1.Risk Analysis and Study of Post-marketing Adverse Events for Absorbable Sutures.
Yan WU ; Xiaoqing SUN ; Xuelei GONG ; Dong LI ; Ye ZENG ; Jianbing YIN
Chinese Journal of Medical Instrumentation 2023;47(5):571-575
Objective To investigate, analyze, and evaluate the risk data associated with the clinical use of absorbable sutures by retrieving and summarizing information from the databases of the US FDA and CNKI, as well as the adverse event reports related to absorbable sutures from January 2019 to October 2022 within Zhejiang province. The adverse event reports are obtained from both incident locations and monitoring organizations affiliated with the registrant. The aim is to identify the main risk factors associated with the clinical use of absorbable sutures. The key risk factors are potential product quality defects, product design and material selection, clinical selection and application, and postoperative recovery care including patient's self-care. Risk control strategies are further proposed to reduce or minimize the risk of adverse events caused by this product.
Humans
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Sutures/adverse effects*
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Risk Assessment
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Risk Factors
2.A two-stitch continuous suture method for single-lumen ileostomy.
Qing Nan LAN ; Jin Long YU ; Jie YU ; Gui Zhi LUO ; Qi ZOU ; Zhao Wei ZOU
Chinese Journal of Gastrointestinal Surgery 2022;25(11):1020-1024
Objective: To explore the value of a two-stitch continuous suture in single- lumen ileostomy. Methods: This was a retrospective cohort study. Data for 98 patients who underwent single-lumen enterostomy were retrospectively collected between 1 January 2021 and 1 May 2022 at Zhujiang Hospital of Southern Medical University. All patients met the indications for prophylactic single-lumen ileostomy. Those older than 80 years of age, with complex underlying diseases, extremely poor systemic conditions who could not tolerate surgery, poor blood supply at the end of the bowel, and severe edema or severe infection at the end of the bowel were excluded. Among the included patients, patients who underwent surgery before 1 October 2021 underwent ileostomy with interrupted suture (control group, n=60), and patients operated on and after 1 October 2021 routinely underwent two-stitch continuous suture ileostomy (two-stitch stoma group, n=38). Two-stitch continuous suture ileostomy is performed as follows: the first continuous suture is used to suture the intestinal seromuscular layer, peritoneum, posterior sheath, and anterior sheath from deep to superficial layers. The bowel wall is then opened. The second continuous suture is used to suture the full thickness of the bowel and the skin. The differences in postoperative ostomy-related complications and operation time were compared between the groups. Results: There were no significant differences in baseline data between the groups (all, P>0.05). The operative time in the two-stitch stoma group was shorter than that of the control group (16.6±2.2 minutes vs. 25.1±2.4 minutes, respectively; t=-17.874;P<0.001). The incidences of mucocutaneous separation, dermatitis, and stoma rebound in the two-stitch stoma group were lower than those of the control group [5.3% (2/38) vs. 31.7% (19/60), χ2=9.633, P=0.002;5.3% (2/38) vs. 28.3% (17/60), χ2=7.923, P=0.005; and 2.6% (1/38) vs. 18.3% (11/60), P=0.026, respectively], while the incidences of parastomal hernia and stoma prolapse, and the postoperative visual analog scale scores in the two groups were similar (all P>0.05). Conclusion: Compared with traditional single-lumen ileostomy, two-stitch continuous suture ileostomy has the advantages of short operation time, simplicity, esthetic appearance of the stoma, and a significant reduction in the postoperative complications associated with ileostomy.
Humans
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Ileostomy/adverse effects*
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Retrospective Studies
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Suture Techniques/adverse effects*
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Surgical Stomas
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Sutures/adverse effects*
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Postoperative Complications/epidemiology*
3.A Common Bile Duct Stone formed by Suture Material after Open Cholecystectomy.
Kook Hyun KIM ; Byung Ik JANG ; Tae Nyeun KIM
The Korean Journal of Internal Medicine 2007;22(4):279-282
The use of non-absorbable suture materials for cystic duct ligation after cholecystectomy can expose patients to the risk of recurrent stone formation in the common bile duct (CBD). However, in Korea suture materials have rarely been found to act as a nidus for common bile duct calculus formation. Recently, we experienced a case in which suture material, that had migrated from a previous cholecystectomy site into the CBD, probably served as a nidus for common bile duct stone formation. The stone was confirmed by endoscopic retrograde cholangiopancreatography (ERCP) and removed successfully using a basket. The authors report a case of surgical suture migration and discuss its subsequent role as a stone forming nucleus within the CBD in a patient who underwent open cholecystectomy; and include a review of the literature.
Aged
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Cholangiopancreatography, Endoscopic Retrograde
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Cholecystectomy/*adverse effects
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Foreign Bodies/*complications
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Foreign-Body Migration/*complications
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Gallstones/*etiology/surgery
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Humans
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Male
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Risk Factors
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Surgical Instruments
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Sutures/*adverse effects
4.Application of purse-string suture for management of duodenal stump in radical gastrectomy.
Qin-Shu SHAO ; Yong-Xiang WANG ; Zai-Yuan YE ; Zhong-Kuo ZHAO ; Ji XU
Chinese Medical Journal 2011;124(7):1018-1021
BACKGROUNDGastric cancer (GC) is the second leading cause of cancer mortality worldwide, and surgical resection is currently the only possible curative approach. Duodenal stump leakage is the most serious complication after radical gastrectomy, and optimal treatment is still lacking.
METHODSWe retrospectively reviewed 2034 cases of total or subtotal gastrectomy for GC from January 1995 to December 2009, including 465 cases of duodenal stump closure using purse-string suture (group A), 835 cases of duodenal stump treated with linear cutting stapler and seromuscular layer suture (group B), and 734 cases of duodenal stump closure using full-thickness and seromuscular layer suture (group C). We evaluated the surgical cost, operative time for duodenal stump closure, short-term postoperative complications, perioperative blood loss, and postoperative recovery.
RESULTSThere was no perioperative mortality in any group. Ninety-four postoperative (within 1 month) complications occurred: 18 abdominal bleeding, 14 anastomotic leakage, 15 abdominal infection, 36 wound infection, and 11 duodenal stump leakage. There was no significant difference among the groups in intra-abdominal hemorrhage, anastomotic leakage, abdominal infection and wound infection. No postoperative duodenal stump leakage occurred in group A, which had a significant difference compared with groups B and C (6 cases in group B and 5 cases in group C suffered duodenal stump leakage. P < 0.01). The surgical cost in groups A and C was significantly lower than in group B (P < 0.01), with no significant difference between groups A and C. The processing time for duodenal stump closure in groups A and B was significantly shorter than in group C (P < 0.01), with no significant difference between groups A and B. There was no significant difference in blood loss and postoperative recovery among the groups.
CONCLUSIONSDuodenal stump closure using purse-string suture seems to be a promising approach with shorter operative time, and lower cost and incidence of duodenal stump leakage in radical gastrectomy.
Aged ; Female ; Gastrectomy ; adverse effects ; methods ; Gastric Stump ; surgery ; Humans ; Male ; Middle Aged ; Postoperative Complications ; surgery ; Retrospective Studies ; Sutures
5.Foreign body granulomas in the left main bronchus resulting from the sutures for esophageal cancer surgery: the report of two cases.
Yang JIAO ; Yan SHANG ; Qiang LI ; Yang WANG ; Ning WU ; Qin WANG ; Xiang-Qi WANG ; Ying XIA
Chinese Medical Journal 2012;125(15):2764-2767
In this report, we present two cases of bronchial foreign body granulomas caused by the suture ties used in bronchial surgery for esophageal cancer. Both of them was hospitalized as "tumor transfer or an invasion", but pathological examination of the neoplasms indicated an inflammatory granuloma showing reaction to the foreign body. These two cases give us an attention that the neoplasms in tracheal or bronchial was not only the invasion or transfer of the primary tumor, but also the possibility of granuloma development due to the surgical sutures.
Bronchial Neoplasms
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etiology
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Esophageal Neoplasms
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surgery
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Granuloma, Foreign-Body
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etiology
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Humans
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Male
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Middle Aged
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Postoperative Complications
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Sutures
;
adverse effects
6.Application of three-stitch preventive transverse colostomy in anterior resection of low rectal cancer.
Yuzhou ZHAO ; Guangsen HAN ; Mingke HUO ; Li WEI ; Qiyun ZOU ; Yuji ZHANG ; Jian LI ; Yanhui GU ; Yanghui CAO ; Shijia ZHANG
Chinese Journal of Gastrointestinal Surgery 2017;20(4):439-442
OBJECTIVETo explore the application of three-stitch preventive transverse colostomy in anterior resection of low rectal cancer.
METHODFrom May 2015 to March 2016, 70 consecutive low rectal cancer patients undergoing anterior resection and preventive transverse colostomy in our department were recruited in this prospective study. According to the random number table method, 70 patients were divided into three-stitch transverse colostomy group(observation group, n=35) and traditional transverse colostomy group(control group, n=35). Procedure of three-stitch preventive transverse colostomy was as follows: firstly, at the upper 1/3 incision 0.5-1.0 cm distance from the skin, 7# silk was used to suture from outside to inside, then the needle belt line went through the transverse edge of the mesangial avascular zone. At the lower 1/3 incision 0.5-1.0 cm distance from the skin, 7# silk was used to suture from inside to outside, then silk went through the transverse edge of the mesangial avascular zone again and was ligatured. Finally, in the upper and lower ends of the stoma, 7# silk was used to suture and fix transverse seromuscular layer and the skin. The operation time and morbidity of postoperative complications associated with colostomy were compared between two groups.
RESULTSThere were no significant differences in baseline data between the two groups(all P>0.05). The operative time of observation group was shorter than that of control group [(3.2±1.3) min vs. (15.5±3.4) min, P<0.05]. Incidences of colostomy skin-mucous separation, dermatitis, stoma rebound were significantly lower in observation group [5.7%(2/35) vs. 34.3%(12/35), P=0.007; 8.6%(3/35) vs. 31.4%(11/35), P=0.036; 0 vs. 17.1%(6/35), P=0.025, respectively], while incidences of parastomal hernia and stoma prolapse in two groups were similar (both P>0.05).
CONCLUSIONCompared with traditional transverse colostomy method, the three-stitch preventive transverse colostomy has more operating advantages and can reduce postoperative complications associated with colostomy.
Colostomy ; adverse effects ; methods ; Comparative Effectiveness Research ; Humans ; Operative Time ; Postoperative Complications ; epidemiology ; Prospective Studies ; Rectal Neoplasms ; surgery ; Surgical Stomas ; adverse effects ; Suture Techniques ; adverse effects ; instrumentation ; Sutures ; Treatment Outcome
7.Suture Granuloma Mimicking Recurrent Thyroid Carcinoma on Ultrasonography.
Yong Eun CHUNG ; Eun Kyung KIM ; Min Jung KIM ; Mijin YUN ; Soon Won HONG
Yonsei Medical Journal 2006;47(5):748-751
Although high resolution ultrasonography (US) is helpful in the differentiation of suture granulomas from recurrent thyroid cancer in most cases, a definite diagnosis cannot always be made. We report a case that mimicked recurrent thyroid cancer on US and 2-[fluorine-18] fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET), but diagnosis of a suture granuloma was confirmed by a US-guided fine needle aspiration biopsy (FNAB). In order to avoid unnecessary operations, the differential diagnosis between postoperative suture granulomas and recurrent cancer is important.
Thyroidectomy/*adverse effects
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Thyroid Neoplasms/diagnosis/pathology/ultrasonography
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Sutures/*adverse effects
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Positron-Emission Tomography
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Neoplasm Recurrence, Local/diagnosis/pathology/ultrasonography
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Humans
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Granuloma, Foreign-Body/*diagnosis/etiology/ultrasonography
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Female
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Diagnosis, Differential
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Biopsy, Fine-Needle
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Adult
8.Suture menisci with epidural transfixion pin to treating acute meniscus tear under arthroscope.
Guang YANG ; Yun-miao MA ; Tie-feng XU ; Zhi-yang GAO
China Journal of Orthopaedics and Traumatology 2009;22(4):291-293
OBJECTIVETo study the utility and effect of suturing menisci with epidural transfixion pin to treating acute meniscus tear under arthroscope.
METHODSTwenty-two cases with acute meniscus tear were selected, in which 18 were male and 4 were female,aged from 17 to 42 years with average of 28.5. The tearing menisci were sutured with epidural transfixion pin and unabsorbed suture. The follow-up were 6-12 months after operation. Meanwhile, Lysholm score, subjective symptoms and examination were recorded.
RESULTSPreoperative Lysholm scores were 46.72 +/- 13.46, whereas, postoperative ones were 89.43 +/- 18.21. There was significant difference between before and after operation (t = 1.85, P < 0.01). No recurrent interlocking, no pain in joint medialis and post-medialis space. McMurray test was negative. The complications about injury of blood vessel, nerves and tendons were not found during 6-12 months follow-up.
CONCLUSIONThe technique is advantageous in convenience, reliability, large suture strength and definite curative effect.
Adolescent ; Adult ; Bone Nails ; Endoscopy ; adverse effects ; Epidural Space ; Female ; Humans ; Male ; Menisci, Tibial ; surgery ; Postoperative Complications ; Sutures ; Tibial Meniscus Injuries ; Treatment Outcome
9.Modified circumcision with a disposable suture device.
National Journal of Andrology 2015;21(6):541-544
OBJECTIVETo improve the methods and reduce the complications of circumcision with a disposable suture device.
METHODSThis study included 325 male patients aged 14-65 (mean 28.9) years, treated for redundant prepuce or phimosis by modified (n = 201) or conventional circumcision with a disposable suture device (n = 124). We compared the incidence of complications and the patients' satisfaction between the two surgical methods.
RESULTSCompared with conventional circumcision, the modified method showed a significantly lower incidence of postoperative bleeding (14.52% vs 2.49% , P < 0.05) and a lower rate of second surgery for penile hematoma (4.03% vs 0.50%, P < 0.05). The patients' satisfaction was markedly higher with the modified method (91.94%) than with conventional circumcision (97.51%) (P < 0.05).
CONCLUSIONModified circumcision with the disposable suture device can significantly reduce the incidence of postoperative bleeding and penile hematoma and therefore deserves wide clinical application.
Adolescent ; Adult ; Aged ; Circumcision, Male ; adverse effects ; instrumentation ; Disposable Equipment ; Humans ; Incidence ; Male ; Middle Aged ; Patient Satisfaction ; Penis ; surgery ; Phimosis ; surgery ; Postoperative Complications ; epidemiology ; Suture Techniques ; instrumentation ; Sutures
10.Cosmetic outcome and surgical site infection rates of antibacterial absorbable (Polyglactin 910) suture compared to Chinese silk suture in breast cancer surgery: a randomized pilot research.
Zhong-Tao ZHANG ; Hong-Wei ZHANG ; Xue-Dong FANG ; Li-Ming WANG ; Xiao-Xi LI ; Ya-Fen LI ; Xiao-Wei SUN ; Judith CARVER ; Dorella SIMPKINS ; Jessica SHEN ; Martin WEISBERG
Chinese Medical Journal 2011;124(5):719-724
BACKGROUNDThe primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy. A secondary objective was to assess the incidence of surgical site infection (SSI).
METHODSPatients undergoing modified radical mastectomy were randomly assigned to coated VICRYL Plus antibacterial (Polyglactin 910) suture or Chinese silk suture. Cosmetic outcomes were evaluated postoperatively at days 12 (± 2) and 30 (± 5), and the evidence of SSI was assessed at days 3, 5, 7, 12 (± 2), 30 (± 5), and 90 (± 7). Cosmetic outcomes were independently assessed via visual analogue scale (VAS) score evaluations of blinded incision photographs (primary endpoint) and surgeon-assessed modified Hollander Scale (mHCS) scores (secondary endpoint). SSI assessments used both CDC criteria and ASEPSIS scores.
RESULTSSix Chinese hospitals randomized 101 women undergoing modified radical mastectomy to closure with coated VICRYL Plus suture (n = 51) or Chinese silk suture (n = 50). Mean VAS cosmetic outcome scores for antibacterial suture (67.2) were better than for Chinese silk (45.4) at day 30 (P < 0.0001)). Mean mHCS cosmetic outcome total scores, were also higher for antibacterial suture (5.7) than for Chinese silk (5.0) at day 30 (P = 0.002).
CONCLUSIONSPatients using coated VICRYL Plus suture had significantly better cosmetic outcomes than those with Chinese silk sutures. Patients using coated VICRYL Plus suture had a lower SSI incidence compared to the Chinese silk sutures, although the difference did not reach statistical significance.
Anti-Bacterial Agents ; therapeutic use ; Breast Neoplasms ; surgery ; Female ; Humans ; Mastectomy ; adverse effects ; Polyglactin 910 ; therapeutic use ; Silk ; therapeutic use ; Surgical Wound Infection ; microbiology ; Sutures ; Treatment Outcome