Pelvic inflammatory disease: Findings during inpatient treatment of clinically severe, laparoscopy-documented disease Charles H. Livengood III, MD, Gale B. Hill, PhD, and W. Allen Addison, MD Durham, North Carolina OBJECTIVES: We evaluated the relationship between clinically severe pelvic inflammatory disease and laparoscopic diagnosis and grading, comparative treatment with clindamycin plus cefamandole or doxycycline, and a management protocol for inpatient pelvic inflammatory disease treatment. STUDY DESIGN: Thirty-three patients who met our clinical criteria for severe pelvic inflammatory disease underwent diagnostic laparoscopy. Pelvic inflammatory disease patients were randomized to double-blind treatment with clindamycin plus cefamandole or doxycycline within our management protocol; postdischarge oral antibiotics were omitted. RESULTS: Laparoscopy confirmed pelvic inflammatory disease in 23 (70%) patients; 10 (44%) had mild pelvic inflammatory disease by laparoscopic grading. Laparoscopic grade alone predicted necessary duration of therapy to response: mild pelvic inflammatory disease, 2.3 ± 0.5 days; moderate pelvic inflammatory disease, 2.7 ± 1.5 days; and severe pelvic inflammatory disease, 3.9 ± 1.5 days (p < 0.05). Using the management plan presented, response rates for both antibiotic regimens were 100%. CONCLUSIONS: Clinical diagnosis and grading of severe pelvic inflammatory disease has poor specificity. Laparoscopic grading of severity of pelvic inflammatory disease seems accurate. Both clindamycin plus cefamandole and clindamycin plus doxycycline are equally effective regimens for treatment of pelvic inflammatory disease and did not require supplementation after discharge. Our management plan is objective and practical; daily bimanual examination is the most sensitive indicator of persistent disease. (AM J OSSTET GVNECOL 1992;166:519-24.)
Key words: Pelvic inflammatory disease, laparoscopy, clindamycin Laparoscopic examination of patients having pelvic inflammatory disease of unclassified severity by clinical diagnosis has shown the specificity of clinical diagnosis to be :565%.1.2 Clinically severe pelvic inflammatory disease, generally treated with inpatient therapy, is a diagnosis of uncertain specificity. In 1986 Washington et aI.' estimated the direct costs of outpatient and inpatient treatment for pelvic inflammatory disease to be $150 and $2865, respectively, and patients with clinically more severe disease are in greater jeopardy from misdiagnosis. Thus for both economic and medical reasons a better understanding of the accuracy of a clinical diagnosis of severe pelvic inflammatory disease is important. Further, a well-accepted laparoscopic grading system 4 . 5 for pelvic inflammatory disease is in place, but neither the scope of its usefulness in managing clinical disease nor its correlation with clinical findings has been fully explored. Indications for inpatient treatment of pelvic inflammatory disease remain subjective and variable. Current recommendations for hospitalization from the Centers for Disease Control 6 are based on compliance issues and From the Division of Gynecology, Department of Obstetrics and Gynecology, Duke University Medical Center. Supported by grants from The Upjohn Company, Kalamazoo, Michigan; and by grant No. MOJ-RR-30, Division of Research Resources, General Clinical Research Centers Program, National Institutes of Health. Received for publication June 18, 1991; accepted July 15, 1991. Reprint requests: Charles H. Livengood III, MD, Box 3291, Duke University Medical Center, Durham, NC 27710. 611133426
clinical severity of disease, but the latter is undefined. Further, after hospitalization and initiation of a parenteral antibiotic regimen, those circumstances that confirm that adequate therapy has been given and those indicating therapeutic failure with the regimen in use are not well understood. Although many antibiotic regimens have been used with success in the parenteral treatment of pelvic inflammatory disease, optimal therapy can be identified only with continued study of currently available agents. We undertook this study to examine the accuracy of routine clinical diagnosis of pelvic inflammatory disease and our own criteria for severe pelvic inflammatory disease requiring inpatient therapy, to evaluate the clinical usefulness of the accepted laparoscopic grading system and our management plan (outcome classification system) defining therapeutic success and failure, and to study the relative efficacy and safety of clindamycin with either cefamandole or doxycycline in the treatment of clinically severe pelvic inflammatory disease.
Material and methods Women seen in the outpatient and emergency facilities of Duke University Medical Center and assigned a clinical diagnosis of severe pelvic inflammatory disease, for which we uniformly use inpatient therapy, by an attending physician in the Department of Obstetrics and Gynecology were considered for this study. In that one of our goals was to examine the accuracy of ex-
520
Livengood, Hill, and Addison
February 1992 Am J Obstet Gynecol
Table I. Therapeutic outcome classifications for patients hospitalized for pelvic inflammatory disease Response: Requires at least five of the following 1. I. All symptom parameters (see text) = none or mild 2. Cervical motion and adnexal tenderness = none or mild 3. Abdominal tenderness and distention = none or mild 4. Temperature :537.8° C (oral) for ~24 hr 5. White blood cell count between 4000/mm' and 10,000/mm' 10,000 / mm' or >30% decrease if> 1O,000/mm' 1O,000 / mm' on admission 6. 6. Pelvic mass did not develop and if initially present did not increase in size on examination Failure: Progression of disease: After 24 hours of therapy, therapy, worsening of at least four of the parameters above; above; after 48 hours, at least three; onset of septic shock at any time Inadequate improvement: After 96 hours of therapy, failure to improve in at least two of the parameters above Late failure: Response criteria not met by 14 days of therapy or relapse of disease within 10 days of discontinuation of therapy (relapse defined as failure to continue to satisfy criteria for response above) Side effect failure: Onset of any drug-related condition significantly threatening the comfort or health of the patient
pelvic inflammatory disease were required. However, to qualify for severe pelvic inflammatory disease and entry into this study, one or more of the following criteria were required: significant peritonitis defined by low abdominal rebound tenderness extending to the upper abdomen, vomiting, or paralytic ileus by examination; temperature ~39.0° ;:::39.0° C orally; peripheral 3 white blood cell count >20,000Imm' ; >20,000/mm' or
Key words: Pelvic inflammatory disease, laparoscopy, clindamycin Laparoscopic examination of patients having pelvic inflammatory disease of unclassified severity by clinical diagnosis has shown the specificity of clinical diagnosis to be :565%.1.2 Clinically severe pelvic inflammatory disease, generally treated with inpatient therapy, is a diagnosis of uncertain specificity. In 1986 Washington et aI.' estimated the direct costs of outpatient and inpatient treatment for pelvic inflammatory disease to be $150 and $2865, respectively, and patients with clinically more severe disease are in greater jeopardy from misdiagnosis. Thus for both economic and medical reasons a better understanding of the accuracy of a clinical diagnosis of severe pelvic inflammatory disease is important. Further, a well-accepted laparoscopic grading system 4 . 5 for pelvic inflammatory disease is in place, but neither the scope of its usefulness in managing clinical disease nor its correlation with clinical findings has been fully explored. Indications for inpatient treatment of pelvic inflammatory disease remain subjective and variable. Current recommendations for hospitalization from the Centers for Disease Control 6 are based on compliance issues and From the Division of Gynecology, Department of Obstetrics and Gynecology, Duke University Medical Center. Supported by grants from The Upjohn Company, Kalamazoo, Michigan; and by grant No. MOJ-RR-30, Division of Research Resources, General Clinical Research Centers Program, National Institutes of Health. Received for publication June 18, 1991; accepted July 15, 1991. Reprint requests: Charles H. Livengood III, MD, Box 3291, Duke University Medical Center, Durham, NC 27710. 611133426
clinical severity of disease, but the latter is undefined. Further, after hospitalization and initiation of a parenteral antibiotic regimen, those circumstances that confirm that adequate therapy has been given and those indicating therapeutic failure with the regimen in use are not well understood. Although many antibiotic regimens have been used with success in the parenteral treatment of pelvic inflammatory disease, optimal therapy can be identified only with continued study of currently available agents. We undertook this study to examine the accuracy of routine clinical diagnosis of pelvic inflammatory disease and our own criteria for severe pelvic inflammatory disease requiring inpatient therapy, to evaluate the clinical usefulness of the accepted laparoscopic grading system and our management plan (outcome classification system) defining therapeutic success and failure, and to study the relative efficacy and safety of clindamycin with either cefamandole or doxycycline in the treatment of clinically severe pelvic inflammatory disease.
Material and methods Women seen in the outpatient and emergency facilities of Duke University Medical Center and assigned a clinical diagnosis of severe pelvic inflammatory disease, for which we uniformly use inpatient therapy, by an attending physician in the Department of Obstetrics and Gynecology were considered for this study. In that one of our goals was to examine the accuracy of ex-
520
Livengood, Hill, and Addison
February 1992 Am J Obstet Gynecol
Table I. Therapeutic outcome classifications for patients hospitalized for pelvic inflammatory disease Response: Requires at least five of the following 1. I. All symptom parameters (see text) = none or mild 2. Cervical motion and adnexal tenderness = none or mild 3. Abdominal tenderness and distention = none or mild 4. Temperature :537.8° C (oral) for ~24 hr 5. White blood cell count between 4000/mm' and 10,000/mm' 10,000 / mm' or >30% decrease if> 1O,000/mm' 1O,000 / mm' on admission 6. 6. Pelvic mass did not develop and if initially present did not increase in size on examination Failure: Progression of disease: After 24 hours of therapy, therapy, worsening of at least four of the parameters above; above; after 48 hours, at least three; onset of septic shock at any time Inadequate improvement: After 96 hours of therapy, failure to improve in at least two of the parameters above Late failure: Response criteria not met by 14 days of therapy or relapse of disease within 10 days of discontinuation of therapy (relapse defined as failure to continue to satisfy criteria for response above) Side effect failure: Onset of any drug-related condition significantly threatening the comfort or health of the patient
pelvic inflammatory disease were required. However, to qualify for severe pelvic inflammatory disease and entry into this study, one or more of the following criteria were required: significant peritonitis defined by low abdominal rebound tenderness extending to the upper abdomen, vomiting, or paralytic ileus by examination; temperature ~39.0° ;:::39.0° C orally; peripheral 3 white blood cell count >20,000Imm' ; >20,000/mm' or
