經口膽囊移除引起一些不良反應


  April 15, 2008 (費城) — 芝加哥西北大學與波特蘭Legacy健康體系的外科醫師在美國腸胃道與內視鏡外科醫師學會2008年會暨畢業後課程中,報告最初的7例人類的經胃自然管口內視鏡手術(natural orifice transluminal surgery,NOTES)膽囊切除術。
  
  NOTES方式背後的觀念是運用人體的自然開口取出目標器官,外科醫師可以穿過內部組織障礙到達這些器官,病患不會有體外疤痕且疼痛減少許多。
  
  迄今,在人類進行的大部分NOTES手術是經由陰道,不過,本研究的共同主要研究者、西北大學外科主任Nathaniel Soper醫師向Medscape General Surgery表示,這只是因為另一個性別的人無法運用此種經陰道方法;他指出,有些婦女對於經陰道手術感到不舒適,此外,他觀察發現,因為胃部原本就是無菌區域,通過胃部比通過直腸更有意義。
  
  因為使用NOTES進行膽囊切除術須在疾病早期,該研究的人體試驗委員會(Institutional Review Board,IRB)需要讓每個病患有至少一個腹腔鏡開孔,以監控手術的安全性,且確定胃部的洞可以被關閉。
  
  Soper醫師表示,IRB需要病患住院過夜,但是這些外科醫師可以進行門診手術;此外,大部分病患不需要止痛藥物,病患只在腹腔鏡開口部位感到疼痛。
  
  會議主持人、梅約診所外科主任C. Daniel Smith醫師對 NOTES 抱持懷疑,雖然他向Medscape General Surgery 提到此研究設計良好,且納入的病患沒有顯著併發症,但他指出,樣本太少,難以獲得NOTES與腹腔鏡手術比較的結論;事實上,Smith醫師觀察指出,證明NOTES優於腹腔鏡的門檻仍相當高。
  
  Smith醫師指出,接受腹腔鏡手術的病患有比較短的住院天數,疼痛復原較佳,即使小改善的病患也相當多。
  
  Smith醫師質疑醫師有充分理由轉變為使用NOTES,因為目前只是預期這個手術會有好的結果而已。
  
  不過,Smith醫師承認,如果NOTES可以有腹腔鏡無法進入的入口,如上胸腔壁,那麼NOTES就會有真正的價值。
  
  本研究的另一名主要作者、Legacy健康體系的Lee Swanström博士在會議中表示,有超過預期人數兩倍的病患自願參與研究,而病患排除理由之一是心智穩定度;他指出,透過網際網路知道研究訊息的病患比較不穩定,且該研究正在尋找基金支持,因為保險公司拒絕給付奧勒岡州的病患。
  
  本研究接受多家保險公司、USGI, Covidien, Power Medical, Karl Storz Endoscopy America以及支持建立實驗室的Ethicon Endo-Surgery公司的資金;Soper 醫師接受來自Covidien的基金且是Covidie、Ethicon Endo-Surgery公司以及 USGI Medical的倫理諮詢委員會成員。Smith醫師宣稱沒有相關資金往來。Swanström醫師接受USGI Medical、Boston Scientific以及 Olympus Surgical America的研究支持;也是USGI Medical的顧問;擔任Ethicon Endo-Surgery的發言人/講師。
  
  美國腸胃道與內視鏡外科醫師學會2008年會暨畢業後課程:摘要 S034。發表於2008年4月9–12。

Gallbladder Removal Through th

By
Medscape Medical News

April 15, 2008 (Philadelphia) — Surgeons from the Legacy Health System in Portland, Oregon, and Northwestern University in Chicago, Illinois, reported on the first 7 transgastric natural orifice transluminal surgery (NOTES) cholecystectomies ever performed on humans here at the Society of American Gastrointestinal and Endoscopic Surgeons 2008 Annual Scientific Session and Postgraduate Course.

The thinking behind the NOTES approach is that by using the body's orifices to get close to target organs, the surgeon can perforate the internal tissue barriers to these organs. Patients would experience no external scarring and much diminished levels of pain.

Until now, most NOTES operations performed on humans have been transvaginal. However, as Nathaniel Soper, MD, chair of surgery at Northwestern University and coprincipal investigator of the study, told Medscape General Surgery, this is simply "not applicable to half the population." He added that some women are uncomfortable with transvaginal procedures. In addition, he observed that because the stomach is a naturally sterile area, "going through the stomach makes more sense than going through, for example, the rectum."

Because the use of NOTES for cholecystectomy is in such an early stage of development, the study's institutional review board (IRB) required that each patient have at least 1 laparoscopic port to monitor the procedure's safety and to assess that the hole in the stomach was closed securely.

Dr. Soper said that the IRB required that patients stay in hospital overnight but that these surgeries could have been outpatient procedures. In addition, most of the patients did not require any pain medication. The pain that patients did experience was located around the laparoscopic ports.

The session moderator, C. Daniel Smith, MD, FACS, chair of the Department of Surgery, Mayo Clinic, Jacksonville, Florida, is a NOTES skeptic. Although he acknowledged to Medscape General Surgery that the study was well designed and that the patients enrolled did not experience any significant complications, he noted that the sample size was too small to come to any conclusion about how NOTES compares with laparoscopic surgery. In fact, Dr. Smith observed that the obstacles to proving NOTES superior to the laparoscopic approach will be high.

"[Patients who undergo] laparoscopic procedures," Dr. Smith noted, "have such a short length of stay in the hospital and such a favorable recovery in terms of pain, it may take a huge number of patients to show even minor improvements."

Dr. Smith doubts that surgeons will have a compelling reason to switch to NOTES, because right now they have a readily available procedure with "exceptionally good outcomes."

However, Dr. Smith conceded that if NOTES can access places, such as the upper chest wall, that laparoscopic techniques cannot, then NOTES will have real value.

Lee Swanström, MD, PhD, from Legacy Health System, the study's other principal investigator, told the session that twice as many patients volunteered for the study as were accepted. One reason for patient exclusion was mental stability. He noted that the chances of instability in patients who learn of a study through the Internet can be high and mentioned that the study was looking for more funding because insurance companies are refusing coverage to Oregon patients.

This study was funded by various insurance companies, USGI, Covidien, Power Medical, Karl Storz Endoscopy America, and Ethicon Endo-Surgery Inc, who assisted in the laboratory. Dr. Soper has received funding from Covidien and has been on the ethical advisory boards of Covidien, Ethicon Endo-Surgery Inc, and USGI Medical. Dr. Smith has disclosed no relevant financial relationships. Dr. Swanström receives research support from USGI Medical, Boston Scientific, and Olympus Surgical America; is a consultant with USGI Medical; and was a speaker/teacher for Ethicon Endo-Surgery.

Society of American Gastrointestinal and Endoscopic Surgeons 2008 Annual Scientific Session and Postgraduate Course: Abstract S034. Presented April 9–12, 2008.

    
相關報導
SNM 2009:膽囊排出率高的病患可進行手術
2009/7/15 下午 02:34:00
SAGES 2009:人體研究發現混合型經陰道膽囊切除術是安全的
2009/5/7 上午 10:25:00

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