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Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.

ABSTRACT: INTRODUCTION:The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy, which is known to have a high recurrence rate. Several factors might affect the outcome of anterior colporrhaphy, and the use of absorbable sutures might also be associated with the high recurrence rate because the sutures might not be able to retain adequate strength until the plicated pubocervical fascia remodels and regains maximum tensile strength. Nonetheless, no comparative data exist about the relative efficacy and safety of anterior colporrhaphy using non-absorbable versus absorbable sutures. The objective of this study is to compare the surgical outcomes of anterior colporrhaphy using non-absorbable sutures with those of anterior colporrhaphy using absorbable sutures. METHODS AND ANALYSIS:This is a randomised, multicentre, superiority trial. Anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either non-absorbable or absorbable sutures. The primary outcome is composite surgical success 1?year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary. The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. The planned number of participants is 192. ETHICS AND DISSEMINATION:This study was approved by the Institutional Review Board of Seoul National University Hospital (H-1810-037-977). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings. TRIAL REGISTRATION NUMBER:NCT03736811.

SUBMITTER: Jeon MJ

PROVIDER: S-EPMC7304798 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.

Jeon Myung Jae MJ Suh Dong Hoon DH Kim Chul Hong CH Cho Hyun-Hee HH Shin Jung-Ho JH Lee Sa Ra SR Jung Yong Wook YW Kim Soo Rim SR Kong Mi Kyung MK

BMJ open 20200616 6

<h4>Introduction</h4>The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy, which is known to have a high recurrence rate. Several factors might affect the outcome of anterior colporrhaphy, and the use of absorbable sutures might also be associated with the high recurrence rate because the sutures might not be able to retain adequate strength until the plicated pubocervical fascia remodels ...[more]

PMID: 32554735

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Project description:Simple Summary The choice of suture material for skin closure can affect the final cosmetic outcome, the risk of wound infection and other complications in companion animals. We assessed two commercially available suture materials, namely, Monocryl and Securex, for use in suturing the skin of dogs, using cosmetic, clinical, ultrasonographic and histological evaluations. The results indicated only minimal differences between the two products, although better scores were achieved using Monocryl. Both were found to be sufficient for use in intradermal suturing in dogs. The earlier removal of Securex compared to Monocryl did not have any additional beneficial effect on wound healing and scar appearance in dogs. Abstract The study aimed to compare incisional wound healing with intradermal suture patterns performed with (a) absorbable suture with burying of the knots and (b) nonabsorbable suture anchored with clips. Ten dogs were included in the study. Surgically created skin incisions were apposed with continuous intradermal suture pattern with 4/0 poliglecaprone 25 with burying of the knots and continuous intradermal pattern with 4/0 polypropylene with clips. Cosmetic, clinical, ultrasonographic and histological scores were evaluated. The intradermal pattern with clips was easier to perform and required significantly less time to complete than the intradermal suture with burying of the knots. Cosmetic, clinical, ultrasonographic and histological evaluation scores did not differ significantly between the techniques. Irrespective of the technique used, the cosmetic, ultrasonographic, clinical and histological appearances of the incisions improved over time. In conclusion, polypropylene was found to be a safe and effective suture material for use with intradermal suture pattern with clips in dogs and to have an easy and quick application. However, in our sample, its earlier removal from wounds than poliglecaprone 25 was not found to be associated with a supposedly beneficial effect on wound healing and scar appearance. Both suture materials can be useful in intradermal suture techniques in dogs.

Project description:IntroductionAnastomotic leakage is the most important complication in colorectal surgery occurring in up to 20% after low anterior rectal resection. Therefore, a diverting ileostomy is usually created during low anterior resection to protect the anastomosis or rather to diminish the consequences in case of anastomotic leakage. The so-called virtual or ghost ileostomy is a pre-stage ostomy that can be easily exteriorised, if anastomotic leakage is suspected, in order to avoid the severe consequences of anastomotic leakage. On the other hand, an actual ileostomy can be avoided in patients, who do not develop anastomotic leakage.Methods and analysisThe GHOST trial is a randomised controlled pilot trial comparing ghost ileostomy with conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision for rectal cancer. After screening for eligibility and obtaining informed consent, a total of 60 adult patients are included in the trial. Patients are intraoperatively randomised to the trial groups in a 1:1 ratio after assuring that none of the intraoperative exclusion criteria are present. The main outcome parameter is the comprehensive complication index as a measure of safety. Further outcomes include specific complications, stoma-related complications, complications of ileostomy closure, frequency of transformation of ghost ileostomy into conventional ileostomy, frequency of terminal ostomy creation, proportion of patients with an ostomy at 6 months after index surgery, anorectal function (Wexner score) and quality of life assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Follow-up for each individual patient will be 6 months.Ethics and disseminationThe GHOST trial has been approved by the Medical Ethics Committee of Heidelberg University (reference number S-694/2017). If the intervention proves to be safe, loop ileostomy could be spared in a large proportion of patients, thus also avoiding stoma-related complications and a second operation (ileostomy closure) with its inherent complications in these patients.Trial registration numberGerman Clinical Trials Registry (DRKS00013997); Universal Trial Number: U1111-1208-9742.

Project description:BackgroundLateral humeral condyle fractures are the second most common elbow fracture in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used in the fixation of these fractures. Here, we introduce a new fixation method that uses an absorbable screw. We aim to determine if it is feasible to treat lateral humeral condyle fractures with an absorbable screw by comparing functional outcomes following absorbable screw fixation vs. K-wire fixation.MethodsBetween May 2007 and September 2010, 86 patients were treated with absorbable screws (43 patients) or K-wire (43 patients). All patients had been diagnosed with lateral condyle fractures that were classified as either Jacob type II (unstable) or III. One absorbable screw (3.5 mm-diameter) was used for fixation in 1 group, while two 1.6 to 1.8 mm K-wires were used in the other group. Patients were followed 6 months about the elbow function according to Broberg and Morrey standard. On 5-7 years, the patients were followed about the carrying angle (valgus deformities and varus deformities), range of motion (flexion loss and extension loss), prominent lateral condyle, symptomatic implants, and fishtail deformity.ResultsAnatomic reduction was achieved in all patients. Each group had one radial nerve injury that were present preoperatively. Nerve function recovered spontaneously within 3 to 4 weeks of surgery in both patients. No patient developed necrosis of the capitulum in both groups. Nine patients in K-wires group and 2 in absorbable screw group developed symptomatic implants (P = .048). On the sixth month, there was no significant difference on elbow function according to Broberg and Morrey standard. On 5 to 7 years (average, 6.7 ± 1.3 years), valgus deformities was 6.8 ± 1.2 vs 5.7 ± 0.8, varus deformities was 7.2 ± 1.5 vs 5.1 ± 1.9, flexion loss was 12.4 ± 2.2 vs 9.5 ± 3.1, extension loss was 11.1 ± 3.1 vs 10.2 ± 2.7, prominent lateral condyle was 27.9% vs 37.2%, fishtail deformity was 7.3% vs 4.9%, no significant difference between these groups.ConclusionsOpen reduction with absorbable screw fixation is feasible and safe for the treatment of lateral condyle fractures of the humerus in children.Level of evidenceTherapeutic III.

Project description:BACKGROUND:Laparoscopic repair of ventral and incisional hernias has gained popularity since many studies have reported encouraging results in terms of outcomee and recurrence. Choice of mesh and fixation methods are considered crucial issues in preventing recurrences and complications. Lightweight meshes are considered the first choice due to their biomechanical properties and the ability to integrate into the abdominal wall. Titanium helicoidal tacks still represent the "gold standard" for mesh fixation, even if they have been suggested to be involved in the genesis of post-operative pain and complications. Recently, absorbable tacks have been introduced, under the hypothesis that there will be no need to maintain a permanent fixation device after mesh integration. Nevertheless, there is no evidence that absorbable tacks may guarantee the same results as titanium tacks in terms of strength of fixation and recurrence rates. The primary end point of the present trial is to test the hypothesis that absorbable tacks are non-inferior to titanium tacks in laparoscopic incisional and ventral hernia repair (LIVHR) by lightweight polypropylene mesh, in terms of recurrence rates at 3-year follow-up. Surgical complications, post-operative stay, comfort and pain are secondary end points to be assessed. METHODS/DESIGN:Two hundred and twenty patients with ventral hernia will be randomized into 2 groups: Group A (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by titanium tacks; Group B (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by absorbable tacks. DISCUSSION:A few retrospective studies have reported similar results when comparing absorbable versus non-absorbable tacks in terms of intraoperative and early post-operative outcomes. These studies have the pitfalls to be retrospective evaluation of small series of patients, and the reported results still need to be validated by larger series and prospective studies. The aim of the present trial is to investigate and test the non-inferiority of absorbable versus non-absorbable tacks in terms of hernia recurrence rates, in order to assess whether the use of absorbable tacks may achieve the same results as non-absorbable tacks in mid-term and long-term settings. TRIAL REGISTRATION NUMBER:NCT02076984: 5 June 2014 (ClinicalTrials.gov).

Project description:IntroductionPulmonary rehabilitation (PR), an exercise and education programme for people with chronic lung disease, aims to improve exercise capacity, breathlessness and quality of life. Most evidence to support PR is from trials that use specialist exercise equipment, for example, treadmills (PR-gym). However, a significant proportion of programmes do not have access to specialist equipment with training completed with minimal exercise equipment (PR-min). There is a paucity of robust literature examining the efficacy of supervised, centre-based PR-min. We aim to determine whether an 8-week supervised, centre-based PR-min programme is non-inferior to a standard 8-week supervised, centre-based PR-gym programme in terms of exercise capacity and health outcomes for patients with chronic lung disease.Methods and analysisParallel, two-group, assessor-blinded and statistician-blinded, non-inferiority randomised trial. 436 participants will be randomised using minimisation at the individual level with a 1:1 allocation to PR-min (intervention) or PR-gym (control). Assessment will take place pre-PR (visit 1), post-PR (visit 2) and 12 months following visit 1 (visit 3). Exercise capacity (incremental shuttle walk test), dyspnoea (Chronic Respiratory Questionnaire (CRQ)-Dyspnoea), health-related quality of life (CRQ), frailty (Short Physical Performance Battery), muscle strength (isometric quadriceps maximum voluntary contraction), patient satisfaction (Global Rating of Change Questionnaire), health economic as well as safety and trial process data will be measured. The primary outcome is change in exercise capacity between visit 1 and visit 2. Two sample t-tests on an intention to treat basis will be used to estimate the difference in mean primary and secondary outcomes between patients randomised to PR-gym and PR-min.Ethics and disseminationLondon-Camden and Kings Cross Research Ethics Committee and Health Research Authority have approved the study (18/LO/0315). Results will be submitted for publication in peer-reviewed journals, presented at international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders.Trial registration numberISRCTN16196765.

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Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.

Publications

Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.

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