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Two commonly performed surgical interventions are available for severe (grade II–IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II–IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference −0·073 (95% CI −0·140 to −0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled haemorrhoidopexy group. 24 (7%) of 338 participants who received stapled haemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. As part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice. National Institute for Health Research Health Technology Assessment programme.

Objective Timely and complete surgical wound healing substantially affects the patient’s performance and satisfaction with surgery outcomes. Sutures and staples are two common wound closure methods in total knee arthroplasty; however, their role in reducing the rate of surgical wound infections and dehiscence in diabetic patients is unclear. Therefore, this study was conducted to investigate the rate of infection and post-closure dehiscence in wounds closed with either nylon sutures or skin staples in diabetic patients undergoing total knee arthroplasty (TKA). Methods This is a single-blind randomized clinical trial including 70 diabetic mellitus patients undergoing TKA. Patients were selected using a restricted random sampling method and haphazardly assigned to study groups using the permuted block randomization technique, including the suture-closed ( n  = 35) and staple-closed ( n  = 35) groups. The follow-up was 2 to 8 weeks after the surgery, evaluation of wound infection and dehiscence was performed. Results The present study showed that there was no significant correlation between wound infection rate (P-value = 0.254) and wound dehiscence (P-value = 0.324) with the method of wound closure (i.e., sutures or staples). However, surgical wound dehiscence revealed a significant correlation with body mass index (BMI) (P-value = 0.044), Glycosylated hemoglobin (HbA1c) (P-Value = 0.001), and fasting blood glucose (FBS) (P-Value = 0.012) in diabetic mellitus patients. Conclusion The use of the staple technique compared to suture had no difference in the rate of wound opening and infection, but from a clinical point of view, the prevalence of wound opening after TKA in patients with the suture method was higher than that of staples. Further research is needed to confirm these findings and the long-term efficacy of each method. Clinical trial registration The present study was registered at the Iranian Registry of Clinical Trails (No. IRCT20230928059543N1, Trial Id:74754, approved on 12/01/2024, https://irct.behdasht.gov.ir/user/trial/74754/view ) and conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Background Parastomal herniation is a prevalent complication of colostomies, with rates as high as 60% at 2 years. Traditional methods, including mesh use, have shown limited success. Here, we aim to compare 1-year PSH rates and evaluate stoma-related complications using a stapled versus conventional approach. Methods This randomized controlled trial investigates the efficacy of using a circular stapler to create an end colostomy for reducing parastomal hernia (PSH) incidence compared to conventional techniques. Eligible patients (aged 18–70) undergoing end colostomy for rectal cancer at Tata Memorial Hospital will be randomized into two groups: circular stapled versus conventional cruciate incision. Primary outcomes will be 1-year PSH rates, determined clinically and radiologically, with secondary outcomes including short-term stoma-related complications and reoperation rates. Discussion The study’s findings will provide evidence on the circular stapler’s effectiveness in reducing PSH incidence, potentially offering an innovative approach to ostomy creation. If successful, this technique may improve patient outcomes and reduce long-term healthcare costs related to PSH management. Trial registration CTRI/2023/10/059362; protocol version 1.2. Registered on March 11, 2023

Introduction Repair of inguinal hernia is one of the most common elective operations performed in general surgery practice. Mesh hernia repair became the gold standard because of its low recurrence rate in comparison with non-tension-free repair. Laparoscopic approach seems to have potential advantages over open techniques, including faster recovery and reduced acute and chronic pain rate. Laparoscopic mesh fixation is usually performed using staples, which is associated with higher cost and risk for chronic pain. Recently, the role of mesh fixation has been questioned by several surgeons. Aim To evaluate mesh displacement in patients undergoing laparoscopic inguinal hernia repair comparing mesh fixation with no fixation. Methods From January 2012 to May 2014, 60 consecutive patients with unilateral inguinal hernia were randomized into two groups: control group—10 patients underwent totally extraperitoneal (TEP) repair with mesh fixation; NO FIX group—50 patients underwent TEP repair with no mesh fixation. Mesh was marked with three 3-mm surgical clips at its medial inferior, medial superior and lateral inferior corners. Mesh displacement was measured by comparing an initial X-ray, performed in the immediate postoperative period, with a second X-ray obtained 30 days later. Results The mean displacement of all three clips in control group was 0.1–0.35 cm (range 0–1.2 cm), while in NO FIX group was 0.1–0.3 cm (range 0–1.3 cm). The overall displacement of control and NO FIX group did not show any difference ( p  = 0.50). Conclusion Fixation of the mesh for TEP repair is unnecessary. TEP repair with no mesh fixation is safe and is not associated with increased risk of mesh displacement.

BackgroundVarieties of intraoperative methods such as oversewing of staple lines or other reinforcement products are used for preventing the laparoscopic vertical sleeve gastrectomy (LSG) complications. The aim of this study is to evaluate the complication rates of the gastric stapling alone versus stapling with oversewing invagination of the staple line in the LSG.MethodsThis is a single-center randomized study, Patients were randomized to two groups, 200 patients underwent LSG without reinforcement of the staple line and 200 patients underwent LSG with oversewing of the staple line. All patients were followed up for 1 year. The data collected prospectively for statistical analysis included demographics, BMI, preoperative comorbidities, operative time, complications, and hospital stay.ResultsThe overall mean operative age was 33.7 ± 9.4 years and mean BMI was 42.4 ± 4.3 kg/m2. Patient baseline characteristics (age, gender, weight, and BMI) and comorbidities were generally a nonsignificant different between the treatment arms. Surgical time was shorter in patients of the nonreinforced group (44.3 ± vs 51.3 ± 4.3 min; p < 0.01) with lower %EWL (73 ± 13.8 vs 80.7 ± 13.6%, p < 0.01). One patient in the nonreinforced group was complicated by gastric leak. The staple-line bleeding rate was significantly lower in patients underwent oversewing of the staple line during LSG (p < 0.05).ConclusionOversewing of the staple line during LSG is a nonexpansive and easy method to decrease the incidence and severity of the postoperative bleeding. However, it is time-consuming and should be performed by experienced surgeons to avoid the complications which may occur secondary to the seroserotomy suturing.

Background Maintaining robust perfusion is an important physiologic parameter in wound healing. The effect of different closure techniques on wound perfusion after total knee arthroplasty (TKA) has not been established previously and may have implications for wound healing. Questions/purposes We asked whether a running subcuticular, vertical mattress, or skin staple closure technique enables the most robust wound perfusion after TKA as measured by laser-assisted indocyanine green angiography (LA-ICGA) in patients without specific risk factors for wound healing complications. Methods Forty-five patients undergoing primary TKA without comorbidities known to impact wound healing and perfusion were prospectively randomized to receive superficial skin closure with one of the following techniques: (1) running subcuticular (3-0 monofilament); (2) vertical mattress (2-0 nylon); or (3) skin staples. Twenty procedures were performed by RTT, 15 by RJS, and 10 by FHS. All surgeons used an anterior skin incision over the medial third of the patella in combination with a median parapatellar arthrotomy. Perfusion was assessed with a LA-ICGA device and software system immediately after closure to quantify fluorescence. Twenty-seven points were assessed immediately after closure in the operating room in each patient (nine along the incision and nine pairs medial and lateral to the incision). Mean incision perfusion was determined from the nine points along the incision with higher values indicating greater blood flow. Mean perfusion impairment was determined by calculating the difference between the nine pairs of surrounding skin and the nine points along the incision with smaller values indicating less perfusion impairment. These parameters were compared with analysis of variance (ANOVA) and subsequent pairwise comparisons with an unadjusted analysis as well as a multivariate analysis that adjusted for age, sex, and body mass index. Patients were followed for a mean of 7 months after surgery (range, 3–12 months) for possible incision-related complications. No patents were lost to followup. Results Running subcuticular closure demonstrated the best overall perfusion. Mean incision perfusion in fluorescent units with SD was as follows: running subcuticular, 64 (16); vertical mattress, 32 (18); and staples, 19 (7) (ANOVA p < 0.001). The running subcuticular closure demonstrated the least impairment of perfusion among the closures compared. Mean perfusion impairment was as follows: running subcuticular, 21 (12); vertical mattress, 37 (24); and staples, 69 (27) (ANOVA p < 0.001). All Tukey-adjusted pairwise comparisons from both metrics likewise favored the subcuticular closure (p < 0.001) both before and after adjusting for age, sex, and body mass index. One patient in the vertical mattress cohort experienced a surgical site infection; no other wound-related complications were observed in this study. Conclusions The method of closure can influence skin and soft tissue perfusion after TKA. Running subcuticular closure enables the most physiologic robust blood flow, which may improve wound healing. However, the clinical importance of these findings remains uncertain, because patients in this study were selected because they lacked risk factors for wound healing complications. Studies with this modality in specific patient populations at higher risk for wound complications will be necessary to quantify the clinical advantage of using running subcuticular closure. Level of Evidence Level I, therapeutic study.

Trans-abdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repairs are the available surgeries for inguinal hernias, with both methods of laparoscopic repairs requiring mesh applications. This study analyzes the correlation between sutured versus stapler mesh fixation in a laparoscopic TAPP for unilateral groin hernia regarding chronic pain during 3-year follow-up. A total of 130 patients with laparoscopic hernia undergoing TAPP repair were randomized into 2 groups based on their fixation technique—one with sutures and the other with stapler. Postoperative complications and chronic groin pain were noted for each technique. Equal number of participants was present in the stapler and suture groups, with the majority having an ASA score of one. The mean age was 42.50 ± 13.86 years, and the body mass index (BMI) was 27.47 ± 5.88. The stapler group presented a shorter mean operative time than the suture group. However, the stapler group had a significantly higher mean VAS score than the suture group. Most participants in the suture group (89.2%) had LOS for 1 day, while a 2-day LOS was significantly higher in the stapler group (12.3%) than in the suture group (9.2%). No patient reported mesh erosion, conversion, recurrence, testicular atrophy, and mesh infection. Early postoperative pain was more in stapler group along with long hospital stay, but both were non-significant. Chronic postoperative pain results and recurrence incidences over 3-year follow-up were also similar. Re-admission rates were minimal, no significant complications occurred.

Background This study compared the results of stapled hemorrhoidopexy (SH) and harmonic scalpel hemorrhoidectomy (HSH) in the management of grade III and grade IV piles regarding the time of the procedure, postoperative pain, patient satisfaction, wound infection, bleeding, incontinence, and recurrence within 1 year. Patients and methods This was a single-blind, prospective, randomized, controlled, single-center trial conducted from January to December 2022 that included 50 (68.75%) male and 20 (31.25%) female patients with third- and fourth-degree piles. Results The patients were divided into two groups of 35 patients each. Group I underwent SH and group II underwent HSH. The mean age of group I was 42.94 years and of group II, 42.20 years. The mean time of the procedure was 24.42 min ± 2.367 for SH and 31.48 min ± 2.21 for HSH. Postoperative pain in group I was lower than in group II during the first 2 weeks, but there was persistent mild pain in most patients in group I at the 2‑week follow-up. In group II there was significant improvement in pain after 2 weeks, with higher patient satisfaction. Wound infection was detected in 3 (5%) patients in group I and no patients in group II ( p  = 0.077). Postoperative bleeding occurred in 4 (11.4%) patients in group I in the form of spotting after defecation only during the first postoperative month; no bleeding was detected in group II ( p  = 0.039). There were 3 (15%) cases of flatus incontinence but after taking a detailed history these were found to be cases of urgency to defecate rather than incontinence. There were 7 (20%) cases of recurrence at the 1‑year follow-up in group I and 1 (2.9%) case in group II ( p  = 0.024). Conclusion Compared with SH, HSH was safer, easier, and associated with a lower incidence of recurrence after 1 year and with higher patient satisfaction.

Staples have been widely used for skin closure after open gastrointestinal surgery. The potential advantages of subcuticular sutures compared with staples have not been assessed. We assessed the differences in the frequency of wound complications, including superficial incisional surgical site infection and hypertrophic scar formation, depending on whether subcuticular sutures or staples are used. We did a multicentre, open-label, randomised controlled trial at 24 institutions between June 1, 2009, and Feb 28, 2012. Eligible patients aged 20 years or older, with adequate organ function and undergoing elective open upper or lower gastrointestinal surgery, were randomly assigned preoperatively to either staples or subcuticular sutures for skin closure. Randomisation was done via a computer-generated permuted-block sequence, and was stratified by institution, sex, and type of surgery (ie, upper or lower gastrointestinal surgery). Our primary endpoint was the incidence of wound complications within 30 days of surgery. Analysis was done by intention to treat. This study is registered with UMINCTR, UMIN000002480. 1080 patients were enrolled and randomly assigned in a one to one ratio: 562 to subcuticular sutures and 518 to staples. 1072 were eligible for the primary endpoint and 1058 for the secondary endpoint. Of the 558 patients who received subcuticular sutures, 382 underwent upper gastrointestinal surgery and 176 underwent lower gastrointestinal surgery. Wound complications occurred in 47 of 558 patients (8·4%, 95% CI 6·3–11·0). Of the 514 who received staples, 413 underwent upper gastrointestinal surgery and 101 underwent lower gastrointestinal surgery. Wound complications occurred in 59 of 514 (11·5%, 95% CI 8·9–14·6). Overall, the rate of wound complications did not differ significantly between the subcuticular sutures and staples groups (odds ratio 0·709, 95% CI 0·474–1·062; p=0·12). The efficacy of subcuticular sutures was not validated as an improvement over a standard procedure for skin closure to reduce the incidence of wound complications after open gastrointestinal surgery. Johnson & Johnson.

Background The incisional surgical site infection (SSI) is an extremely common complication following open abdominal surgery and imposes a considerable treatment and cost burden. Method We conducted a multicenter open-label randomized controlled trial at three Tokyo Metropolitan medical institutions. We enrolled adult patients who underwent either an elective or an emergency open laparotomy. Eligible patients were allocated preoperatively to undergo wound closure with either subcuticular sutures or staples. A central Web-based randomization tool was used to assign participants randomly by a permuted block sequence with a 1:1 allocation ratio and a block size of 4 before mass closure to each group. The primary endpoint was the occurrence of a superficial SSI within 30 days after surgery in accordance with the Centers for Disease Control and Prevention criteria. This trial was registered with UMIN-CTR as UMIN 000004836 ( http://www.umin.ac.jp/ctr ). Results Between September 1, 2010 and August 31, 2015, 401 patients were enrolled and randomly assigned to either group. One hundred and ninety-nine patients were allocated to the subcuticular suture and 202 patients to the staple groups (hereafter the “suture” and “staple” group, respectively). Three hundred and ninety-nine were eligible for the primary endpoint. Superficial SSIs occurred in 25 of 198 suture patients and in 27 of 201 staple patients. Overall, the rate of superficial SSIs did not differ significantly between the suture and staple groups. Conclusion Subcuticular sutures did not increase the occurrence of superficial SSIs following open laparotomies mainly consisting of clean-contaminated surgical procedures. The applicability of the wound closure material and method is likely to depend on individual circumstances of the patient and surgical procedure.