MEDICOLEGAL REPORT
Prepared for the Court
Claimant:Mrs A
Address:Unspecified
Date of Birth:1958
Occupation:Housewife
Date of Accident:15 February 2005
Examining Doctor:Dr D
Consultant Obstetrician and Gynaecologist
Statement of Instruction
This report is prepared on behalf of the defendant, Dr D in connection with the complications following treatment of Endometriosis on Mrs A started from 23 April 2003.
Case Summary
Mrs A has suffered complications from foecal peritonitis and pulmonary embolism following the procedures of total abdominal hysterectomy and bilateral salpingo-oophorectomy for the treatment of endometriosis.
Case Details
Mrs A was referred by her GP and attended the clinic on 23rd April 2003. Mrs A was complaining of constant, severe abdominal pain, per vaginal bleeding with irregular cycles for 2 months with a background history of tubal ligation in 1999. Dr D was unsure of the diagnosis as to whether it was due to endometriosis, polycystic ovarian disease, or tubal infection associated with the previous tubal ligation. Therefore Mrs A was admitted, prescribed with painkiller (Pethidine), and booked for laparoscopy the next day.
The result of laparoscopy confirmed active endometriosis with 2 small fibroids and medical treatment of GnRH analogue (Zoladex) was discussed with Mrs A and agreed. Mrs A treatment was then to be reviewed in November 2003.
On 5th November 2003, Mrs A attended the clinic and her medication was changed from GnRH analogue to Medroxyprogesterone acetate (Provera).
On review in 4th February 2004, Mrs A was not happy with Provera and the prescription was reverted back to Zoladex.
On review in 14th July 2004, side effects due to prolonged use of Zoladex were explained and she agreed to start on combined oral contraceptive pills (COCP).
On 24th Novemeber 2014, Mrs A came in complaining of severe pain not resolved with COCP and painkiller. Surgical treatment was discussed and she was booked for operation for the removal of uterus, cervix, Fallopian tubes, and ovaries called “Total Abdominal Hysterectomy and Bilateral Salpingo-Oophorectomy (TAH/BSO)” in February 2005 and for the meanwhile she was also prescribed with non-steroidal anti-inflammatory drug – Mefenamic acid (Ponstan) and an opioid analgesics – tramadol (Zydol) to relieve the pain.
On 15th February 2005, Mrs A was admitted to the hospital for TAH/BSO.
On 16th February 2005, Mrs A complained of pleuritic chest pain, shortness of breath, fever, and sweating. On examination she was tachycardic, and on auscultation, there were coarse crackles on the right base of the lung and fine crackles on the left base. She was commenced on antibiiotics without delay – ciprofloxacin and gentamycin together with an anticoagulant low molecular weight heparin – Innohep post-surgery.
On 17th February 2005, CT pulmonary angiogram confirmed pulmonary embolism on the right side with possibility on the left side. She was commenced on warfarin and Innohep was continued until INR stabilized.
On 18th February 2005, Mrs A complained of non-pleuritic chest pain, numbness going down on the left arm and up into the neck, and tenderness over the left axilla. Cultures showed positive Gram negative coccobacili. Antibiotics treatment was continued and respiratory consult was obtained.
On 21st February 2005, cultures showed anaerobic organism that usually comes from the gut – Prevotella loescheii. The antibiotic course was changed to include metronidazole.
On 23rd February 2005, radiology report confirmed the diagnosis of foecal peritonitis. Stomatherapy was discussed and anaesthetic consult was obtained. This was day 9 post-TAH/BSO and Hartmann procedure was done to treat the peritonitis.
On 24th February 2005, antibiotic treatment of cephalosporin (Cephradine), metronidazole, and gentamycin were continued.
The Results of Investigation
Mrs A was diagnosed endometriosis through laparoscopy and 2 small fibroids were also found. It was confirmed from the histopathology report.
Pulmonary embolism was diagnosed through radiological findings on CTPA and increased in D-dimer while sepsis was identified from the blood culture.
Peritonitis was suspected from the finding of anaerobes on culture and clinical signs and symptoms together with CT scan of the abdomen formed the diagnosis of foecal peritonitis.
The Nature of Treatments Received by the Claimant
Endometriosis
When Mrs A first diagnosed with endometriosis, she was treated by medical treatments – GnRH analogue for 6 months, then changed to Medroxyprogesterone for the next 4 months, back to GnRH analogue for another 6 months afterwards, and changed to Combined OCP. Mrs A condition was getting worse and surgical option of TAH/BSO was decided.
Pulmonary Embolism (PE) and Sepsis
Mrs A was prescribed with antibiotics and anticoagulant when lower respiratory tract infection or PE was suspected. When PE was confirmed, she was already on anticoagulant (Innohep). Warfarin was prescribed after the diagnosis made and antibiotics were continued due to suspected pneumonia or sepsis. The next day, blood culture result was out and confirmed positive.
Peritonitis
Mrs A was suspected of having sepsis and once culture showed the presence of anaerobes from the gut (Prevatella loescheii), metronidazole was prescribed to cover the anaerobic bacteria. When bowel perforation and foecal peritonitis were confirmed, surgery was carried out to clean up the abdominal cavity. Antibiotics, painkiller, and anticoagulant were continued post-surgery.
Opinion on the Patient Management
It was a regretful incident that Mrs A suffered complication from peritonitis secondary to bowel perforation, either secondary to adverse event where the operating surgeon unintentionally cut the bowel or due to advanced endometriosis. My review of the managements of this patient from her initial presentation of endometriosis are they are evidence-based, performed in a timely manner, and displayed the knowledge and action of an experienced clinician, and that the complications aroused were less likely due to poor management of the patient.
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In 1999, Mrs A underwent a laparoscopic tubal ligation and during the operation, there was suspected retrograde menstruation found which may possibly suggest endometriosis. It was in 2003 that the patient was actually diagnosed with endometriosis. However, this could be common where there was delay between the onset of symptoms and the diagnosis of the disease. There is no difference in the delay in diagnosis between mild to moderate and severe endometriosis. In a comparison study conducted in UK and US, the average delay before the diagnosis of endometriosis was 7.5 years and this will likely decreases the women’s capability to cope with the symptoms in which they would present to the formal healthcare [Ruth Hadfield, 1996].
The clinical evaluation of Mrs A was done in a sufficient and timely manner as the diagnosis of endometriosis was suspected in the first presentation since this will usually require high index suspicion due to the wide variety of symptoms and unpredictable course of disease (Lobo, 2007). Video-assisted laparoscopy was also carried out in the second day of admission showing that the clinician involved has a very high suspicion index of endometriosis from the beginning, as laparoscopy is the gold standard to reach a definitive diagnosis of endometriosis. [Bagan et al, 2003]
The approach of the management of endometriosis was done properly and the choice of medical treatment as opposed to surgical treatment is wise. Unlike surgery for cancer, Adamson GD (1997) and Sutton et al (1997) said that in the case of endometriosis, surgery is relatively more effective for severe endometriosis rather than in mild cases such as in those with chronic pelvic pain and infertility and because of that, medical treatment is much preferable in the first presentation of endometriosis apart from it being non-invasive. A Canadian study of more than 53 000 admissions showed that 25% patients who had surgical treatment would need another surgery within 4 years and 10% would require hysterectomy and therefore, continual medical management is much preferred over serial surgeries [Weir et al, 2005].
Alifano (2003) mentioned that the prescription of GnRH analogue is recommended as it may have both diagnostic and therapeutic values. The prescription of not more than 6 months in this case was also supported by clinical literatures and Royal College of Obstetrician and Gynaecology (RCOG) guideline as the treatment may result in loss of 6% bone mineral density in the first 6 months [RCOG, 2006]. Extended treatment may result in further loss of bone minerals. Falcone (2011) recommended the commencement of combined oral contraceptive pills (COCP) following the cessation of GnRH analogue and therefore, the choice of COCP after GnRH analogue in this case was also supported by clinical evidence. Shakiba et al (2008) also described the usage of COCP as cost-effective, well tolerated, and clinically effective as danazol and GnRH analogue.
The medical treatment is initially acceptable for this patient as earlier laparoscopy in June 2003 showed adhesions between the omentum and uterus with multiple spots of endometriosis and thick, stale, reddish green blood while the later microscopy findings in February 2005 showed well bordered white lesion and occasional white coloured spots that may be suggestive of healed or inactive lesions which should reduce the likelihood of invasive treatment. Brosens (1994) believed that the early and very active lesion would be in red, active and advanced lesion in black, and inactive or healed lesion in white, even though this might be varied from case to case.
It is worth to note that there is currently no cure for endometriosis as current treatments aim at symptoms relief such as pain and infertility and organ damage prevention in severe cases. There is no randomized clinical trial comparing medical with surgical treatments; therefore the change of medical to surgical treatment has its own advantages and disadvantages [Sally et al, 2013]. From the record, there was a gap between the patient presentation of severe pain not improving with painkiller and COCP to the last clinic before surgery in November 2004 and the booked surgery in February 2005. This may be justified by non-invasive over invasive management; for example managing the pain by prescribing stronger painkiller such as in this case, tramadol. Since there is no relationship between the severity of pain with the severity of endometriosis, short delay in deciding on hysterectomy or watchful waiting may be an advantage for the patient and the clinician as well to see if there would be any improvement. Apart from that, there was no guarantee that surgery may treat the endometriosis.
The decision of TAH/BSO was also recommended in this case as the preservation of one or both ovaries in some women may have left the problems with endometriosis behind. Whether the hysterectomy being subtotal or total, it would definitely improve the quality of life of this patient and thus should be considerable decision by the clinician. [Thakar et al, 2004]
Even though all precautions and preventive measures have been made, while incidence of internal organ injury is rare, however it does happen especially when the risk is higher in the patient with history of pelvic infection, endometriosis, and adhesive diseases [John, 1997]. However, considerations that need to be taken into account is whether the complications aroused were due to an adverse event such as bowel perforation from the surgery, expected complication arising from the condition such as secondary to adhesions from endometriosis, or the combination of both.
The risk of bowel perforation in this open abdominal surgery is much lowered compared to scope-assisted hysterectomy. Bowel injuries happen in about 0.2-1% of cases and primarily due to adhesions involving bowel or cutting within the pouch of Douglas – the space between rectum and uterus. Therefore, it was difficult to expect that this case was to be an addition to the 0.2-1% risk in the study. (Gary et al, 2004)
Infection is a common complication following abdominal hysterectomy carrying the risk of 6-25%. Above all, about 33% of patients develop infection after the operation regardless of careful precautions taken [Rice et al, 2006]. Other than infection, severe complications that may occur involve lung collapse, heart attack, stroke, kidney failure, and clotting in the blood vessel (ie pulmonary embolism- clot blockage in the lung) with 4% risk.
Greer (1997) mentioned that the risk of developing pulmonary embolism in patient following major general or gynaecologic surgery without clot prevention treatment (thromboprophylaxis) is very low at 0.2-0.9% while in another study, the risk of pulmonary embolism for patient receiving clot prevention treatment of anticoagulants is 0.2%. Therefore, this is a rare severe complication of abdominal hysterectomy that less expected to happen.
Despite psychological effects following hysterectomy and prolonged hospitalisation, patient has benefit from the improvement in the quality of life in longer term. And even though multiple complications resulted from the procedure, most women are quite satisfied with the results of the surgery and with the significant symptom relief they experience [Kjerulff et al, 2000].
Conclusion
Complications after surgery despite their rareness does happen and this was unexpected incident befall upon Mrs A. However, I believed Dr D, within his capabilities, has managed Mrs A with acceptable, sufficient, and evidence-based methods from the initial treatment until the last resort of hysterectomy to prevent any complications from happening.
Duty of an Expert
I understand my duty is to the Court; to help the Court on matters within my expertise, and I have complied with that.
I understand that this duty over-rides any obligations to those by whom I have been instructed.
I believe that the facts I have stated in the report are true and within my own knowledge and that the opinions I have expressed represent my professional opinion.
BIBLIOGRAPHY
Brosens I. Is mild endometriosis a progressive disease? Human Reproduction 1994; 9: 2209–2211.
Adamson GD. Treatment of endometriosis-associated infertility. Seminars in Reproductive Endocrinology 1997; 15: 263–271.
Sutton CJG, Pooley AS & Ewen SP. Follow-up report on a randomized, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild and moderate endometriosis. Fertility and Sterility 1997; 68: 170–174.
AstraZeneca. Zoladex 3.6mg Implant. Summary of Product characteristics. 2012.
Brown J, Pan A, Hart RJ. Gonadotrophin-releasing hormone analogues for pain associated with endometriosis. Cochrane Database of Systematic Reviews 2010, Issue 12. Art. No.: CD008475.
Falcone T. Lebovic DI. Clinical management of endometriosis. Obstetrics & Gynecology. 118(3):691-705, 2011 Sep.
RCOG. The investigation and management of endometriosis. Green-top guideline 24. 2006
Lobo R. Endometriosis: Etiology, Pathology, Diagnosis and Management. 5th ed. Katz VL, editor. Comprehensive Gynecology. Philadelphia, PA: Mosby Elsevier; 2007:473–499.
Alifano M, Roth T, Broet SC, Schussler O, Magdeleinat P, Regnard JF. Catamenial pneumothorax: a prospective study. Chest. 2003;124:1004–1008.
Bagan P, Le Pimpec Barthes F, Assouad J, Souilamas R, Riquet M. Catamenial pneumothorax: retrospective study of surgical treatment. Ann Thorac Surg. 2003;75:378–81; discusssion 81.
Weir E, Mustard C, Cohen M, Kung R. Endometriosis: What is the risk of hospital admission, readmission, and major surgical intervention? J Minim Invasive Gynecol 2005;12:486–93.
Shakiba K, Bena JF, McGill KM, Minger J, Falcone T. Surgical treatment of endometriosis: a 7-year follow up on the requirement for further surgery. Obstet Gynecol 2008;111: 1285–92.
John D Thompson. Operative Injuries to the Ureter: Prevention, Recognition, and Management. In: John A Rock and John D Thompson. Te Linde’s Operative Gynecology. Eighth. Philadelphia New York: Lippincott-Raven; 1997:Chapter 40 Pages 1135-1173.
Thakar R, Ayers S, Georgakapolou A, Clarkson P, Stanton S, Manyonda I. Hysterectomy improves quality of life and decreases psychiatric symptoms: a prospective and randomised comparison of total versus subtotal hysterectomy. BJOG. Oct 2004;111(10):1115-20.
Eskenazi B, Warner ML. Epidemiology of endometriosis. Obstet Gynecol Clin North Am. Jun 1997;24(2):235-258.
Wykes CB, Clark TJ, Khan KS. Accuracy of laparoscopy in the diagnosis of endometriosis: a systematic quantitative review. BJOG. Nov 2004;111(11):1204-1212.
Ruth H, Helen M, David B, Stephen K. Delay in diagnosis of endometriosis: a survey of women from the USA and the UK. Human Reproduction; 1996: vol.11 no.4 pages 878-880.
Kjerulff KH, Langenberg PW, Rhodes JC, et al. Effectiveness of hysterectomy. Obstet Gynecol. 2000;95:319-326.
Rice CN, Howard CH. Complications of hysterectomy. US Pharm. 2006; 31(9):HS-16-HS-24.
Greer IA. Epidemiology, risk factors and prophylaxis of venous thrombo-embolism in obstetrics and gynaecology. Baillieres Clin Obstet Gynaecol 1997; 11:403.
Garry R, Fountain J, Mason S, et al. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004; 328:129.
Mäkinen J, Johansson J, Tomás C, et al. Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod 2001; 16:1473.
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