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Ruptured suture at the anastomosis site [anastomotic leak].Case narrative: initial information received on 31-jan-2020 regarding a solicited valid serious case received from (b)(6)-pcp under reference on 31-jan-2020 and transmitted to sanofi, in the scope of post-marketing sponsored study.Title: preventive effects of a synthetic absorbable antiadhesive film (seprafilm) on small bowel obstruction in patients who underwent elective surgery for colon cancer: a randomized controlled trial.Author: saito g, sadahiro s, ogimi t, miyakita h, okada k, tanaka a, et al.Journal: journal of surgical oncology, 2019, 120, 1-6.Patient id: unk; country: (b)(6).Study title: unsponsored study involving seprafilm.This case was issued in publication in which 3 other related cases were reported: (b)(4) (cluster).This case involves a (b)(6) years old male patient (160 cm and (b)(6)) who experienced ruptured suture at the anastomosis site, while he was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included sigmoidectomy on (b)(6) 2009.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing rectosigmoid cancer and was a tobacco user.Notes: inpatient.[patient's background]: preoperative concurrent condition: none, historical condition: none.Diabetes mellitus: none, allergy predisposition: none.History of surgery: none, smoking: presence (20 cigarettes/day).[before surgery]: underlying disease: rectosigmoid cancer.[patient's condition]: preoperative condition: generally healthy with good nutrition, anemia: none, radiotherapy: none.[during surgery]: date of admission: (b)(6) 2009, date of discharge: (b)(6) 2009, date of surgery: (b)(6) 2009, elective surgery.Operative method/reconstruction method: low anterior resection, hyperthermic treatment during surgery: none.Use of seprafilm: placing site: immediately below midline wound, infection at the placing site: none direct placing to the anastomosis site: none, number of the sheet: 2 sheets, placing condition: good, the surgeon's use experience of seprafilm: presence.Condition of the surgery: s-rs resection, immediately below midline wound, ruptured suture, drain in the pelvis site of placement of drain: presence (kind of drain: dual drain).Existing adhesion: none, exfoliation: none.Abdominal cavity: existing non-purulent inflammation: none, existing infection: none, interperitoneal lavage: presence (3l).Anastomosis of the resected parts: excision site: presence (s-rs), existing non-purulent inflammation: none, existing infection: none, method of anastomosis at the excision site: machine.Ligature (kind): absorbable, multi (name: 3-ovicny).Suture of abdominal incision: abdominal incision.Length of abdominal incision: 25 cm, suture layer: 2 layers.Suture method of the first layer (peritoneum layer): knotted suture, suture thread: absorbable, mono, name: opds.Suture method of the skin layer: manually sutured (knotted suture) - suture thread: absorbable, mono, name: 4-opds.Existing non-purulent inflammation: none, existing infection: none.Surgery time: about 1.5 hours, amount of bleeding: 100 g, blood infusion: none.After surgery: concomitant use of other medical devices: none.[examination/treatment for the adverse events]: bacterial test: not performed.Infection/inflammation-related laboratory tests: white blood count: 11900, crp: 0.2 (date of test: (b)(6) 2009).Prolongation of hospitalization period: presence.Re-hospitalization for treatment: none.Re-laparotomy: none.Concomitant medications included flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis.On an unknown date, 2 sheets of seprafilm (lot number: unknown) were used for after low anterior resection (after s-rs resection).On (b)(6) 2009, radiographic contrast study showed ruptured suture, which then improved with conservative management.On (b)(6) 2009, the patient was discharged from the hospital.Then, sbo (adhesive small bowel obstruction) was observed.The ruptured suture at the anastomosis site resolved.The patient developed an event of a serious ruptured suture at the anastomosis site after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: c-reactive protein - on (b)(6) 2009: 0.2 [0.2].White blood cell count - on (b)(6) 2009: 11900 [11900].X-ray - on an unknown date: [ruptured suture at the anastomosis site].Final diagnosis was ruptured suture at the anastomosis site.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on (b)(6) 2009 for ruptured suture at the anastomosis site.Anastomotic leak is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: causal relationship of the ruptured suture at the anastomosis site to seprafilm: possible.Other possible factors suspected as the cause of the ruptured suture at the anastomosis site: the patient's risk factors (concurrent condition, historical condition, age, and others), operative stress, concomitant drugs, and concomitant medical devices (including suture thread and drain).Comment on the causal relationship of the ruptured suture at the anastomosis site to seprafilm: none.
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