Dataset Information

Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial.

ABSTRACT: Our objective was to evaluate the effectiveness of adhesive glue in repairing first degree perineal tears. We conducted a noninferiority prospective, randomized, controlled trial comparing adhesive glue with traditional suturing. Each case was evaluated immediately after birth and after the puerperium. The two-sample t-test and the Mann-Whitney nonparametric test were applied to compare quantitative variables between the treatment groups. The chi-squared test and Fisher's exact test were used to assess the association between qualitative variables. A total of 102 women participated, 28 in the suture arm and 74 in the adhesive glue arm. While cosmetic and functional results of adhesive glue use were not inferior to suturing, the use of adhesive glue was associated with a shorter procedure, less need for local anesthetic, less pain, and greater satisfaction. Our results suggest a novel approach for the repair of common postpartum first degree lacerations. The use of adhesive glue achieves cosmetic and functional results equal to traditional suturing and offers some immediate advantages for the patient. While further clinical trials are needed to validate our results, it is important to inform obstetrician of the possible use of adhesive glue in these very common clinical scenarios. This trial is registered with NCT00746707.

SUBMITTER: Feigenberg T

PROVIDER: S-EPMC4095740 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial.

Feigenberg Tomer T Maor-Sagie Esther E Zivi Einat E Abu-Dia Mushira M Ben-Meir Assaf A Sela Hen Y HY Ezra Yossef Y

BioMed research international 20140626

Our objective was to evaluate the effectiveness of adhesive glue in repairing first degree perineal tears. We conducted a noninferiority prospective, randomized, controlled trial comparing adhesive glue with traditional suturing. Each case was evaluated immediately after birth and after the puerperium. The two-sample t-test and the Mann-Whitney nonparametric test were applied to compare quantitative variables between the treatment groups. The chi-squared test and Fisher's exact test were used to ...[more]

PMID: 25089271

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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.

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.

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.

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).

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.

Dataset Information

Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial.

Publications

Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial.

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