scores.
| S-EPMC7747225 | biostudies-literature
Project description:Long term effects of perineal tears pose a major worldwide health issue for women during delivery. Since bacterial vaginosis is related to major obstacles in obstetrics the aim of this study was to determine the relationship between bacterial vaginosis and the occurrence of perineal tears during vaginal delivery.Between June 2013 and December 2013 pregnant women delivering after 37 weeks were recruited at one University hospital / tertiary care referral center in the course of this single-center, prospective cohort study. Bacterial vaginosis was assessed according to Nugent score method. Logistic-regression model was used to estimate odds ratios, adjusted for other risk factors to test the relationship between bacterial vaginosis and the occurrence of 1st to 4th degree perineal tears in women undergoing vaginal delivery.A total of 728 woman were included, 662 analyzed with a complete Nugent Score of the vaginal swab. The prevalence of 1st to 4th degree perineal tears was 35.8% (95% Confidence Interval (95%CI) = [32.2; 39.6]). The presence of BV was not significantly associated to the incidence of perineal tears neither in the univariate analysis (crude Odds Ratio = 1.43; 95%CI = [0.79; 2.60]; p = 0.235) nor in the multivariate analysis (adjusted Odds Ratio = 1.65; 95%CI = [0.81; 3.36]; p = 0.167). Instrumental delivery was the most important risk factor for perineal lacerations.There is no evidence that vaginosis is a risk factor for vaginal tears.ClinicalTrials.gov N° NCT01822782.
| S-EPMC4636351 | biostudies-literature
Project description:Background: The aim of this study was to estimate the incidence of second-degree perineal tears, obstetric anal sphincter injuries (OASI), and high vaginal tears in primiparous women, and to examine how sociodemographic and pregnancy characteristics, hereditary factors, obstetric management and the delivery process are associated with the incidence of these tears.Methods: All nulliparous women registering at the maternity health care in Region Örebro County, Sweden, in early pregnancy between 1 October 2014 and 1 October 2017 were invited to participate in a prospective cohort study. Data on maternal and obstetric characteristics were extracted from questionnaires completed in early and late pregnancy, from a study-specific delivery protocol, and from the obstetric record system. These data were analyzed using unadjusted and adjusted multinomial and logistic regression models.Results: A total of 644 women were included in the study sample. Fetal weight exceeding 4000?g and vacuum extraction were found to be independent risk factors for both second-degree perineal tears (aOR 2.22 (95% CI: 1.17, 4.22) and 2.41 (95% CI: 1.24, 4.68) respectively) and OASI (aOR 6.02 (95% CI: 2.32, 15.6) and 3.91 (95% CI: 1.32, 11.6) respectively). Post-term delivery significantly increased the risk for second-degree perineal tear (aOR 2.44 (95% CI: 1.03, 5.77), whereas, maternal birth positions with reduced sacrum flexibility significantly decreased the risk of second-degree perineal tear (aOR 0.53 (95% CI 0.32, 0.90)). Heredity of pelvic floor dysfunction and/or connective tissue deficiency, induced labor, vacuum extraction and fetal head circumference exceeding 35?cm were independent risk factors for high vaginal tears (aOR 2.32 (95% CI 1.09, 4.97), 3.16 (95% CI 1.31, 7.62), 2.53 (95% CI: 1.07, 5.98) and 3.07 (95% CI 1.5, 6.3) respectively).Conclusion: The present study corroborates previous findings of vacuum extraction and fetal weight exceeding 4000?g as risk factors of OASI. We found that vacuum extraction is a risk factor for second-degree tear, and vacuum extraction, fetal head circumference exceeding 35?cm and heredity of pelvic floor dysfunction and/or connective tissue deficiency were associated with increased risk of high vaginal tears. These findings have not been documented previously and should be confirmed by additional studies.
| S-EPMC7709229 | biostudies-literature
Project description:OBJECTIVE:Sexuality is an important aspect of human identity and contributes significantly to the quality of life in women as well as in men. Impairment in sexual health after vaginal delivery is a major concern for many women. We aimed to examine the association between degree of perineal tear and sexual function 12 months postpartum. DESIGN:A prospective cohort study SETTING: Four Danish hospitals between July 2015 and January 2019 PARTICIPANTS: A total of 554 primiparous women: 191 with no/labia/first-degree tears, 189 with second-degree tears and 174 with third-degree/fourth-degree tears. Baseline data were obtained 2 weeks postpartum by a questionnaire and a clinical examination. Sexual function was evaluated 12 months postpartum by an electronic questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)) and a clinical examination. PRIMARY OUTCOME MEASURES:Total PISQ-12 score and dyspareunia RESULTS: Episiotomy was performed in 54 cases and 95 women had an operative vaginal delivery. The proportion of women with dyspareunia was 25%, 38% and 53% of women with no/labia/first-degree, second-degree or third-degree/fourth-degree tears, respectively.Compared with women with no/labia/first-degree tears, women with second-degree or third-degree/fourth-degree tears had a higher risk of dyspareunia (adjusted relative risk (aRR) 2.05; 95%?CI 1.51 to 2.78 and aRR 2.09; 95%?CI 1.55 to 2.81, respectively). Women with third-degree/fourth-degree tears had a higher mean PISQ-12 score (12.2) than women with no/labia/first-degree tears (10.4). CONCLUSIONS:Impairment of sexual health is common among primiparous women after vaginal delivery. At 12 months postpartum, more than half of the women with a third-degree/fourth-degree tear experienced dyspareunia. Women delivering with no/labia/first-degree tears reported the best outcomes overall. Thus, it is important to minimise the extent of perineal trauma and to counsel about sexuality during and after pregnancy.
| S-EPMC6937116 | biostudies-literature
Project description:OBJECTIVE: We aimed at investigating prospective memory and its socio-demographic and neurocognitive correlates in non-psychotic, first-degree relatives (FDRs) of patients with schizophrenia compared to patients with first episode schizophrenia (FES), and healthy controls (HCs). METHODS: Forty-seven FES patients, 50 non-psychotic FDRs (23 offspring and 27 siblings) of patients with chronic schizophrenia (unrelated to the FES group) and 51 HCs were studied. The Chinese version of the Cambridge Prospective Memory Test (C-CAMPROMPT) was used to measure time-based prospective memory (TBPM) and event-based prospective memory (EBPM) performance. Other cognitive functions (involving respective memory and executive functions) were evaluated with standardized tests. RESULTS: After controlling for basic demographic characteristics including age, gender and educational level, there was a significant difference between FDRs, FES and HCs with respect to both TBPM (F(2,142) = 10.4, p<0.001) and EBPM (F(2,142) = 10.8, p<0.001). Multiple linear regression analyses revealed that lower scores of the Hopkins Verbal Learning Test-Revised (HVLT-R) and the STROOP Word-Color Test (SWCT) contributed to TBPM impairment, while lower educational level and higher scores of the Color Trails Test-2 (CTT-2) contributed to EBPM deficit in FDRs. CONCLUSIONS: FDRs share similar but attenuated prospective memory impairments with schizophrenia patients, suggesting that prospective memory deficits may represent an endophenotype of schizophrenia.
| S-EPMC4218767 | biostudies-other
Project description:BackgroundDespite advances in surgical techniques, the use of maximal repair to treat large or massive rotator cuff tears results in a high retear rate postoperatively. Currently, no randomized controlled trials have compared the outcomes of maximal repair with interposition dermal allograft bridging reconstruction.HypothesisWe hypothesized that large or massive rotator cuff tendon tears reconstructed using bridging dermal allograft would have better clinical outcomes 2 years postoperatively, as measured using the Western Ontario Rotator Cuff (WORC) index, than would those receiving the current gold standard treatment of debridement and maximal repair alone. We also expected that patients treated via bridging reconstruction using dermal allograft would have fewer postoperative failures as assessed using postoperative magnetic resonance imaging scans.Study designRandomized controlled trial; Level of evidence 1.MethodsA sample size of 30 patients (determined using a priori sample size calculation) with massive, retracted rotator cuff tears were randomly allocated to 1 of 2 groups: maximal repair or bridging reconstruction using dermal allograft. All patients completed questionnaires (WORC and Disabilities of the Arm, Shoulder and Hand [DASH]) preoperatively and postoperatively at 3 months, 6 months, 1 year, and 2 years. The primary outcome of this study was the WORC index at 2 years. Secondary outcomes included healing rate, progression of rotator cuff arthropathy, and postoperative acromiohumeral distance in both groups.ResultsPatients treated via bridging reconstruction using dermal allograft had better postoperative WORC and DASH scores (23.93 ± 24.55 and 15.77 ± 19.27, respectively) compared with patients who received maximal repair alone (53.36 ± 31.93 and 34.32 ± 23.31, respectively). We also noted increased progression to rotator cuff arthropathy in the maximal repair group with an increased retear rate when compared with the reconstruction group (87% and 21%, respectively; P < .001). The acromiohumeral distance was maintained in the reconstruction group but significantly decreased in the maximal repair group.ConclusionRotator cuff bridging reconstruction using a dermal allograft demonstrated improved patient-reported outcomes as measured using the WORC index 2 years postoperatively. This technique also showed favorable structural healing rates and decreased progression to arthropathy compared with maximal repair.Trial registrationClinicalTrials.gov (NCT01987973).
| S-EPMC8485417 | biostudies-literature
Project description:ObjectiveTo compare the effects of arthroscopic debridement and repair in treating Ellman grade II bursal-side partial-thickness rotator cuff tears.MethodsThis is a single-center, prospective, randomized controlled trial. From September 2017 to April 2019, 78 patients underwent arthroscopic debridement (35 patients) or repair (43 patients) due to Ellman grade II bursal-side partial-thickness rotator cuff tears. Twenty-six men and 52 women were included in the study, with an average age of 56.31 years (range, 42 to 74 years). After the acromioplasty was formed, the debridement group only performed stump refreshing and surrounding soft tissue cleaning, while the repair group converted the partial tears into full-thickness tears and then sutured them by single row or suture bridge technique. The visual analogue scale (VAS), Constant-Murley shoulder (CMS), American Shoulder and Elbow Surgeons (ASES), and University of California, Los Angeles (UCLA) scores were used to evaluate clinical results preoperatively and at 6, 12, and 18 months postoperatively. Magnetic resonance imaging was used to assess the integrity of the rotator cuff, muscle atrophy, and fat infiltration.ResultsA total of 85 patients met the inclusion criteria and were randomly divided into the debridement group (41 patients) and the repair group (43 patients). During the 18-month follow-up period, a total of seven patients were lost to follow-up. The functional scores of both groups were significantly improved: the VAS score decreased 5.06 and 4.63 in the debridement group (5.77 preoperative to 0.71 postoperative) and the repair group (5.49 to 0.86) (P < 0.05). Moreover, the CMS, ASES, UCLA scores increased 51.63, 58.24, 20.57 in debridement group (39.46 to 91.09, 34.14 to 92.38, 13.29 to 33.86), and increased 48.14, 60.53, 20.93 in repair group (43.63 to 91.77, 33.10 to 93.63, 12.58 to 33.51) (P < 0.05). No significant differences were found in functional scores between the two groups at 6, 12, and 18 months postoperatively (P > 0.05). The magnetic resonance imaging showed no re-tears, and no difference was observed in the degree of muscle atrophy and fat infiltration between the two groups (P > 0.05). Except for four cases of shoulder stiffness, no other obvious surgery-related complications were found.ConclusionFor Ellman grade II bursal-side partial-thickness rotator cuff tears, both the debridement and repair groups achieved good results during 18-month follow-ups, with no difference between the two groups.
| S-EPMC8528987 | biostudies-literature
Project description:BackgroundThe efficacy of perineal self-acupressure in treating constipation is uncertain.ObjectiveWe aimed to evaluate whether perineal self-acupressure would improve patient reports of quality of life and bowel function at 4 weeks after training.DesignA randomized, parallel group trial was conducted.SettingThe study took place at the UCLA Department of Medicine.PatientsOne hundred adult patients who met Rome III criteria for functional constipation participated.InterventionThe control group received information about standard constipation treatment options, while the treatment group received training in perineal self-acupressure plus standard treatment options.MeasurementsPrimary outcome was the Patient Assessment of Constipation Quality of Life (PAC-QOL). Secondary outcomes included patient assessments of bowel function (as measured by a modified Bowel Function Index (BFI)), and health and well-being (as measured by the SF-12v2).ResultsThe mean PAC-QOL was improved by 0.76 in the treatment group and by 0.17 in the control group (treatment-effect difference, 0.59 [95 % CI, 0.37 to 0.81]; p < 0.01). The mean modified BFI was improved by 18.1 in the treatment group and by 4.2 in the control group (treatment-effect difference, 13.8 [95 % CI, 5.1 to 22.5]; p < 0.01). The mean SF-12v2 Physical Component Score was improved by 2.69 in the treatment group and reduced by 0.36 in the control group (treatment-effect difference, 3.05, [95 % CI, 0.85 to 5.25]; p < 0.01); and the mean SF-12v2 Mental Component Score was improved by 3.12 in the treatment group and improved by 0.30 in the control group (treatment-effect difference, 2.82, [95 % CI, -0.10 to 5.74]; p < 0.07).LimitationThe trial was not blinded.ConclusionAmong patients with constipation, perineal self-acupressure improves self-reported assessments of quality of life, bowel function, and health and well-being relative to providing standard constipation treatment options alone.
| S-EPMC4371012 | biostudies-literature
Project description:Background:The study focusing on the tissue adhesive in total knee arthroplasty (TKA) was rare. This study aimed to evaluate the clinical outcomes and economic costs of tissue adhesive when acting as the adjunct to standard incision closure in TKA. Patients and Methods:From September 2019 to November 2019, we prospectively enrolled the consecutive patients who underwent simultaneous bilateral TKA in our institute. The allocation using the tissue adhesive was done after the subcuticular suture in right knee first and another method was applied in the left knee automatically. The patients' demographics, length of stay (LOS), times of dressing changes and incision-related cost, range of motion (ROM), incision-related complications and incision evaluation scores were recorded. Results:Thirty-two patients were enrolled in this study and followed at two months after surgery. In the knees of tissue adhesive, the times of dressing change and patient scar assessment scores (PSAS) were significantly less than those standard skin closure (p=0.000; p=0.003). Although there were no significant differences of the delayed discharge, incision-related cost, ROM, incision-related complications and Vancouver scar score (VSS) between two groups, 65.6% (21/32) patients preferred the tissue adhesive and only 15.6% (5/32) patients preferred the standard incision closure. Conclusion:Tissue adhesive could effectively reduce postoperative wound drainage and improve patients' satisfaction rate with no difference in medical costs and ROM in TKA. The application of tissue adhesive and subcuticular sutures might be one safe and convenient method of skin closure in TKA. Chinese Clinical Trial Registry:ChiCTR1900025730; Registered 6 September 2019.
| S-EPMC7457845 | biostudies-literature
Project description:BackgroundAdhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of re-admission after intra-abdominal surgery. The initial management of patients with ASBO is nonoperative treatment such as nil per os and decompression using a nasogastric tube. However, the ideal management of ASBO remains controversial.MethodsThis study will be a prospective, single-center, double-blind randomized controlled trial. Ninety two participants diagnosed with ASBO will be randomly assigned to either the verum or the sham laser acupuncture (SLA) group in a 1:1 ratio. All participants will undergo laser acupuncture (LA) or SLA once a day on 6 acupoints (LI4, PC6, ST25, ST36, CV4 and CV12) for 6 consecutive days after enrollment. The primary outcome measure will be the success rate of conservative treatment for ASBO. Secondary outcomes will be time to oral intake and length of hospital stay. The serum levels of lipase, amylase, cortisol, motilin, ghrelin, and intestinal fatty acid binding protein (I-FABP) will also be measured before intervention, on day 4, and on the day of discharge, respectively. Data will be analyzed by Chi-Squared test or t test between 2 groups.ObjectivesThe aim of this protocol is to investigate the clinical efficacy of LA on ASBO.Trial registrationClinicalTrials.gov Identifier: NCT04318821. Registered on 24 March 2020.
| S-EPMC7939224 | biostudies-literature