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"Surgical Stapling - methods"
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Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial
by
Brown, Steven R
,
McDonald, Alison
,
Bruhn, Hanne
in
Adult
,
Clinical Protocols - standards
,
Comparative studies
2016
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.
Journal Article
Double stapling technique versus hemi-double stapling technique for esophagojejunostomy with OrVil™ after laparoscopic total gastrectomy: a single-blind, randomized clinical trial
by
Yoshimoto, Yutaro
,
Mine, Shinji
,
Yamauchi, Suguru
in
Chemotherapy
,
Clinical trials
,
Gastric cancer
2023
BackgroundThe transorally inserted anvil (OrVil™) is frequently selected for esophagojejunostomy after laparoscopic total gastrectomy (LTG) because of its versatility. During anastomosis with OrVil™, the double stapling technique (DST) or hemi-double stapling technique (HDST) can be selected by overlapping the linear stapler and the circular stapler. However, no studies have reported the differences between the methods and their clinical significance.MethodsA randomized controlled clinical trial with a parallel assignment and single-blind outcomes assessment analysis was conducted. Patients with gastric cancer eligible for LTG who met the selection criteria were randomized. Preoperative characteristics and perioperative and postoperative outcomes were compared between the DST and HDST. The primary endpoint was an anastomosis-related complication, and the secondary endpoints were perioperative outcomes and postoperative complications, excluding anastomosis-related complications.ResultsThirty patients with gastric cancer were eligible and randomized. LTG and esophagojejunostomy were successfully performed in all patients, without conversion to laparotomy. Preoperative characteristics, excluding preoperative chemotherapy, were not significantly different between the two groups. One anastomotic leakage of Clavien–Dindo classification grade ≥ IIIa was observed in the DST, although no significant difference was found between the two groups (6.6% vs. 0%, P = 0.30). In the HDST, one case of anastomotic stricture required endoscopic balloon dilation. No significant differences were found in operative time, whereas the anastomosis time was significantly shorter in the HDST than in the DST (47.5 ± 15.8 vs. 38.2 ± 8.8 min, P = 0.028). Except for anastomosis-related complications, postoperative complications (P = 0.282) and postoperative hospital stay for the DST and HDST were not significantly different.ConclusionsNo superiority was found between the DST and HDST with OrVil™ in esophagojejunostomy of LTG for gastric cancer with respect to postoperative complications, whereas the HDST may be preferable in terms of the simplicity of the surgical technique.
Journal Article
Comparison of surgical wound infection and dehiscence following the use of two methods of nylon sutures and skin staples in staples in diabetic mellitus patients undergoing total knee arthroplasty surgery: a randomized clinical trial study
by
Ahmadi, Mohammadamin
,
Doreh, Mina Amiri
,
Fereidouni, Armin
in
Aged
,
Analysis
,
Arthroplasty (knee)
2025
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.
Journal Article
Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial
2025
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
Journal Article
A randomized controlled trial of stapled versus ultrasonic transection in distal pancreatectomy
by
Esposito, Alessandro
,
Fontana Martina
,
Malleo Giuseppe
in
Abdomen
,
Authorship
,
Blood transfusions
2022
BackgroundThe pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy.MethodsPatients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay.ResultsOverall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2–20.0, p = 0.032).ConclusionThe present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.
Journal Article
Prospective, randomized and controlled study of mesh displacement after laparoscopic inguinal repair: fixation versus no fixation of mesh
2016
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.
Journal Article
A Randomized Comparison Between Staple-Line Oversewing Versus No Reinforcement During Laparoscopic Vertical Sleeve Gastrectomy
by
Abozeid, Mohamed
,
Abdelaal, Mahmoud
,
Taha, Osama
in
Comparative studies
,
Gastrointestinal surgery
,
Laparoscopy
2018
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.
Journal Article
Comparison of Early Postoperative Outcomes of Omentopexy and Clips along the Staple Line During Laparoscopic Sleeve Gastrectomy: A Randomized Study
by
Islam, Mehmet Muzaffer
,
Bacaksiz, Mehmet Erman
,
Sisik, Abdullah
in
Adult
,
Anticoagulants
,
Blood pressure
2024
Background
We aimed to compare the omentopexy and clipping reinforcement methods performed along the staple line during laparoscopic sleeve gastrectomy (LSG) in terms of the effectiveness on postoperative bleeding.
Methods
In this prospective randomized controlled study, patients were divided into two groups: clips group (CG) and omentopexy group (OG). The groups were compared in terms of postoperative bleeding, duration of surgery, length of hospital stay, hospital readmissions in the postoperative first 30-days.
Results
A total of 148 patients were included in the study. Postoperative bleeding was observed in 11 patients (14.9%) of CG and 2 patients (2.7%) of the OG, and the difference between the groups was found to be significant (
p
= 0.009). Similarly, the number of patients with bleeding that did not require intervention was 9 (12.2%) in CG and 2 (2.7%) in OG, and the difference between the groups was also significant (
p
= 0.028). The duration of surgery in the CG was 30 (27 to 36) minutes, whereas in the OG, it was 43 (39 to 45) minutes, with a significant difference noted (
p
< 0.001). Additionally, the rate of patients readmitted to the hospital within the first 30 days was 16 (21.6%) in the CG and 7 (9.5%) in the OG, with a significant difference observed (
p
= 0.041).
Conclusion
In terms of bleeding requiring intervention, there was no difference between omentopexy and clipping techniques. In addition, omentopexy showed more satisfactory results than clipping in terms of non-interventional bleeding, but its clinical significance is unclear.
Journal Article
Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial
by
Griessenauer, Christoph J
,
Sommer, Bjoern
,
Blume, Christian
in
Back surgery
,
Bone surgery
,
Epidemiology
2024
PurposeSuperficial surgical site infection (SSSI) is a prominent problem in spine surgery. Intracutaneous sutures and staple-assisted closure are two widely used surgical techniques for skin closure. Yet, their comparative impact on wound healing and infection rates is underexplored. Our goal was to address this gap and compare wound healing between these two techniques.MethodsThis study was a multicenter international prospective randomized trial. Patient data were prospectively collected at three large academic centers, patients who underwent non-instrumented lumbar primary spine surgery were included. Patients were intraoperatively randomized to either intracutaneous suture or staple-assisted closure cohorts. The primary endpoint was SSSI within 30 days after surgery according to the wound infection Centers for Disease Control and Prevention (CDC) classification system.ResultsOf 207 patients, 110 were randomized to intracutaneous sutures and 97 to staple-assisted closure. Both groups were homogenous with respect to epidemiological as well as surgical parameters. Two patients (one of each group) suffered from an A1 wound infection at the 30-day follow up. Median skin closure time was faster in the staple-assisted closure group (198 s vs. 13 s, p < 0,001).ConclusionThis study showed an overall low superficial surgical site infection rate in both patient cohorts in primary non instrumented spine surgery.
Journal Article
Comparing stapler and sutured mesh fixation techniques for laparoscopic TAPP repair: a study on chronic groin pain on 3-year follow-up
2024
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.
Journal Article