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4. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

Author

Deijen, Charlotte L., Vasmel, Jeanine E., de Lange-de Klerk, Elly S. M., Cuesta, Miguel A., Coene, Peter-Paul L. O., Lange, Johan F., Meijerink, W. J. H. Jeroen, Jakimowicz, Jack J., Jeekel, Johannes, Kazemier, Geert, Janssen, Ignace M. C., Påhlman, Lars, Haglind, Eva, Bonjer, H. Jaap, Hellberg, R., Haglind, E., Kurlberg, G., Lindgren, P. G., Lindholm, E., Påhlman, L., Dahlberg, M., Raab, Y., Anderberg, B., Ewerth, S., Janson, M., Åkerlund, J. E., Smedh, K., Montgomery, A., Skullman, S., Nyström, P. O., Kald, A., Wänström, A., Dàlen, J., Svedberg, I., Edlund, G., Kressner, U., Öberg, A. N., Lundberg, O., Lindmark, G. E., Heikkinen, T., Morino, M., Giraudo, G., Lacy, A. M., Delgado, S., Macarulla Sanz, E., Díez, J. Medina, Schwandner, O., Schiedeck, T. H., Shekarriz, H., Bloechle, C., Baca, I., Weiss, O., Msika, S., Desvignes, G., Campbell, K. L., Cuschieri, A., Bonjer, H. J., Schouten, W. R., Kazemier, G., Lange, J. F., van der Harst, E., Coene, P. P. L. O., Plaisier, P., Bertleff, M. J. O. E., Cuesta, M. A., van der Broek, W., Meijerink, W. J. H. J., Jakimowicz, J. J., Nieuwenhuijzen, G., Maring, J., Kivit, J., Janssen, I. M. C., Spillenaar-Bilgen, E. J., Berends, F., and On behalf of the COLOR (COlon cancer Laparoscopic or Open Resection) study group

Published
2017
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6. The EAES Clinical Practice Guidelines on Laparoscopic Resection of Colonic Cancer (2004)

Author

Veldkamp, Ruben, Gholghesaei, M., Bonjer, H.Jaap, Meijer, Dirk W., Buunen, M., Jeekel, J., Anderberg, B., Cuesta, M.A., Cuschieri, Alfred, Fingerhut, Abe, Fleshman, J.W., Guillou, P.J., Haglind, E., Himpens, J., Jacobi, Christoph A., Jakimowicz, J.J., Koeckerling, Ferdinand, Lacy, Antonio M., Lezoche, Emilio, Monson, John R.T., Morino, Mario, Neugebauer, Edmund A.M., Wexner, S.D., Whelan, R.L., Neugebauer, E.A.M., editor, Sauerland, S., editor, Fingerhut, A., editor, Millat, B., editor, and Buess, G., editor

Published
2006
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7. Colonic Cancer – Update 2006

Author

Veldkamp, Ruben, Gholghesaei, M., Bonjer, H.Jaap, Meijer, Dirk W., Buunen, M., Jeekel, J., Anderberg, B., Cuesta, M.A., Cuschieri, Alfred, Fingerhut, Abe, Fleshman, J.W., Guillou, P.J., Haglind, E., Himpens, J., Jacobi, Christoph A., Jakimowicz, J.J., Koeckerling, Ferdinand, Lacy, Antonio M., Lezoche, Emilio, Monson, John R.T., Morino, Mario, Neugebauer, Edmund A.M., Wexner, S.D., Whelan, R.L., Neugebauer, E.A.M., editor, Sauerland, S., editor, Fingerhut, A., editor, Millat, B., editor, and Buess, G., editor

Published
2006
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20. Laparoscopic resection of colon Cancer: Consensus of the European Association of Endoscopic Surgery (EAES)

Author

Veldkamp, R., Gholghesaei, M., Bonjer, H. J., Meijer, D. W., Buunen, M., Jeekel, J., Anderberg, B., Cuesta, M. A., Cuschierl, A., Fingerhut, A., Fleshman, J. W., Guillou, P. J., Haglind, E., Himpens, J., Jacobi, C. A., Jakimowicz, J. J., Koeckerling, F., Lacy, A. M., Lezoche, E., Monson, J. R., Morino, M., Neugebauer, E., Wexner, S. D., and Whelan, R. L.

Published
2004
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31. Residual/recurrent disease and deaths at 6 years after open or robotic-assisted radical prostatectomy in the prospective, controlled trial LAPPRO

Author

Nyberg, M.P., primary, Akre, O., additional, Bock, D., additional, Carlsson, S.V., additional, Carlsson, S., additional, Hugosson, J., additional, Steineck, G., additional, Stranne, J., additional, Tyritzis, S., additional, Wiklund, P., additional, Haglind, E., additional, and Bjartell, A.S., additional

Published
2020
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32. Risk of hernia formation after radical prostatectomy: a comparison between open and robot-assisted laparoscopic radical prostatectomy within the prospectively controlled LAPPRO trial

Author

Nilsson, H., primary, Stranne, J., additional, Hugosson, J., additional, Wessman, C., additional, Steineck, G., additional, Bjartell, A., additional, Carlsson, S., additional, Thorsteinsdottir, T., additional, Tyritzis, S. I., additional, Lantz, A., additional, Wiklund, P., additional, and Haglind, E., additional

Published
2020
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36. American Society of Colon and Rectal Surgeons 91st Annual Convention Podium and Poster abstracts: June 7–12, 1992 San Francisco, CA

Author

Lechner, P., Lind, P., Binter, G., Golub, R. W., Kerner, B. A., Wise, Jr., W. E., Meesig, D. M., Hartmann, R. F., Khanduja, K. S., Sayre, J. W., Aguilar, P. S., Guillem, J. G., Forde, K. A., Treat, M. R., Neugut, A. I., O'Toole, K. M., Diamond, B. E., Kewenter, J., Brevinge, H., Haglind, E., Limberg, B., Elles, C. N., Boggs, W. H., Slagle, G. H., Cole, P. A., Coyle, D. J., Smith, L. E., Orkin, B., Saclarides, T. J., Sheridan, W. G., Lowndes, R. H., Young, H. L., Wong, W. D., Rothenberger, D. A., Bartolo, D. C. C., Wexner, S. D., Ger, G. C., Jorge, J. M. N., Lee, E., Nogueras, J. J., Jagelman, D. G., McKenna, K., Koltun, W. A., Bute, B., Lichliter, W., Le, T., Timmcke, A., Gathright, J. B., Mascagni, D., Hojo, K., Moriya, Y., Sugihara, K., Di, G., Zenni, G. C., Abraham, K., Dobrin, P. B., Harford, F. J., Suzuki, K., Gunderson, L., Devine, R. M., Dozois, R. R., Cavaliere, F., Pemberton, J. H., Fazio, V., Cosimelli, M., Beart, R. W., Giannarelli, D., Moran, M., Ramos, A., Rothenberger, D., Goldberg, S., Antonenko, D., Heymen, S., Gulledge, A. D., Jakate, S., Saclarides, T., Heine, J. A., Williams, J. G., VanBergen, E. H., Buie, W. D., Goldberg, S. M., Davies, N., Yates, J., Jenkins, S. A., Taylor, B. A., Bapat, B., Stern, H., Berk, T., Parker, J., Ray, P. N., McLeod, R., Cohen, Z., Rowe, J. K., Zera, R. T., Madoff, R. D., Bubrick, M. P., Roberts, J. C., Johnston, G. R., Fenney, D. A., Farouk, R., Duthie, G. S., McCue, J. L., Phillips, R. K. S., Viamonte, M., Cole, J., Gottesman, L., Solomon, M. J., McLeod, R. S., Kern, K., Jensen, L. L., Lowry, A. C., Vernava, III, A. M., Longo, W. E., Daniel, G. L., Ehrenpreis, E., Stone, J. M., Cosman, B. C., Wolfe, V. A., Nino-Murcia, M., Perkash, I., Marcello, P. W., Roberts, P. L., Schoetz, Jr., D. J., Murray, J. J., Coller, J. A., Veidenheimer, M. C., Keighley, M. R. B., Grobler, S. P., Hosie, K. B., Schmitt, S. L., James, K., Lucas, F., Peck, Donald A., Ferrara, A., Grotz, R. L., Perry, R. E., Hanson, R. B., Lewis, W. G., Holdsworth, P. J., Sagar, P. M., Johnston, D., Perry, T. G., Strong, S. A., Fazio, V. W., Lavery, I. C., Oakley, J. R., Church, J. M., Milsom, J. W., Fozard, J. B. J., Nelson, H., Schneebaum, S., Arnold, M. W., Young, D., LaValle, G. J., Petty, L., Berens, A., Mojizisik, C., Martin, E. W., Hase, K., Shatney, C. H., Trollope, M., Johnson, D., Vierra, M., Deutsch, A. A., Tulchinsky, H., Nudelman, I., Gutman, H., Reiss, R., Taylor, Brian M., Araujo, A., Bleday, R., Jessurun, J., Heine, J., Rosen, Les, Sipe, Paul, Riether, Robert, Stasik, John, Sheets, James, Khubchandani, Indru, Reiter, W., Friedberg, G., Morey, G., Goldstein, E., Williamson, P., Larach, S., Senagore, A. J., Luchtefeld, M. A., MacKeigen, J. M., Mazier, W. P., Wengert, T., Ott, M. T., Bailey, H. R., Hartendorp, P., Dailey, T. H., Church, J. C., Johansen, O. B., Daniel, N., Korst, M., Kuijpers, H. C., Pena, J. P., Christenson, C. E., Balcos, E. G., Lewis, W., Mitchell, C., MacFie, J., Hildebrandt, U., Ecker, K. W., Kraus, J., Schmid, T., Feifel, G., Tjandra, J. J., Scoggin, Steve, Frazee, Richard C., Ambroze, Jr., W. L., Nezhat, C., Pennington, E., Nezhat, F., Stolfi, V. M., Thorson, A. G., Falk, P. M., Fitzgibbons, Jr, R. J., Luukkonen, P., Järvinen, H. J., James, E., Paty, P. B., Enker, W. E., Cohen, A. M., Lauwers, G. Y., Saad, R., Birnbaum, E., DeVos, W., Fry, R., Kodner, I., Fleshman, J., Cali, R. L., Pitsch, R. M., Blatchford, G. J., Christensen, M. A., Schroeder, T. K., Easley, K. A., Ellis, C. N., Cheape, J. D., Hull, T. L., Salanga, V., Kokoszka, Joseph, Andrianopoulos, Georgia, Nelson, Richard, Abcarian, Herand, Kumar, D., Benson, M. J., Roberts, J., Martin, J. E., Swash, M., Wingate, D. L., Williams, N. S., Orkin, B. A., Emsellem, H., Dent, John, Tissaw, M. A., Shafik, A., Abel, M. E., Chiu, Y. S. Y., Russell, T. R., Volpe, P. A., Casillas, G. L., Mashas, W. E., Eastman, D. A., Grace, R. H., Anderson, J. M., Hacker, K., Heryer, J., Conner, W., Rubin, R., Eisenstat, T., Salvati, E., Oliver, G., Duberman, E., Simmang, C. L., Fry, R. D., Kodner, I. J., Fleshman, J. W., Corman, M. L., Galandiuk, S., Weiner, G. J., Kahn, D., Mitchell, E., Abdel-Nabi, H., Block, G. E., Mannella, E., Tedesco, M., Anza, M., Civalleri, D., Di Tora, P., Capussotti, L., Morandi, G. B., Tirelli, C., Da Pian, P. P., Cortesi, E., Ruggeri, E., Fitzgerald, S. D., Davis, Faith, Bowen, Phyllis, Sutter, Eileen, Kikendall, Walter, McGannon, E., Brantley, P. A., Czyrko, C., Falardeau, C., Trepashko, Don, Skosey, John, Michelassi, F., Staniunas, R. J., Vignati, P. V., Beck, D. E., Karulf, R., Roettger, R., Braidt, J., Ruoff, K., Ackroyd, F., Shellito, P., Goh, H. S., Lin, L. W., Edwards, E., Farmer, J., Walters, C. A., Hyman, N. H., Hebert, J. C., Richman, Irving M., Staren, E. D., Sessions, S. C., Scoma, R. S., Clements, B., Smink, Jr., R. D., Arai, K., Sugita, A., Yamazaki, Y., Harada, H., Fukushima, T., Armstrong, D. N., Ballantyne, G. H., Sillin, L. F., Davie, R. J., Harding, L. K., Birch, N. J., Yamanouchi, T., Bayer, I., Mitmaker, B., Gordon, P. H., Wang, E., Kynaston, H., Edelstein, P. S., Thompson, S. M., Davies, R. J., Farmer, K. C. R., Oliver, S. E., Spigelman, A. D., Bennett, P., O'Kelly, T. J., Brading, A. F., Mortensen, N. J., Paul, P., McGannon, E. M., Huth, P., Hull-Boiner, S., Pezim, M. E., Johnson, H. W., Gillespie, K. D., Willard, P., Owen, D. A., Ramsey, P. S., Leu, S. Y., Hsu, H., Al-Humadi, Adil H., Eisman, E., Tries, J., Gupta, N. C., Frick, M. P., Boman, B. M., Franceschi, D., Eckhauser, M. L., Pritchard, T., Konsten, J., Baeten, C. G. M. I., Havenith, M. G., Soeters, P. B., Lau, P. W. K., Lorentz, T. G., Wong, J., and The III In-CYT-103 Immunoscintigraphy Study Group

Published
1992
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40. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial)

Author

Park, J, Danielsen, A K, Angenete, E, Bock, D, Marinez, A C, Haglind, E, Jansen, J E, Skullman, S, Wedin, A, and Rosenberg, J

Subjects
Adult, Aged, 80 and over, Male, Postoperative Complications/epidemiology, Time Factors, Ileostomy, Middle Aged, humanities, Rectal Neoplasms/surgery, Quality of Life, Health Status Indicators, Humans, Female, Rectum/surgery, Aged, Follow-Up Studies
Abstract

BACKGROUND: A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy.METHODS: Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Inclusion of participants was made after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1-4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®).RESULTS: There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12 months, to which only 54-55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months.CONCLUSION: Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 (https://www.clinicaltrials.gov).

Published
2018

42. Two-year results of the randomized clinical trial DILALA comparing laparoscopic lavage with resection as treatment for perforated diverticulitis

Author

Kohl, A, Rosenberg, J, Bock, D, Bisgaard, T, Skullman, S, Thornell, A, Gehrman, J, Angenete, E, Haglind, E, Kohl, A, Rosenberg, J, Bock, D, Bisgaard, T, Skullman, S, Thornell, A, Gehrman, J, Angenete, E, and Haglind, E

Abstract

BACKGROUND: Traditionally, perforated diverticulitis with purulent peritonitis was treated with resection and colostomy (Hartmann's procedure), with inherent complications and risk of a permanent stoma. The DILALA (DIverticulitis - LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) and other randomized trials found laparoscopic lavage to be a feasible and safe alternative. The medium-term follow-up results of DILALA are reported here.METHODS: Patients were randomized during surgery after being diagnosed with Hinchey grade III perforated diverticulitis at diagnostic laparoscopy. The primary outcome was the proportion of patients with one or more secondary operations from 0 to 24 months after the index procedure in the laparoscopic lavage versus Hartmann's procedure groups. The trial was registered as ISRCTN82208287.RESULTS: Forty-three patients were randomized to laparoscopic lavage and 40 to Hartmann's procedure. Patients in the lavage group had a 45 per cent reduced risk of undergoing one or more operations within 24 months (relative risk 0·55, 95 per cent c.i. 0·36 to 0·84; P = 0·012) and had fewer operations (ratio 0·51, 95 per cent c.i. 0·31 to 0·87; P = 0·024) compared with those in the Hartmann's group. No difference was found in mean number of readmissions (1·37 versus 1·50; P = 0·221) or mortality between patients randomized to laparoscopic lavage or Hartmann's procedure. Three patients in the lavage group and nine in the Hartmann's group had a colostomy at 24 months.CONCLUSION: Laparoscopic lavage is a better option for perforated diverticulitis with purulent peritonitis than open resection and colostomy.

Published
2018

43. Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial.

Author

Heiman, J., Onerup, A., Wessman, C., Haglind, E., and Bagge, R. Olofsson

Subjects
BREAST cancer surgery, PHYSICAL activity, CLINICAL trials, PATIENT readmissions
Abstract

Background: The effect of preoperative physical activity on recovery and complications after primary breast cancer surgery is unknown. The objective of this trial was to evaluate whether a recommendation of non-supervised physical activity improved recovery after breast cancer surgery. Methods: This parallel, unblinded, multicentre interventional trial randomized women in whom breast cancer surgery was planned. The intervention consisted of an individual recommendation of added aerobic physical activity (30 min/day), before and 4 weeks after surgery. The control group did not receive any advice regarding physical activity. The primary outcome was patient-reported physical recovery at 4 weeks after surgery. Secondary outcomes included mental recovery, complications, reoperations, and readmissions. Results: Between November 2016 and December 2018, 400 patients were randomized, 200 to each group. Some 370 participants (180 intervention, 190 control) remained at 4 weeks, and 368 at 90 days. There was no significant difference in favour of the intervention for the primary outcome physical recovery (risk ratio (RR) 1.03, 95 per cent c.i. 0.95 to 1.13). There was also no difference for mental recovery (RR 1.05, 0.93 to 1.17) nor in mean Comprehensive Complication Index score (4.2 (range 0-57.5) versus 4.7 (0-58.3)) between the intervention and control groups. Conclusion: An intervention with recommended non-supervised physical activity before and after breast cancer surgery did not improve recovery at 4 weeks after surgery. [ABSTRACT FROM AUTHOR]

Published
2021
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47. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

Author

Deijen, C.L., Vasmel, J.E., Lange-de Klerk, E.S. de, Cuesta, M.A., Coene, P.L.O., Lange, J.F., Meijerink, W.J.H.J., Jakimowicz, J.J., Jeekel, J., Kazemier, G., Pahlman, L., Haglind, E., Bonjer, H.J., Deijen, C.L., Vasmel, J.E., Lange-de Klerk, E.S. de, Cuesta, M.A., Coene, P.L.O., Lange, J.F., Meijerink, W.J.H.J., Jakimowicz, J.J., Jeekel, J., Kazemier, G., Pahlman, L., Haglind, E., and Bonjer, H.J.

Abstract

Contains fulltext : 174511.pdf (publisher's version ) (Open Access), BACKGROUND: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up. METHODS: Between March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842). RESULTS: In total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) -10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI -10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI -11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4). CONCLUSIONS: Laparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery at 1

Published
2017

48. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

Author

Deijen, CL, Vasmel, JE, de Lange-de Klerk, ESM, Cuesta, MA, Coene, P, Lange, Johan, Meijerink, W, Jakimowicz, JJ, Jeekel, J (Hans), Kazemier, G, Janssen, IMC, Pahlman, L, Haglind, E, Bonjer, HJ, Deijen, CL, Vasmel, JE, de Lange-de Klerk, ESM, Cuesta, MA, Coene, P, Lange, Johan, Meijerink, W, Jakimowicz, JJ, Jeekel, J (Hans), Kazemier, G, Janssen, IMC, Pahlman, L, Haglind, E, and Bonjer, HJ

Published
2017

50. Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial

Author

Gehrman, J., Angenete, E, Björholt, I., Bock, David, Rosenberg, J., and Haglind, E

Abstract

Background: Open surgery with resection and colostomy (Hartmann's procedure) has been the standard treatment for perforated diverticulitis with purulent peritonitis. In recent years laparoscopic lavage has emerged as an alternative, with potential benefits for patients with purulent peritonitis, Hinchey grade III. The aim of this study was to compare laparoscopic lavage and Hartmann's procedure with health economic evaluation within the framework of the DILALA (DIverticulitis – LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) trial. Methods: Clinical effectiveness and resource use were derived from the DILALA trial and unit costs from Swedish sources. Costs were analysed from the perspective of the healthcare sector. The study period was divided into short-term analysis (base-case A), within 12 months, and long-term analysis (base-case B), from inclusion in the trial throughout the patient's expected life. Results: The study included 43 patients who underwent laparoscopic lavage and 40 who had Hartmann's procedure in Denmark and Sweden during 2010–2014. In base-case A, the difference in mean cost per patient between laparoscopic lavage and Hartmann's procedure was €–8983 (95 per cent c.i. –16 232 to –1735). The mean(s.d.) costs per patient in base-case B were €25 703(27 544) and €45 498(38 928) for laparoscopic lavage and Hartmann's procedure respectively, resulting in a difference of €–19 794 (95 per cent c.i. –34 657 to –4931). The results were robust as demonstrated in sensitivity analyses. Conclusion: The significant cost reduction in this study, together with results of safety and efficacy from RCTs, support the routine use of laparoscopic lavage as treatment for complicated diverticulitis with purulent peritonitis.

Published
2016

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