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ORIGINAL RESEARCH |
From the *Department of Obstetrics and Gynecology, Campus Luebeck, University of Schleswig-Holstein, Kiel; and Department of Gynecology, Friedrich-Schiller-University, Jena, Germany.
Address reprint requests to: Chr. Altgassen, MD, Department of Obstetrics and Gynecology, University Hospital of Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany; e-mail: altgassen{at}frauenklinik.uni-luebeck.de.
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ABSTRACT |
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METHODS: The length of the learning curve, duration of surgery, change of hemoglobin (in grams per liter), conversion rate, and intra- and postoperative complications were evaluated. Cases were analyzed according to the order for the individual surgeon.
RESULTS: Thirty-three surgeons performed 929 laparoscopic-assisted vaginal hysterectomies during the study period. Analyzing the duration of surgery and rate of complications, we decided on a cutoff of 30 cases. Eight surgeons with more than 30 cases performed 668 laparoscopic-assisted vaginal hysterectomies. Their initial 30 cases (group A, the first 30 cases) were compared with their subsequent cases (group B, cases 31 and after). Patient age, body mass index, and uterine weight did not differ between the groups. The intraoperative complication rate dropped from 4.2% to 0.5% (P = .001), hemoglobin drop decreased from –0.8 ± 0.9 g/L to –0.5 ± 1.0 g/L (P = .002), and postoperative complications dropped from 12.9% to 7.0% (P = .017). The duration of surgery was also shorter (148.8 ± 45.4 minutes versus 125.1 ± 46.5 minutes), but this difference was taken from the results of 1 surgeon.
CONCLUSION: A learning experience of 30 laparoscopic-assisted vaginal hysterectomies was necessary in our institution to reach a low level of complications. Duration of the surgical procedure was not an adequate study endpoint to assess a learning effect.
LEVEL OF EVIDENCE: II-3
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METHODS |
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All women underwent preoperative pelvic ultrasonography routinely and, if indicated, endometrial sampling. Laparoscopic-assisted vaginal hysterectomy was performed in patients under general anesthesia in a standardized fashion by all surgeons.7 Patients kept an indwelling catheter until the first postoperative morning. After surgery low molecular heparin was administered daily in all patients for the prevention of thromboembolism. All procedures were video documented.
The duration of surgery was calculated from the insertion of the Veress needle until skin closure of the trocar sites. The weight of the uterus was measured by a digital scale immediately after surgery. The patients’ hemoglobin levels were checked preoperatively and on the second day after surgery. All patients were evaluated clinically and by ultrasonography on the day of discharge.
Complications were defined as either intraoperative or postoperative complications. Intraoperative complications included bleeding requiring transfusion; bladder, bowel, and ureteral injury; subcutaneous emphysema; and unintended conversion from laparoscopic-assisted vaginal hysterectomy to abdominal hysterectomy. Postoperative complications were classified as 1) major: hemorrhage requiring treatment, fistula formation, thrombosis, embolism, or reoperation within 8 weeks or 2) minor: fever, including unexplained, related to operative site, or not related to operative site (eg, urinary tract infection); infiltration of the vaginal vault (clinically palpable and painful mass or sonogenic mass more than 4 cm without complaints); wound complications; and others. When there was more than 1 postoperative complication (2 cases), the causative problem was taken into account; for example, vault infiltration and associated fever was considered as vault infiltration.
Surgeries of all laparoscopic-assisted vaginal surgeons in our institution were analyzed. Procedures were subgrouped according to the individual order of each surgeon: I, 1st to 10th case of each surgeon; II, 11th to 20th case of each surgeon; III, 21st to 30th case of each surgeon; IV, 31st to 40th case of each surgeon; V, 41st to 50th case of each surgeon; VI, 51st to 75th case of each surgeon; VII, 76th to 100th case of each surgeon; and VIII, more than 100th case of each surgeon. For analysis, subgroups were defined as group A (less than a cutoff to be chosen) and group B (more than a cutoff to be chosen). Group O comprised all cases of surgeons who did not operate more than the cutoff to be chosen.
Data were collected in an Access data base (Microsoft, Redmond, WA), and statistics were analyzed with SPSS (SPSS, Chicago, IL). The Fisher exact test was used for comparison of complications, patients’ history, and indication. Duration of surgery and hemoglobin difference was evaluated with Student t test. Mann–Whitney U test was used to compare age, body mass index (BMI), and uterine weight. Data underwent a Bonferroni correction. A P value of .05 was considered to be of statistical significance.
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RESULTS |
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The overall (group A and group B) median age of patients was 47 years (interquartile range 11 years; range 27–91 years) and overall (group A and group B) BMI was 25.7 kg/m2 (interquartile range 6.3 kg/m2; range 16.4–55.7 kg/m2). The overall (group A and group B) median uterine weight was 218 g (interquartile range 152 g; range, 38–2,800 g). Age, BMI, and uterine weight did not differ significantly between group A and group B (Table 2).
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Additional adnexal surgery and history of open lower abdominal surgery were more common in group A than in group B, whereas no difference was found with regard to nulliparity, number of cesarean deliveries, or previous lower abdominal surgery (Table 3). The indications for surgery are in Table 4, and the most common was fibroids with or without symptoms.
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Overall (group A and group B) time of surgery was 133.5 ± 47.5 minutes (range, 42–342 minutes). Although operation time decreased significantly (Table 2; P < .001), this was only because of surgeon number 3. All others failed to show a significant improvement of operation time.
Intraoperative complication rate, hemoglobin difference, and postoperative complications were better in group B (Table 2). Intraoperative complications were more common in group 4 (Tables 2 and 5). All bowel injuries were serosal lesions. During the vaginal part of the procedure, 4 bladder injuries occurred, and 1 occurred during the laparoscopic dissection of the vesicouterine septum in group A. No ureteral injury occurred. Conversion to abdominal hysterectomy was the result of bleeding in the area of the ovaries, which could not be controlled without removing the ovary (uterine weight 780 g) and difficulty transecting the uterine arteries laparoscopically (uterine weight 480 g).
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Two fistulae occurred as major postoperative complications. One occurred within a surgeon's first 10 procedures (1st to 10th) in an elderly woman who also had a bilateral salpingo-oophorectomy and ureterolysis. She developed an ureterovaginal fistula on the 10th day after surgery because of cauterization close to the ureter. After the insertion of a ureteral stent, the fistula closed spontaneously. The second occurred in a surgeon's 76th- to 100th- procedure range. A middle-aged woman developed a vesicovaginal fistula on day 21 after surgery that closed spontaneously after insertion of a suprapubic catheter.
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DISCUSSION |
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Teaching a surgical procedure should not compromise safety. Any discussion of a learning curve should first identify factors that constitute measurable endpoints that signify some form of improvement.8 The reduction of operating time and complications are the factors mostly quoted in the literature.9–18,20 In several studies operation time of laparoscopic-assisted hysterectomy as a new procedure dropped gradually.8–10 Rosen et al8 concluded from their prospective study in total laparoscopic and laparoscopic-assisted vaginal hysterectomy in 54 cases that the process of learning is completed after 10 cases for the experienced surgeon, whereas a trainee could get permission for unsupervised surgery after 16 cases. Performing 86 cases, Shwayder et al11 separated cases in 4 groups and found a reduction of surgery time after 20 cases.
The existence of a learning curve was questioned by Ou et al12 in an analysis of 839 laparoscopic-assisted vaginal hysterectomies by 4 surgeons. The authors could not find a reduction of operation time. They concluded that as experience accrues, the surgeon might begin to accept more difficult cases. The difficulties of procedures undertaken, therefore, represent a potentially confounding variable that may mask a relationship between experience and efficiency. This point of view is supported by Councell et al,13 who analyzed 178 laparoscopic-assisted hysterectomies by 3 surgeons that showed a trend toward a diminished duration and an increasing uterine volume but failed to demonstrate a significant difference.
Our study questions the existence of a learning curve on the basis of operating time. Although operation time was reduced from 148.8 minutes to 125.1 minutes in our study, there was no difference for 7 of 8 surgeons, and we failed to identify a cutoff with regard to duration of surgery. Because indication for surgery, uterine weight, parity, and number of previous cesarean deliveries did not differ, more complex surgical procedures could not have been an appropriate explanation. We assume that the mode of step-by-step teaching (from second assistance to first assistance and the surgical procedure itself) equalizes any possible gain of time. Therefore, operation time for the teaching surgeon might not be as fast as it could be and operation time for the trainee might not be as long as it might be without proper training. We conclude that duration of surgery may not be appropriate to assess a learning effect in a teaching institution.
Visco et al14 found a drop of conversion to abdominal hysterectomy from 34.9% to 12.4% after 5 cases in a North Carolina query. The overall conversion rate in 3,728 laparoscopic-assisted vaginal hysterectomies performed by 602 attending physicians was 21.5%, and 2,998 (80%) cases represented the first 20 laparoscopic-assisted vaginal hysterectomies for the individual surgeon.14 Among the first 100 patients, the conversion rate was 19% compared with the last 100 patients, where the conversion rate dropped to 5% (P = .002). These findings were supported by Jones,15 who compared the first 250 laparoscopic hysterectomies with the second 250 laparoscopic hysterectomies performed by a single surgeon. Rate of conversion dropped with the passage of time and increasing experience. This was despite more difficult procedures being undertaken and the inclusion of additional procedures. They concluded that the decrease of conversion rate seems to be associated with longer experience of performance. The only 2 conversions in our series occurred in group A (0.8%), supporting these findings. We believe that conversion is not necessarily a sign of complication when a new technique is acquired; it also could be a sign of wisdom and patient care if circumstances appear to become too difficult.
Rosen et al8 reported that setting blood loss was higher when surgery was performed by a trainee compared with by an experienced surgeon. This is in contrast to the Adelaide audit, which analyzed 1,904 patients in 19 hospitals between 1991 and 1998. Estimated blood loss remained fairly constant and dropped from 274 mL to 213 mL whereas the rate of hemorrhage increased from 3.5% to 4.7%.16 This difference could be explained by the circumstances: the Adelaide audit was undertaken when the technique was fairly new and spread rapidly. In our study, we found a significant reduction of hemoglobin drop after 30 cases as a sign of the learning effect. No blood transfusions were necessary.
Jones15 compared the first 250 laparoscopic hysterectomies with the second 250 laparoscopic hysterectomies performed by a single surgeon. In this study, a clear reduction of complications occurred after 200 cases. This high number might be explained by the fact that more complex procedures were undertaken. In large series of 1,647 total laparoscopic hysterectomies comparing 695 women undergoing total laparoscopic hysterectomy between 1989 and 1995 with 952 women undergoing surgery between 1996 and 1999 by Wattiez et al17 revealed a significant reduction of major complications (urinary tract injuries, bladder laceration, conversion to laparotomy, need for blood transfusion, and number of reoperation) from 5.7% to 1.3%. Both studies do not offer a realistic cutoff. In our study the intraoperative complication rate dropped significantly from 4.2% to 0.5% as a sign of a learning effect after 30 procedures.
The comparison of the first 200 and the second 300 laparoscopic hysterectomies by a single surgeon showed a decrease of postoperative complications from 9.5% to 4.3%.15 The rate of postoperative complication in our study dropped from 12.9% to 7.0% (P = .017). The difference is the result of the lower rate of urinary tract infections in group B, although intra- and perioperative management did not change throughout the study period.
Interestingly, we found that the rate of intra- and postoperative complications in our surgeons who performed fewer than 31 cases were lower than in group A. We believe this is an example of the argumentation cited above that more complex surgical procedures are for the more experienced surgeon (staff) because the rate of hysterectomy without additional surgery was lower than in group A.
The major limitation of our study is that it is retrospective in nature. However, given this, we were able to evaluate both factors important to assess and identify a cutoff for competence.
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Footnotes |
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10.1097/01.AOG.0000132806.46344.05
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REFERENCES |
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2. Summitt RL, Stovall TG, Steege JF, Lipscomb GH. A multicenter randomized comparison of laparoscopically assisted vaginal hysterectomy and abdominal hysterectomy in abdominal hysterectomy candidates. Obstet Gynecol 1998;92:321–6.[Abstract]
3. Phipps JH, John M, Nayak S. Comparison of laparoscopically assisted vaginal hysterectomy and bilateral salpingo-oophorectomy with conventional abdominal hysterectomy and bilateral salpingo-oophorectomy. Br J Obstet Gynaecol 1993;100:698–700.[Medline]
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5. Marana R, Busacca M, Zupi E, Garcea N, Paparella P, Catalano GF. Laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy: a prospective, randomized, multicenter study. Am J Obstet Gynecol 1999;180:270–5.[Medline]
6. Schutz K, Possover M, Merker A, Michels W, Schneider A. Prospective randomized comparison of laparoscopic-assisted vaginal hysterectomy (LAVH) with abdominal hysterectomy (AH) for the treatment of the uterus weighing > 200 g. Surg Endosc 2002;16:121–5.[Medline]
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8. Rosen DMB, Cario GM, Carlton MA, Lam AM, Chapman M. An assessment of the learning curve for laparoscopic and total laparoscopic hysterectomy. Gynaecol Endosc 1998;7:289–93.
9. Ikhena SE, Oni M, Naftalin NJ, Konje JC. The effect of the learning curve on the duration and peri-operative complications of laparoscopically assisted vaginal hysterectomy. Acta Obstet Gynecol Scand 1999;78:632–5.[Medline]
10. Aubard Y, Piver P, Grandjean MH, Baudet J. Laparoscopically assisted vaginal hysterectomy for non-malignant disease of the uterus: report on a personal series of 126 cases. Eur J Obstet Gynecol Reprod Biol 1996;68:147–54.[Medline]
11. Shwayder JM. The learning curve for laparoscopically assisted vaginal hysterectomy/laparoscopic hysterectomy. J Am Assoc Gynecol Laparosc 1994;1:S33.
12. Ou CS, Beadle E, Presthus J, Smith M. A multicenter review of 839 laparoscopic-assisted vaginal hysterectomies. J Am Assoc Gynecol Laparosc 1994;1:417–22.[Medline]
13. Councell RB, Thorp JM, Sandridge DA, Hill ST. Assessments of laparoscopic-assisted vaginal hysterectomy. J Am Assoc Gynecol Laparosc 1994;2:49–56.[Medline]
14. Visco AG, Barber MD, Myers ER. Early physician experience with laparoscopically assisted vaginal hysterectomy and rates of surgical complications and conversion to laparotomy. Am J Obstet Gynecol 2002;187:1008–12.[Medline]
15. Jones RA. Complications of laparoscopic hysterectomy: comparison of the first 250 cases with the second 250. Gynaecol Endosc 2000;9:373–8.
16. O'Shea RT, Petrucco OM, Gordon S, Seman E. Adelaide laparoscopic hysterectomy audit (1991-1998): realistic complication rates! In: Gynaecological endoscopy. Vol 9. Oxford (UK): Blackwell Science Ltd; 2000. p. 369–72.
17. Wattiez A, Soriano D, Cohen D, Nervo P, Canis M, Botchorishvili R, et al. The learning curve of total laparoscopic hysterectomy: comparative analysis of 1647 cases. J Am Assoc Gynecol Laparosc 2002;9:339–45.[Medline]
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