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A Randomized Comparison of Total or Supracervical Hysterectomy: Surgical Complications and Clinical Outcomes

From the Departments of Obstetrics, Gynecology and Reproductive Sciences, Epidemiology and Biostatistics, and Institute for Health Policy Studies, University of California, San Francisco, San Francisco, California; University of Tennessee, Memphis, Tennessee; Wayne State University, Detroit, Michigan; University of California, San Diego, La Jolla, California; University of Alabama, Birmingham, Alabama

Address reprint requests to: Lee A. Learman, MD, PhD, Department of Obstetrics and Gynecology — Room 6D-9, San Francisco General Hospital, 1001 Potrero Street, San Francisco, CA 94110; E-mail: learmanl{at}obgyn.ucsf.edu.

	ABSTRACT

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
OBJECTIVE: To compare surgical complications and clinical outcomes after total versus supracervical abdominal hysterectomy for control of abnormal uterine bleeding, symptomatic uterine leiomyomata, or both.

METHODS: We conducted a randomized intervention trial in four US clinical centers among 135 patients who had abdominal hysterectomy for symptomatic uterine leiomyomata, abnormal uterine bleeding refractory to hormonal treatment, or both. Patients were randomly assigned to receive a total or supracervical hysterectomy performed using the surgeon’s customary technique. Using an intention-to-treat approach, we compared surgical complications and clinical outcomes for 2 years after randomization.

RESULTS: Sixty-eight participants were assigned to supracervical hysterectomy (SCH) and 67 to total abdominal hysterectomy (TAH). Hysterectomy by either technique led to statistically significant reductions in most symptoms, including pelvic pain or pressure, back pain, urinary incontinence, and voiding dysfunction. Patients randomly assigned to (SCH) tended to have more hospital readmissions than those randomized to TAH, but this difference was not statistically significant. There were no statistically significant differences in the rate of complications, degree of symptom improvement, or activity limitation. Participants weighing more than 100 kg at study entry were twice as likely to be readmitted to the hospital during the 2-year follow-up period (relative risk [RR] 2.18, 95% confidence interval [CI] 1.06, 4.48, P = .034).

CONCLUSION: We found no statistically significant differences between (SCH) and TAH in surgical complications and clinical outcomes during 2 years of follow-up.

Hysterectomy remains the most common major operation performed on nonpregnant women in the United States, with over a half million procedures each year.¹ Before cervical cytology screening was introduced as an effective method for preventing cervical cancer, gynecologists routinely removed the nondiseased cervix at the time of hysterectomy to prevent cancer of the cervical stump.² Consequently, total hysterectomy (removal of both the corpus uteri and cervix uteri) was the usual procedure, and subtotal or (SCH) was reserved for rare clinical circumstances in which cervical removal presented undue risks to the patient.

Uncontrolled studies have associated total hysterectomy with difficulties in sexual functioning, pelvic support, and urinary problems.^3–6 Concerns over these outcomes have fueled an increase in patient and clinician interest in (SCH) during the past decade. Between 1988 and 1998, the rate of total abdominal hysterectomy (TAH) in Denmark decreased by 38% and the rate of (SCH) increased by 458%.⁷ In the United States the rates of TAH and (SCH) in New York State showed a similar pattern,⁸ although TAH is still considerably more common.

Proponents of (SCH) argue that creating the cervicovaginal plane may damage nerve structures important to bladder and sexual function, that removing the cervix may increase operative time and blood loss, and that exposure to vaginal flora during the final stages of TAH could increase the risk of infection.⁹ Retrospective studies of variable quality have associated (SCH) with lower risks of wound infection and ureteral injury, less alteration in sexual functioning, and lower rates of urinary incontinence.^10–13

To provide additional evidence to inform patient and clinician decision-making, we report clinical outcomes from the Total or Supracervical Hysterectomy (TOSH) study. TOSH is a multicenter, randomized trial conducted in four US cities in which the effectiveness of TAH and (SCH) were compared in women who had abdominal hysterectomy for symptomatic uterine leiomyomata, abnormal uterine bleeding, or both. The current report focuses on perioperative morbidity, including infectious morbidity and urinary tract injury, and clinical outcomes during 2 years of follow-up.

	MATERIALS AND METHODS

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
To confirm that no randomized trials had been conducted in the United States, we searched MEDLINE for systematic reviews of total versus supracervical hysterectomy using a comprehensive search string¹⁴ and searched for additional trials using the search string "hysterectomy AND randomized AND (subtotal or supracervical or supravaginal)." No trials done in the United States were identified.

The TOSH study recruited women from the following two principal groups: (1) premenopausal women over 30 years who have symptomatic uterine leiomyomata (bleeding, pressure, or pain) and have decided with their gynecologist to undergo abdominal hysterectomy; and (2) premenopausal women over 30 years who have abnormal uterine bleeding, have a documented minimum 3-month trial of hormonal management, and have decided with their gynecologist to undergo abdominal hysterectomy. Patients entering the TOSH study with presumed uterine fibroids needed to have the diagnosis confirmed by ultrasound, hysteroscopy, or other diagnostic study. Patients entering TOSH with abnormal uterine bleeding were required to have a structural evaluation of the endometrial cavity within 6 months before randomization (by ultrasound, hysteroscopy, or hysterogram) to exclude lesions amenable to hysteroscopic treatment.

Women over 45 years were included if (1) their follicle stimulating hormone level was less than or equal to 30 mIU/mL and (2) an endometrial biopsy within 6 months was negative for hyperplasia or carcinoma. All potential participants were required to have a Papanicolaou smear within 1 year before randomization showing no cellular changes suggestive of dysplasia. Exclusion criteria for TOSH were (1) age greater than 50 years at screening, (2) positive results of pregnancy test, (3) desire for future childbearing, (4) known or suspected genital tract carcinoma, (5) cervical dysplasia or carcinoma-in-situ, (6) complex or atypical endometrial hyperplasia, (7) candidate for vaginal hysterectomy (as determined by their gynecologist), and (8) unlikely to remain geographically accessible for 4 years.

Participants were recruited from the gynecology clinics at the University of Alabama, Birmingham; University of Tennessee, Memphis; Wayne State University, Detroit; and clinics affiliated with the University of California, San Diego. These women were identified primarily through screening efforts that were designed to identify women with abnormal uterine bleeding, with or without uterine leiomyomata. Women with abnormal uterine bleeding were recruited if they were willing to be randomly assigned either to medicine versus hysterectomy if dissatisfied after receiving a trial of cylic medroxyprogesterone acetate therapy. Women already planning hysterectomy were recruited if they were willing to be randomly assigned to total versus (SCH). Between January 1998 and April 2000 we screened 729 women and identified 163 who were eligible for the TOSH trial (Figure 1). Of these, 135 (83%) were willing to be randomly assigned to supracervical hysterectomy or TAH. Follow-up data were available at 24 months for 64 of 67 subjects (96%) assigned to TAH and for 61 of 68 subjects (90%) assigned to (SCH). The difference in loss-to-follow-up was not statistically significant (P = .20).

View larger version (18K): [in this window] [in a new window]   Figure 1. Study enrollment and follow-up. TOSH = Total or Supracervical Hysterectomy; SCH = supracervical hysterectomy; TAH = total abdominal hysterectomy. Learman. Total or Supracervical Hysterectomy RCT. Obstet Gynecol 2003.

The TOSH study was designed to closely reflect what occurs in community practice, as is typical in effectiveness trials. We allowed surgeons to perform total or supracervical hysterectomies using their customary techniques. We indicated that bilateral oophorectomy should be performed only to treat abnormal findings or at the patient’s specific request and not electively according to the surgeon’s practice style. We did not establish consensus guidelines for antibiotic prophylaxis; type of anesthesia used; removal or ablation of endocervical tissue in the supracervical hysterectomy group; criteria for concomitant nonadnexal procedures, including bladder neck suspension, wound closure techniques, and postoperative management of bowel or bladder function; evaluation and treatment of febrile episodes; or criteria for hospital discharge.

At the randomization visit and every 3 months for 2 years, participants answered an elaborate battery of questionnaires with checklists and Likert scales assessing demographics; gynecologic and reproductive history (at baseline only); and symptomatology, including magnitude and effects of bleeding, pelvic pain, pelvic or bladder pressure, low back pain, and urinary incontinence; and quality of life measures including sexual functioning. Local research assistants extracted data on hysterectomy characteristics and inpatient complications from operative reports, pathology reports, and discharge summaries by using checklists designed for this purpose. Length of hospitalization was calculated as date of discharge minus date of admission (usually the day of surgery). When hemorrhage was listed as a complication or blood transfusions were given, we logged these events and recorded the details. We did not classify excessive blood loss estimates or hemoglobin changes as a hemorrhage.

Febrile morbidity was recorded as a complication when it was listed in the discharge summary and was further classified by review of each discharge summary. Fevers attributed to atelectasis or for which no antibiotic treatment was given (eg, early, transient temperature elevations) were classified as "fever of noninfectious cause," fevers treated with antibiotics but without a specific source identified were classified as "fever of unknown source, treated," and fevers attributed to a specific source of infection were listed as such. Other perioperative complications were recorded when they were listed in the operative report or discharge summary and were not classified further.

Hospitalizations were ascertained comprehensively from cross-referencing abstracted data from the hysterectomy admission, institutional data with diagnosed related group codes on readmissions to hospitals affiliated with each clinical center, and patients’ reports of hospitalization assessed every 3 months during the study. Hysterectomy hospitalizations were excluded, and the remaining hospitalizations were grouped by time from randomization and by indication for admission. Gastrointestinal problems included admissions for abdominal pain, postoperative ileus, small bowel obstruction, lysis of adhesions, nausea or vomiting, pancreatitis, gastrointestinal bleeding, and cholecystectomy. Wound complications included admissions for wound disruption, cellulitis, and ventral or incisional hernia. Cardiovascular or pulmonary problems included admissions for chest pain, suspicion of myocardial infarction, stroke, pulmonary embolism, pneumonia, and hypertension. Other problems included admissions for cancer, infections, depression, sinusitis, and metabolic problems. Admissions were classified independently into one of the categories by one of the authors, and as "attributed, at least in part, to hysterectomy" in an independent review by three authors who were blinded to treatment group assignment; discrepancies were resolved by discussion and consensus.

All statistical analyses were conducted using an intention-to-treat approach. We analyzed differences in categorical variables by using ² or Fisher exact test and differences in continuous variables by using t tests or linear regression models. Risk ratios [RRs] and confidence intervals [CIs] summarizing treatment effects on dichotomous outcomes were estimated using Mantel-Haenszel techniques. Generalized estimating equation logistic models were used to assess differential improvement over time in repeated dichotomous measures. We used Cox models with a frailty to assess treatment differences in the rates of all readmissions and conventional Cox models to assess other predictors of first readmission, after adjusting for treatment group and socioeconomic status. A two-tailed P < .05 was considered statistically significant.

The TOSH study was designed to detect meaningful changes in quality of life outcomes, which are not the focus of this report, and the recruitment goals were exceeded. The final sample size of 135 randomized participants provided 80% power at = 0.05 to detect 2.5-to 3.4-fold treatment-related increases in readmission, depending on the baseline readmission risk.

A data and safety monitoring board monitored the study every 6–12 months for adverse trends in either treatment group. At each meeting, the board deemed the adverse study outcomes to be consistent with those published for hysterectomies in general and allowed the study to continue without modification.

	RESULTS

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
Between January 1998 and June 2000, we enrolled 135 women, 54 from Birmingham, 51 from Memphis, 20 from Detroit, and 10 from San Diego. Sixty-seven were assigned to undergo TAH and 68 to undergo (SCH). Baseline comparisons between the (SCH) and TAH groups are given in Table 1. There were no statistically significant differences between the treatment groups at baseline in demographic variables, bleeding pattern, and preoperative diagnoses.

Surgical characteristics, operative findings, and complications are listed in Table 2. There were no statistically significant differences between treatment groups in antibiotic prophylaxis, ovarian removal, weight of the uterine specimen, or histopathologic diagnoses. Two (SCH) patients had complex hyperplasia of the endometrium without atypia. One TAH patient had a high-grade sarcoma in her hysterectomy specimen. The preoperative evaluation for this 47-year-old patient with menorrhagia included a physical examination showing a 16-week-size fibroid uterus 1 month before hysterectomy and a normal Papanicolaou smear and endometrial biopsy (proliferative) 9 months before hysterectomy. The pathologic diagnoses from the hysterectomy specimen included multiple uterine leiomyomata up to 3 cm in maximal diameter and a secretory endometrium. A high-grade endometrial stromal sarcoma with leiomyosarcomatous differentiation was found adjacent to a submucous leiomyoma and an implant of adenomyosis. In addition, three TAH patients had high-grade squamous intraepithelial lesions of the cervix. Two of these patients had moderate dysplasia (cervical intraepithelial neoplasia [CIN] II), one with normal results of a prior Papanicolaou test and one with a prior Papanicolaou test result of atypical squamous cells of unknown significance. The other patient had moderate to severe dysplasia (CIN II–III) after a normal prior Papanicolaou test. There were no statistically significant differences in procedure time, estimated blood loss, febrile events, length of stay, and surgical complications. Hemorrhage, blood transfusion, and urinary tract injuries were uncommon in both groups.

Pelvic symptoms and back pain were reduced by 48–97% from their baseline levels at 24 months after either operation, but there were no statistically significant differences in the degree of reduction between the (SCH) and TAH groups (Table 4). We found no statistically significant treatment effects in menopausal symptoms between the (SCH) and TAH groups. Urinary symptomatology and incontinence were reduced by 41–88% from baseline levels at 24 months in both groups, with no differential improvement according to randomized treatment.

Finally, we explored the effect of clinical center variation on the results of our trial. In a sensitivity analysis comparing multivariable models with and without adjustment for clinical center, the P values for treatment, time, and the time-by-treatment interaction were essentially unaffected.

	DISCUSSION

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
The decision to retain or remove the cervix at hysterectomy should be based on evidence that can inform patients and their gynecologists about the differences, if any, between the two approaches. The potential benefits and risks of cervical retention should be evaluated rigorously before they are used to promote or discredit (SCH). The TOSH trial is the first US trial to compare outcomes after (SCH) and TAH. This report focuses on surgical complications and clinical outcomes, including infectious morbidity, hemorrhagic complications, and urinary tract injury, all of which were hypothesized to be higher with TAH than with (SCH). Instead, we found no statistically significant differences in the rate of complications or degree of symptom improvement and a tendency toward more hospital readmissions in the (SCH) group.

Hysterectomy by either technique led to substantial reductions in most symptoms, including pelvic pain or pressure, back pain, urinary incontinence, and voiding dysfunction. In a recent randomized clinical trial of TAH and (SCH) in a sample of predominantly white women from two London hospitals, Thakar et al¹⁵ found neither technique to adversely affect pelvic organ function at 12 months of follow-up. (SCH) patients had fewer postoperative complications but more postdischarge complications than TAH patients during the hysterectomy admission. Several differences in the inclusion criteria of the two trials are noteworthy. The trial by Thakar et al excluded women with comorbidities that would increase the likelihood of adverse surgical outcomes, including a body weight exceeding 100 kg, previous pelvic surgery, and known endometriosis. Our trial made no such exclusions.

Using ascertainment techniques similar to those used in our study (I. Manyonda, personal communication November 25, 2002), Thakar et al¹⁵ reported that 1.8% of their subjects were readmitted within 1 year after surgery for a reason directly related to the operation. Our higher rate of hysterectomy-related readmission in the first year (6.7%) is explained in part by our inclusion of women weighing over 100 kg, which was associated with readmission after hysterectomy. A prospective cohort study of 1299 Maryland women found that the best predictor of patient dissatisfaction was not the occurrence of inpatient complications, but rather readmission for a postdischarge complication. The readmission rate in the Maryland study, based on self-report data, was 5.4% during the 24 months after hysterectomy, which is similar to the rate in our trial.¹⁶

The TOSH trial was designed to maximize its external validity. We recruited women from a racial and ethnic group at disproportionate epidemiologic risk of hysterectomy (African-American women¹⁷) and women who had a disease that accounts for more hysterectomies performed in the United States than any other uterine condition (symptomatic uterine leiomyomata).¹⁸ Our participants were from diverse geographic regions, socioeconomic backgrounds, and health care delivery systems. Although the essential steps of hysterectomy are the same in each case, clinician preferences exist in the use of specific techniques, instruments, and suture materials. Findings from a trial in which these specific techniques were controlled would represent less well the diversity with which gynecologists perform the procedure. The price paid in using an effectiveness approach, however, is a risk of greater variability in the use of co-interventions. For example, three quarters of the hysterectomies in each group were accompanied by antibiotic prophylaxis, but our methodology did allow for within-and between-group differences in choice of antibiotic regimens.

Most clinical outcomes relied on documentation of events instead of direct measurement by the investigators. We aimed to detect urinary tract injuries presenting as obvious intraoperative or postoperative clinical complications. We did not require any systematic tests of urinary tract patency, as these are not generally obtained in the communities in which the procedures were performed. We therefore cannot exclude the possibility that clinically occult injuries went undetected. The estimated blood loss was derived from the surgeon’s estimate. We did not compare a change in hematocrit or hemoglobin. We believe that clinically significant surgical bleeding was adequately assessed by our study outcomes (ie, intraoperative hemorrhage and blood transfusion).

Another limitation of our study was the lack of blinding. Participants were informed which procedure they received, in part to be sure that women with an intact cervix knew that they would need to continue cervical cancer screening. The clinicians providing postoperative care were not blinded to the type of hysterectomy that patients received. Physicians with a strong bias for or against cervical removal were unlikely to participate in the trial. However, we cannot exclude the possibility that more subtle biases may have influenced their approach to evaluating and treating febrile events and their inclusion of these events in discharge abstracts and summaries. Importantly, coordinating center physicians blinded to random assignment classified disease events and readmissions.

Although our trial was large enough to detect moderate magnitude differences in common outcomes, we had limited power to detect smaller differences. To do that would require a far larger study. For example, more than 2000 subjects would need to be randomized to provide adequate power (80%) at = 0.05 to detect a 2% versus 4% difference in the rate of urinary tract injury.

Several intriguing findings underscore the need for further investigation. Our protocol included structural evaluation of the endometrial cavity for all patients with abnormal bleeding and endometrial biopsy for all women 45 years or older. Nevertheless, surgical specimens included a surprising number of undiagnosed endometrial polyps, cases of endometrial hyperplasia, and one case of uterine sarcoma. Despite the requirement of up-to-date cervical cancer screening and the exclusion of patients with a history of cervical dysplasia, three TAH patients had high-grade dysplasia in their cervical specimens. This finding may reflect limitations in the sensitivity of cervical cancer screening tests.¹⁹

Persistent vaginal bleeding led to trachelectomy in one (SCH) patient 15 months after hysterectomy. Our protocol for the (SCH) group did not include routine resection or ablation of endocervical tissue to prevent such a complication. A post-hoc review of 50 operative reports (79% of the 63 (SCH) participants) revealed that only half (25) of these operations included excision or destruction of upper cervical or endocervical tissue. Nevertheless, our rate of post-(SCH) cyclic vaginal bleeding (three of 60 at 24 months, or 5.0%) is similar to the rate (6.8%) in the randomized trial by Thakar et al,¹⁵ in which the endocervical canal was routinely electrocoagulated.

We expected more voiding dysfunction and incontinence in the TAH group, on the basis of anatomic considerations and prior published reports, but both groups had substantial improvements in urinary symptoms. These findings are consistent with those of the randomized trial of Thakar and colleagues,¹⁵ which showed marked improvement in urinary symptoms and urodynamic indices after both TAH and (SCH). A meta-analysis based on primary articles of limited quality showed that prior hysterectomy increased the risk of incontinence from 30–41% only in subgroups of women over 60 years at first assessment.¹² Extrapolating from the typical age at hysterectomy, incontinence risk increased after at least a decade had passed since the procedure. A recent review underscored the discrepancy between cross-sectional studies showing a negative influence of prior hysterectomy on urinary incontinence, and prospective, controlled studies showing the opposite.²⁰ A clear understanding of the effect of cervical removal on later pelvic floor dysfunction will be possible only after large studies are conducted with adequate controls and long-term follow-up.

In this report of outcomes from the TOSH trial, our data suggest that surgical complications and clinical outcomes after supracervical hysterectomy and TAH are similar during 2 years of follow-up. There was a trend toward more readmissions after supracervical hysterectomy, which was not statistically significant. Our findings increase the importance of determining whether the cervix plays an important role in sexual functioning and satisfaction. Subsequent analyses from the TOSH trial will focus on these and other quality of life outcomes.

	APPENDIX

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION APPENDIX REFERENCES

 
The TOSH Research Group
Clinical Centers
University of Alabama, Birmingham: R.E. Varner, MD (principal investigator), H. Richter, MD, PhD (co-investigator), Robert L. Holley, MD (co-investigator), Seine Chiang, MD (co-investigator), V. Bannister, RN (clinic coordinator), L. Abdo, RN, CCRC (clinic coordinator), Alison Myrich (research technician)

University of California, San Diego: E. Barrett-Connor, MD (principal investigator), D. Goodman-Gruen, MD, PhD (co-investigator), A. Fleming, RN (clinic coordinator)

University of Tennessee, Memphis: R.L. Summitt, Jr, MD (principal investigator), F.W. Ling, MD (co-investigator), Gary H. Lipscomb, MD (co-investigator), Marie Woodruff, RN, CCRC (clinic coordinator), D. Bran, RN, CCRC (clinic coordinator), M.F. Braslow (senior research technician).

Wayne State University, Detroit: S.G. McNeeley, MD (principal investigator), S. Hendrix, DO (co-investigator), D. Kmak, MD (co-investigator), Paul R. Makela, MD (co-investigator), J. Mowery, RN (clinic coordinator), M. McNamee, RN (research nurse).

Coordinating Center
University of California, San Francisco; E. Washington, MD, MSc (study chair), S.B. Hulley, MD, MPH (principal investigator), L. Learman, MD, PhD (co-investigator, gynecology), M. Kuppermann, PhD (co-investigator, quality of life), J. Showstack, PhD (co-investigator, health economics), E. Vittinghoff, PhD (statistician), F. Lin, MS (statistical programmer), C. Ireland, MPH (project director), C. Gehrman (programmer).

Sponsor
Agency for Health Care Research and Quality: H. Hubbard, RN, MPH (project officer).

Data and Safety Monitoring Board: C. Westhoff, MD, MSc (chair), J. Wittes, PhD, M. Hlatky, MD (2000–2003), W. Applegate, MD (1997–2000).

"For additional information on the TOSH study, access the monograph on baseline characteristics at http://coordinatingcenter.ucsf.edu/ms."

	Footnotes

 
This project was supported by grant number UO1 HS09478 from the Agency for Health Care Research and Quality.

^* See Appendix for a list of all participants.

doi:10.1016/S0029-7844(03)00664-1

Received March 13, 2003. Received in revised form May 20, 2003. Accepted June 5, 2003.

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7. Gimbel H, Settnes A, Tabor A. Hysterectomy on benign indication in Denmark 1988–1998. A register based trend analysis. Acta Obstet Gynecol Scand 2001;80:267–72.[Medline]

8. Sills ES, Saini J, Applegate MS, McGee M, Gretz HF. Supracervical and total hysterectomy trends in New York State: 1990–1996. J Urban Health Bull NY Acad Med 1998;75:903–10.[Medline]

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