by Gracie Awalt, Marketing Associate, and
Kassie Toerner, Senior Risk Management Representative
Presentation
A 42-year-old woman came to see her obstetrician-gynecologist (Ob-Gyn A) on January 10 with abnormal uterine bleeding and abdominal and pelvic pain. She had been a patient of Ob-Gyn A for nine years.
The patient had a history of obesity, infertility, multiple laparoscopies, and an exploratory laparotomy. She had tubal obstruction bilaterally, extensive pelvic adhesive disease, fibroid uterus, and pelvic endometriosis.
Six years earlier, Ob-Gyn A performed a lysis of adhesions and bilateral fimbrioplasties on the patient. After these procedures, Ob-Gyn A documented that the patient had an extensive number of adhesions, and her cul-de-sac was obliterated by adhesions and endometriotic implants. The patient’s tubal function was not salvaged.
Physician action
During the January 10 office visit, an ultrasound revealed an enlarged uterus and several myomas within the uterine wall, the largest with a 9 cm diameter. Ob-Gyn A recommended a total vaginal hysterectomy (TVH) with a McCall culdoplasty (MC). After expressing her desire to retain her ovaries, the patient agreed to surgery scheduled on March 17.
On March 15, the patient returned to Ob-Gyn A for pre-surgery counseling. During this appointment, she expressed a desire for permanent sterilization and surgical management of her problems. After an assessment, Ob-Gyn A diagnosed the following:
- obesity;
- female infertility of tubal origin;
- status-post bilateral salpingectomies;
- pure hypercholesterolemia;
- endometriosis of pelvic peritoneum;
- intramural leiomyoma of uterus, symptomatic 14–16-week fibroids;
- secondary dysmenorrhea; and
- menorrhagia.
Ob-Gyn A discussed the diagnoses and planned procedures with the patient, answered questions, and provided literature. Informed consent was obtained, and the physician noted the desire for conservation of both ovaries, if possible. After giving the patient preoperative instructions and performing preoperative labs, the TVH and MC were scheduled, as well as a postoperative visit three weeks after the surgery.
On March 17, the procedures were successfully completed. Ob-Gyn A documented extensive adhesions and anatomic distortion, with the entire cul-de-sac having adhesions from the posterior fundus to the vaginal wall. Her ovaries were adherent to the pelvic sidewalls, and her enlarged uterus had to be bi-valved and excised in pieces. The largest myoma was 3.7 cm in diameter, and the uterine weight was 375 grams. The patient was discharged the same day.
The next day, the patient reported that she was doing well with normal urination and bowel movements. She was walking without dizziness and not experiencing hot flashes. However, the following day, the patient reported worsening abdominal pain, with no fever or vomiting. Ob-Gyn A instructed the patient to drink more fluids and eat less, since she was at risk for adynamic ileus.
Early the next morning on March 20, the patient started vomiting and went to a nearby emergency department (ED). She reported having no bowel movements since the surgery. After evaluation, she was determined to be septic with a bowel injury due to the large amount of free air within her abdomen; a swollen sigmoid colon; extraluminal debris presumed to be stool; and an elevated serum lactate level and serum creatinine level.
The patient was placed on an IV antibiotic and was suspected of having a perforated viscus. An on-call surgeon at the hospital, General Surgeon A, performed an exploratory laparotomy the same day at 6:43 a.m.
In the operative notes, General Surgeon A wrote: “extensive adhesions were encountered throughout her abdominal cavity and pelvis. Large amounts of formed stool and purulent fluid were also present throughout the same body cavities. A perforation of her sigmoid colon was detected, and a sigmoid colon resection was done, along with creation of a colostomy. Her tissues were inflamed and multiple collections of phlegmon were encountered. Her abdomen and pelvis were copiously irrigated, and she was transferred to the ICU postoperatively with mechanical ventilation still taking place.”
While in the ICU, the patient’s serum lactate rose to 5.8; her serum creatinine rose dangerously high; and she was oliguric. She was diagnosed with acute kidney injury and started on dialysis. Her blood pressure dropped to very low levels, and she continued to become progressively acidotic.
She received two different vasopressors to maintain pulse pressure, and she displayed evidence of pulmonary edema, acute respiratory distress syndrome, and myocardial suppression. An echocardiogram revealed the presence of mild left ventricular hypertrophy with decreased ejection fraction of 40 percent.
On March 22, the patient’s heart stopped. After two hours of CPR, she died at 7 a.m. The cause of death was “septic complications of iatrogenic bowel perforation during total abdominal hysterectomy.” An autopsy confirmed the cause of death to be respiratory failure, pulmonary edema, and septic complications. She had necrotic pelvis tissue; the colonic line of resection and the site of ostomy were intact.
Allegations
The patient’s family filed a lawsuit against Ob-Gyn A, the physician assistant (PA), and the surgery center where the procedures were performed.
Allegations included:
- negligence when performing a vaginal hysterectomy that resulted in bowel injury, sepsis, organ failure, and death;
- failure to use an initial laparoscopic approach to evaluate the patient’s level of adhesive disease before the TVH; and
- failure to mitigate the risk of intraoperative complications.
Legal implications
Expert consultants for the defense were not supportive of the care provided, and stated that Ob-Gyn A exhibited poor clinical judgement and decision-making.
One consultant believed Ob-Gyn A made decisions that led to poor visibility during surgery. Because the patient had not experienced childbirth and her uterosacral ligaments had not been stretched, it was very difficult for Ob-Gyn A to have proper visibility to clamp tissues and blood vessels at the right location when extracting the patient’s enlarged uterus.
The size of the patient’s uterus (375 grams) also made it difficult to visualize behind it to place the clamps properly. There was excessive bleeding during the removal because the uterus had to be removed in fragments. This also hindered visibility. It was also noted that Ob-Gyn A could have trapped the patient’s colon close to the operative field while performing lysis of adhesions, allowing a surgical instrument to damage the colon.
Other consultants believed Ob-Gyn A should have used laparoscopic assistance so that the patient’s colon injury could have been recognized and treated. The consultants felt there were many instances where Ob-Gyn A could have recognized the injury. It was also discussed that the patient could have undergone preoperative bowel preparation to prevent stool contamination, since she was at high-risk for a failed vaginal approach and bowel injury.
Disposition
The defense attorneys for Ob-Gyn A and the PA were successful in getting the case dismissed based on a legal technicality. The outcome for the surgery center is not known.
Risk management considerations
There were numerous risk management factors that proved problematic in the defense of this case. According to the consultants, there were significant concerns regarding documentation and informed consent.
Complete and contemporaneous documentation is foundational to the defense of a case. Consultants noted the following documentation concerns regarding the operative note.
- In the operative note, there was no documentation of a visual survey or inspection of the operative field near the completion of the patient’s hysterectomy before the culdoplasty was performed.
- Findings about the lesions, that generally would be in the “finding sections” of the operative report, were not evident.
- The physician assistant was listed as a surgeon.
- No documentation existed about any measures taken to ensure proper outcomes for a patient at high-risk of complications.
- No source or cause for the patient’s blood loss was documented in the operative report.
- No documentation existed of follow up by the surgeon or PA after the procedure was completed.
When dictating an operative note, it is important that the surgeon review the note for any errors or omissions, and to ensure that all clinical care delivered is accurately reflected. Once the note is reviewed for accuracy it should be completed and signed in a timely fashion.
In addition to the documentation concerns, consultants also noted that office visit encounter notes were not completed in a timely fashion. In particular, the encounter note that discussed the risk, benefits, and alternatives of the procedure was not signed until six months after the procedure. This made it unclear if the patient was given time to ask questions and understand the procedure prior to the date of surgery.
Consultants were also critical of the surgery center for failure to confirm that the patient was properly informed of the risks, benefits, and alternatives of the TVH performed. The informed consent form at the surgery center was not signed by the surgeon, further causing concern about whether the patient received a proper informed consent from the surgeon.
Obtaining informed consent is crucial. A patient should be presented with the risks, benefits and alternatives; given an opportunity to ask questions; and given time to consider the information provided in advance of the proposed procedure. Informed consent discussions should be documented in the medical record and contain details of the discussion.
Gracie Awalt can be reached at gracie-awalt@tmlt.org.
Kassie Toerner can be reached at kassie-toerner@tmlt.org.
