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ORIGINAL RESEARCH |
From the Department of Gynecology, Friedrich-Schiller University, Jena, Germany.
Address reprint requests to: Achim Schneider, MD, MPH Department of Gynecology Friedrich Schiller University Bachstr. 18 07740 Jena Germany E-mail: aschneider{at}bach.med.uni-jena.de
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Abstract |
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Methods: Over 4 years, 108 women had complete laparoscopic pelvic and para-aortic lymphadenectomies combined with laparoscopy-assisted radical vaginal hysterectomies for primary therapy of cervical cancer. Complete data and videotapes were available for 99 women. Operating time and radicality for specific anatomic subareas were measured by review of video documentation and histologic lymph node counts. Intra- and postoperative complications were recorded prospectively. To analyze the progress of surgery, we compared two groups of women, one operated on at the beginning of our study (early group, subjects 6–35) and one operated on in the final period of the study (late group, subjects 79–108).
Results: The operating time for pelvic and para-aortic lymphadenectomy increased constantly. Comparing the early and late groups for para-aortic lymphadenectomy, there was an increase in mean operating time (34.8 versus 73.2 minutes; P < .001) and mean histologic lymph node yield (5.1 versus 10.6; P < .001). For pelvic lymphadenectomy, mean operating time increased slightly (60.7 versus 69.7 minutes; not significant) but mean histologic lymph node count decreased over time (24.3 versus 21.0; not significant). Retrospective evaluation of videotapes showed that the radicality of lymphadenectomy improved continuously in all evaluated subareas.
Conclusion: Establishment of a protocol for para-aortic and pelvic lymphadenectomy took 100 operations. Video documentation was a more reliable indicator of progress in technical performance than were histologic lymph node counts.
Establishing a new surgical technique demands endurance and energy from patients and physicians. Operations are long, results may be suboptimal, and complications can be numerous. Tolerance for the duration of a new technique varies considerably among individuals; therefore, surgeons should have sound information about what to expect before they begin a new technique.
Experiences of others developing and using numerous new techniques have been published,1–6 but only a few studies have addressed laparoscopic lymphadenectomy in gynecologic endoscopic surgery. Operating time,7,8 hospital stays,7,8 hospital costs,7 blood loss, and conversion rates decreased8 with increasing experience of surgeons, but overall complication rates were unchanged.8 We analyzed the number of operations necessary to develop and standardize laparoscopic para-aortic and pelvic lymphadenectomy combined with radical vaginal hysterectomy in women treated for cervical cancer.
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Materials and Methods |
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The endoscopic part of each operation was videotaped (Super VHS videorecorder; Sony Corp., Tokyo, Japan). All clinical and histologic data were recorded prospectively using an Excel database (Microsoft Inc., Redmond, WA). After removal, lymph nodes were identified macroscopically by the pathologist on duty. Microscopic evaluation was done by one pathologist. Only aggregates of lymph follicles measuring more than 3 mm in diameter and surrounded by a capsule were counted as separate lymph nodes. Pathology data included histologic type and number of para-aortic and pelvic lymph nodes. We recorded preoperative and postoperative hemoglobin levels; amount of blood transfusions; duration of hospital stays; and intraoperative and postoperative complications such as bleeding, bowel obstruction, lymphedema, and lesions of the vessels, nerves, bladder, or ureter.
Duration and completeness of lymphadenectomy in the different anatomic compartments were analyzed retrospectively by independent review (CA) of videotapes. The tapes of the first five operations were not saved (subjects 1–5), and four additional tapes were lost (subjects 38, 50, 52, and 60), leaving 99 for analysis. The interval from opening the retroperitoneal space to clearing the pelvic or para-aortic region was the measure of operating time. Duration of adhesiotomy was added only if it was done during lymphadenectomy. We scored lymphadenectomies as 6 if complete, 5 if nearly complete (isolated areas of tissue remaining), 4 if good (few but confluent areas of tissue remaining), 3 if sufficient (confluent areas of tissue remaining), 2 if incomplete, or 1 if not done at all.
We analyzed the completeness of pelvic lymphadenectomies for subareas of the lateral and ventral parts of external iliac vessels from the origin of the internal iliac vessels to the hiatus inguinalis, and the cranial and caudal extent of the obturator nerve in the obturator fossa. A score between 36 (all subareas cleared completely) and 6 (all subareas on both sides not done at all) could be given when evaluating the radicality in the pelvis on both sides.
Completeness of para-aortic lymphadenectomy included the right side of the vena cava from the common iliac artery to the right ovarian vein, and the left side of the para-aortic area between the common iliac artery and the inferior mesenteric artery, which consisted of the left-sided region of the aorta, the tissue covering the caval vein caudal to the aortic bifurcation, and the presacral space caudal to the aortic and caval bifurcation and cranial to the linea terminalis. A score between 24 (all four subareas cleared completely) and 4 (all four subareas not cleared at all) could be given to evaluate radicality in the para-aortic area.
To evaluate the change in surgery, we compared an early group (subjects 6–35) operated on during the initial phase of technique development with a late group (subjects 79–108) operated on during the final phase of the study. Statistical analysis used Student t test, regression analysis, Mann-Whitney test, and Fisher exact test. To justify the number of subjects, we used the parameters 
= .05, ß = .1, and 
0 = .25, which resulted in n = 23.
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Results |
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Factors influencing lymph node yield such as age or previous conization did not differ significantly among subjects 1–20 (48.2 ± 11.4 years; 14 conizations), subjects 21–70 (47.7 ± 13.6 years; 24 conizations), and subjects 71–99 (44.0 ± 12.5 years; 16 conizations). Videotape-assessed radicality of lymphadenectomies in the six pelvic and four para-aortic subareas increased steadily throughout the study (Figures 1 and 2).
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We recorded intraoperative complications associated with laparoscopic lymphadenectomies in seven women and postoperative complications in 11 women. In the first five women, one venous and one arterial injury each required conversion to laparotomy. Subject 18 had conversion to laparotomy because of injury of the vena cava. One patient needed secondary revision because of hemorrhage. Subjects 37 and 42 had surgical revision because of bowel obstructions; one other woman with bowel obstruction was managed conservatively. There was one ureteral injury during hysterectomy and one intestinal injury. Impairment of the obturator nerve in two subjects was fully reversible. One woman had subcutaneous emphysema.
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Discussion |
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The feasibility of transperitoneal laparoscopic para-aortic lymphadenectomy was shown by Childers et al12 and Querleu and Leblanc,13 and was proved safe.14 Besides feasibility and safety, economic and oncologic factors such as duration and radicality of the procedure had to be analyzed. Experience in laparoscopic surgery shows a steady improvement in operating time, safety, and costs.2,3,8,11,12,15–17 In laparoscopic cholecystectomy, a surgeon must do ten operations to maximize operating speed without increasing complications.16 More complex procedures require more operations to perfect them. For endoscopic fundoplication, cumulative operating time drops after 25 cases, whereas the cumulative complication rate decreases after 40–60 cases.2 In endoscopic colectomy, 40–70 procedures are needed to pass the learning phase.3,17 When analyzing experiences for the first 100 laparoscopic hysterectomies, the operating technique was standardized after 50 operations while operating time continued to decrease.15 After 80 operations, mean operating time was reduced by half and was equal to that of the abdominal route. After 125 operations for laparoscopic staging of endometrial cancer, operating time still decreased, although there was no further significant drop in operating time after the 75th operation.8
In our study, overall operating time steadily increased. Most learning experiences in gynecologic laparoscopy show improvement in operating time, in contrast to our experience,8,11,12 which is explained by the increased radicality of lymphadenectomy, especially in the para-aortic area. This finding is confirmed by Childers et al,12 who reported that in 61 para-aortic lymphadenectomies, only paracaval lymph nodes were removed in the beginning; the left para-aortic side was added after surgeons had gained experience.
Our average yield of pelvic lymph nodes was 25.8 ± 8.6. Spirtos et al11 reported an average of 20.8 nodes, and Hatch et al7 harvested a mean of 35.5 nodes. Fowler et al18 showed that laparoscopic pelvic lymph node yield represented 75% of the total number found during subsequent laparotomies, whereas others reported laparoscopic lymph node discovery rates of 91%19 or 100%.20 In our study, pelvic lymph node yield increased up to subject 60, followed by a decrease. Videotape analysis showed a significant increase of lymph node harvesting for the various areas. We believe that videotape analysis is more reliable than histopathologic examination for assessing the radicality of lymphadenectomy. The discrepancy between a lower histologic versus video-documented lymph node count toward the end of the study could be explained by women in the latter part of the study having fewer lymph nodes than women in the middle phase or by a change over time in the techniques used to prepare and identify the lymph nodes by the pathologist on duty.
Fidalgo de Matos et al14 reported eight major complications (2%) in 351 laparoscopic transabdominal pelvic lymphadenectomies (one nerve injury, one ureteral lesion, four arterial injuries, one cardiac arrhythmia, and one lesion of a ligament). Excluding complications associated with radical hysterectomy, 6% of our cohort had major complications: four vessel injuries and two postoperative intra-abdominal hemorrhages requiring revision. The subjects in that study14 had only pelvic lymphadenectomies, but all of our subjects also had para-aortic lymphadenectomies, causing three of the four vessel injuries.
Childers et al12 speculated that surgeons’ improvement in laparoscopic para-aortic lymphadenectomy reaches a plateau after 20–40 procedures. Our experience shows that we needed 100 surgical procedures to implement and standardize our technique, having gained experience concomitantly in 46 subjects with endometrial cancer and four with ovarian cancer in whom we performed laparoscopic pelvic or para-aortic lymphadenectomies (data not shown).
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Footnotes |
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Received December 22, 1998. Received in revised form August 9, 1999. Accepted August 19, 1999.
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2. Meehan JJ, Georgeson KE. The learning curve associated with laparoscopic antireflux surgery in infants and children. J Pediatr Surg 1997;32:426–9.[Medline]
3. Senagore AJ, Luchtefeld MA, Mackeigan JM. What is the learning curve for laparoscopic colectomy? Am Surg 1995;61:681–5.[Medline]
4. Peters JH, Ellison EC, Innes JT, Liss JL, Nichols KE, Lomano JM, et al. Safety and efficacy of laparoscopic cholecystectomy. A prospective analysis of 100 initial patients. Ann Surg 1991;213:3–12.[Medline]
5. Dashow L, Friedman I, Kempner R, Rudick J, McSherry C. Initial experience with laparoscopic cholecystectomy at the Beth Israel Medical Center. Surg Gynecol Obstet 1992;175:25–30.[Medline]
6. Orlando R 3d, Russell JC, Lynch J, Mattie A. Laparoscopic cholecystectomy. A statewide experience. The Connecticut Laparoscopic Cholecystectomy Registry. Arch Surg 1993;128:494–8.[Abstract]
7. Hatch KD, Hallum AV, Nour M. New surgical approaches to treatment of cervical cancer. J Natl Cancer Inst Monogr 1996;21: 71–5.
8. Melendez TD, Childers JM, Nour M, Harrigill K, Surwit EA. Laparoscopic staging of endometrial cancer: The learning experience. J Soc Laparoendosc Surg 1997;1:45–9.
9. Piver MS, Rutledge F, Smith JP. Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol 1974;44:265–72.
10. Possover M, Krause N, Schneider A. Laparoscopic assistance for extended radicality of vaginal radical hysterectomy: Description of a technique. Gynecol Oncol 1998;70:94–9.[Medline]
11. Spirtos NM, Schlaerth JB, Spirtos TW, Schlaerth AC, Indman PD, Kimball RE. Laparoscopic bilateral pelvic and para-aortic lymph node sampling: An evolving technique. Am J Obstet Gynecol 1995;173:105–11.[Medline]
12. Childers JM, Hatch KD, Tran AN, Surwit EA. Laparoscopic para-aortic lymphadenectomy in gynecologic malignancies. Obstet Gynecol 1993;82:741–7.
13. Querleu D, Leblanc E. Laparoscopic infrarenal paraaortic lymph node dissection for restaging of carcinoma of the ovary or fallopian tube. Cancer 1994;73:1467–71.[Medline]
14. Fidalgo de Matos CJ, Querleu D, Leblanc E. La lymphadenectomie pelvienne endoscopique dans le bilan des cancers precoces du col uterin: Enquete aupres de 35 centres hospitaliers francais. [Pelvic endoscopic lymphadenectomy in the assessment of early cancer of the uterine neck: Survey of 25 French hospital centers]. Rev Med Brux 1993;14:163–8.[Medline]
15. Harkki-Siren P, Sjoberg J. Evaluation and the learning curve of the first one hundred laparoscopic hysterectomies. Acta Obstet Gynecol Scand 1995;74:638–41.[Medline]
16. Sariego J, Spitzer L, Matsumoto T. The "learning curve" in the performance of laparoscopic cholecystectomy. Int Surg 1993;78: 1–3.[Medline]
17. Agachan F, Joo JS, Sher M, Weiss EG, Nogueras JJ, Wexner SD. Laparoscopic colorectal surgery. Do we get faster? Surg Endosc 1997;11:331–5.[Medline]
18. Fowler JM, Carter JR, Carlson JW, Maslonkowski R, Byers LJ, Carson LF, et al. Lymph node yield from laparoscopic lymphadenectomy in cervical cancer: A comparative study. Gynecol Oncol 1993;51:187–92.[Medline]
19. Childers JM, Hatch K, Surwit EA. The role of laparoscopic lymphadenectomy in the management of cervical carcinoma. Gynecol Oncol 1992;47:38–43.[Medline]
20. Querleu D, Leblanc E, Castelain B. Lymphadenectomie pelvienne sous controle coelioscopique. [Pelvic lymphadenectomy under celioscopic guidance]. J Gynecol Obstet Biol Reprod (Paris) 1990; 19:576–8.[Medline]
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