Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial
Summary Background The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assu...
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| creator | Mourits, Marian JE, Prof Bijen, Claudia B, MD Arts, Henriëtte J, PhD ter Brugge, Henk G, MD van der Sijde, Rob, MD Paulsen, Lasse, MD Wijma, Jacobus, PhD Bongers, Marlies Y, PhD Post, Wendy J, PhD van der Zee, Ate G, Prof de Bock, Geertruida H, Prof |
| description | Summary Background The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. Methods This randomised trial was done in 21 hospitals in the Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry , number NTR821. Findings The proportion of major complications was 14·6% (27 of 185) in the TLH group versus 14·9% (14 of 94) in the TAH group, with a difference of −0·3% (95% CI −9·1 to 8·5; p=0·95). The proportion of patients with an intraoperative major complication (nine of 279 [3·2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11·5%]) and did not differ between TLH (five of 185 [2·7%]) and TAH (four of 94 [4·3%]; p=0·49). The proportion of patients with a minor complication was 13·0% (24 of 185) in the TLH group and 11·7% (11 of 94) in the TAH group (p=0·76). Conversion to laparotomy occurred in 10·8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p |
| doi_str_mv | 10.1016/S1470-2045(10)70143-1 |
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Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. Methods This randomised trial was done in 21 hospitals in the Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry , number NTR821. Findings The proportion of major complications was 14·6% (27 of 185) in the TLH group versus 14·9% (14 of 94) in the TAH group, with a difference of −0·3% (95% CI −9·1 to 8·5; p=0·95). The proportion of patients with an intraoperative major complication (nine of 279 [3·2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11·5%]) and did not differ between TLH (five of 185 [2·7%]) and TAH (four of 94 [4·3%]; p=0·49). The proportion of patients with a minor complication was 13·0% (24 of 185) in the TLH group and 11·7% (11 of 94) in the TAH group (p=0·76). Conversion to laparotomy occurred in 10·8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0·0001), less use of pain medication (p<0·0001), a shorter hospital stay (p<0·0001), and a faster recovery (p=0·002), but the procedure took longer than TAH (p<0·0001). Interpretation Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities. Funding The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(10)70143-1</identifier><identifier>PMID: 20638901</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Carcinoma, Endometrioid - pathology ; Carcinoma, Endometrioid - surgery ; Endometrial Hyperplasia - pathology ; Endometrial Hyperplasia - surgery ; Endometrial Neoplasms - pathology ; Endometrial Neoplasms - surgery ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Hysterectomy - adverse effects ; Hysterectomy - methods ; Intention to Treat Analysis ; Intraoperative Complications ; Laparoscopy - adverse effects ; Laparotomy - adverse effects ; Length of Stay ; Middle Aged ; Netherlands ; Ovariectomy - adverse effects ; Ovariectomy - methods ; Postoperative Complications ; Quality of Life ; Safety</subject><ispartof>The lancet oncology, 2010-08, Vol.11 (8), p.763-771</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Aug 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-9bccda5f7f7936c439f8501c88e81ef61aab0396597ef2ff520f4d533a242c503</citedby><cites>FETCH-LOGICAL-c498t-9bccda5f7f7936c439f8501c88e81ef61aab0396597ef2ff520f4d533a242c503</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1470204510701431$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20638901$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mourits, Marian JE, Prof</creatorcontrib><creatorcontrib>Bijen, Claudia B, MD</creatorcontrib><creatorcontrib>Arts, Henriëtte J, PhD</creatorcontrib><creatorcontrib>ter Brugge, Henk G, MD</creatorcontrib><creatorcontrib>van der Sijde, Rob, MD</creatorcontrib><creatorcontrib>Paulsen, Lasse, MD</creatorcontrib><creatorcontrib>Wijma, Jacobus, PhD</creatorcontrib><creatorcontrib>Bongers, Marlies Y, PhD</creatorcontrib><creatorcontrib>Post, Wendy J, PhD</creatorcontrib><creatorcontrib>van der Zee, Ate G, Prof</creatorcontrib><creatorcontrib>de Bock, Geertruida H, Prof</creatorcontrib><title>Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Summary Background The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. Methods This randomised trial was done in 21 hospitals in the Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry , number NTR821. Findings The proportion of major complications was 14·6% (27 of 185) in the TLH group versus 14·9% (14 of 94) in the TAH group, with a difference of −0·3% (95% CI −9·1 to 8·5; p=0·95). The proportion of patients with an intraoperative major complication (nine of 279 [3·2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11·5%]) and did not differ between TLH (five of 185 [2·7%]) and TAH (four of 94 [4·3%]; p=0·49). The proportion of patients with a minor complication was 13·0% (24 of 185) in the TLH group and 11·7% (11 of 94) in the TAH group (p=0·76). Conversion to laparotomy occurred in 10·8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0·0001), less use of pain medication (p<0·0001), a shorter hospital stay (p<0·0001), and a faster recovery (p=0·002), but the procedure took longer than TAH (p<0·0001). Interpretation Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities. Funding The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Carcinoma, Endometrioid - pathology</subject><subject>Carcinoma, Endometrioid - surgery</subject><subject>Endometrial Hyperplasia - pathology</subject><subject>Endometrial Hyperplasia - surgery</subject><subject>Endometrial Neoplasms - pathology</subject><subject>Endometrial Neoplasms - surgery</subject><subject>Female</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Hysterectomy - adverse effects</subject><subject>Hysterectomy - methods</subject><subject>Intention to Treat Analysis</subject><subject>Intraoperative Complications</subject><subject>Laparoscopy - adverse effects</subject><subject>Laparotomy - adverse effects</subject><subject>Length of Stay</subject><subject>Middle Aged</subject><subject>Netherlands</subject><subject>Ovariectomy - 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pathology</topic><topic>Carcinoma, Endometrioid - surgery</topic><topic>Endometrial Hyperplasia - pathology</topic><topic>Endometrial Hyperplasia - surgery</topic><topic>Endometrial Neoplasms - pathology</topic><topic>Endometrial Neoplasms - surgery</topic><topic>Female</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Hysterectomy - adverse effects</topic><topic>Hysterectomy - methods</topic><topic>Intention to Treat Analysis</topic><topic>Intraoperative Complications</topic><topic>Laparoscopy - adverse effects</topic><topic>Laparotomy - adverse effects</topic><topic>Length of Stay</topic><topic>Middle Aged</topic><topic>Netherlands</topic><topic>Ovariectomy - adverse effects</topic><topic>Ovariectomy - methods</topic><topic>Postoperative Complications</topic><topic>Quality of Life</topic><topic>Safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mourits, Marian JE, Prof</creatorcontrib><creatorcontrib>Bijen, Claudia B, MD</creatorcontrib><creatorcontrib>Arts, Henriëtte J, PhD</creatorcontrib><creatorcontrib>ter Brugge, Henk G, MD</creatorcontrib><creatorcontrib>van der Sijde, Rob, MD</creatorcontrib><creatorcontrib>Paulsen, Lasse, MD</creatorcontrib><creatorcontrib>Wijma, Jacobus, PhD</creatorcontrib><creatorcontrib>Bongers, Marlies Y, PhD</creatorcontrib><creatorcontrib>Post, Wendy J, PhD</creatorcontrib><creatorcontrib>van der Zee, Ate G, Prof</creatorcontrib><creatorcontrib>de Bock, Geertruida H, Prof</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>The lancet oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mourits, Marian JE, Prof</au><au>Bijen, Claudia B, MD</au><au>Arts, Henriëtte J, PhD</au><au>ter Brugge, Henk G, MD</au><au>van der Sijde, Rob, MD</au><au>Paulsen, Lasse, MD</au><au>Wijma, Jacobus, PhD</au><au>Bongers, Marlies Y, PhD</au><au>Post, Wendy J, PhD</au><au>van der Zee, Ate G, Prof</au><au>de Bock, Geertruida H, Prof</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2010-08-01</date><risdate>2010</risdate><volume>11</volume><issue>8</issue><spage>763</spage><epage>771</epage><pages>763-771</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><coden>LANCAO</coden><abstract>Summary Background The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. Methods This randomised trial was done in 21 hospitals in the Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry , number NTR821. Findings The proportion of major complications was 14·6% (27 of 185) in the TLH group versus 14·9% (14 of 94) in the TAH group, with a difference of −0·3% (95% CI −9·1 to 8·5; p=0·95). The proportion of patients with an intraoperative major complication (nine of 279 [3·2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11·5%]) and did not differ between TLH (five of 185 [2·7%]) and TAH (four of 94 [4·3%]; p=0·49). The proportion of patients with a minor complication was 13·0% (24 of 185) in the TLH group and 11·7% (11 of 94) in the TAH group (p=0·76). Conversion to laparotomy occurred in 10·8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0·0001), less use of pain medication (p<0·0001), a shorter hospital stay (p<0·0001), and a faster recovery (p=0·002), but the procedure took longer than TAH (p<0·0001). Interpretation Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities. Funding The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>20638901</pmid><doi>10.1016/S1470-2045(10)70143-1</doi><tpages>9</tpages></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Carcinoma, Endometrioid - pathology Carcinoma, Endometrioid - surgery Endometrial Hyperplasia - pathology Endometrial Hyperplasia - surgery Endometrial Neoplasms - pathology Endometrial Neoplasms - surgery Female Hematology, Oncology and Palliative Medicine Humans Hysterectomy - adverse effects Hysterectomy - methods Intention to Treat Analysis Intraoperative Complications Laparoscopy - adverse effects Laparotomy - adverse effects Length of Stay Middle Aged Netherlands Ovariectomy - adverse effects Ovariectomy - methods Postoperative Complications Quality of Life Safety |
| title | Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial |
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