調查評估減重醫師對腔內手術的預期及風險耐受


  June 23, 2008 (華盛頓特區) — 根據美國代謝與減重外科學會(ASMBS)第25屆年會中發表的調查結果,相較於初版腔內手術,減重外科醫師或許願意接受減重較少且風險較多的修定版,這結果顯示體重減輕程度和風險接受度是目前減重腔內手術的發展考量。
  
  問卷由ASMBS緊急技術委員會發展,分發給該學會會員;16%完成且回覆(n= 214),評估五種常見手術的風險:診斷式內視鏡檢查(視為低風險)、內視鏡息肉切除術、內視鏡逆行性胰膽管攝影、腹腔鏡可調式胃束帶手術 、以及腹腔鏡Roux-en-Y 胃繞道手術(視為高風險)。
  
  發表人、克里夫蘭診所一般外科進階腹腔鏡與減重手術小組的Stacy A. Brethauer醫師向Medscape General Surgery表示,一般來說,我認為這些腔內手術的風險考量相當低,因此我們評估風險,但主要是比較對於初版和修正版風險利益比的耐受度。
  
  有關風險的調查問題包括:
  * 對於在一年時達到10%-20%過量體重減輕(EWL)的修正版腔內手術風險程度可以接受到哪種程度?如果一年時達到30%-40% EWL又如何?
  * 對於在一年時達到10%-20%EWL的初版腔內減重手術風險程度可以接受到哪種程度?如果一年時達到30%-40% EWL又如何?
  
  評估可接受之過量體重減輕百分比(%EWL)的利益問題包括:
  * 胃繞道手術之後體重復胖者進行內視鏡吻合處-復位手術,一年之後,怎樣的%EWL被視為達到好的結果?
  * 初版內視鏡減重手術一年之後,怎樣的%EWL被視為達到好的結果?
  
  當病患利益相對低時(10%–20% EWL),對於82%的初版和77%的修正版手術,多數受訪者選擇的風險耐受相似於治療式內視鏡手術者(即三種最低風險的類別) 。
  
  當病患利益較高時(30%–40% EWL),47%的受訪者可接受的風險相當於初版腹腔鏡可調式胃束帶手術,35%可接受這種程度的修正版手術風險(P= .04);對於相當於Roux-en-Y 胃繞道手術的風險,僅7%的受訪者可以接受初版手術,但是有22%的受訪者可接受修正版手術(P= .0002)。
  
  Brethauer醫師解釋,接受過繞道手術後復胖的病患進行修正版手術,現在,復胖的唯一選擇是另一種手術,所謂的修正版手術,這有很高的風險;我認為人們願意接受較高風險的修正版內視鏡手術,因為替代方法不一定好。
  
  對於初版和修正版手術的可接受%EWL結果顯著不同:62%的受訪者認為,對於修正版手術,10%-30% EWL是好的結果,但是對於初版手術,只有34%認為這樣的程度是好的(對於 %EWL >30%, P< .0001);Brethauer醫師表示,我們知道人們對於修正版手術,願意接受較低的減重程度;依照我們的經驗,當有些人因為不適當的手術而復胖時,很難有後續的減重。
  
  這項調查也發現,認為初版腔內減重手術只可以進行符合目前國家健康研究中心(NIH)規範的有23%、身體質量指數(BMI) >30 kg/m2 者有27%、高風險者為22%;只有18%的受訪者偏好對BMI 值30 kg/m2 -35 kg/m2 的病患進行手術(剩下的10% 選擇其他);受訪者大部分的考量是腔內減重手術未證實的效果以及效果持續期間;68%同意在用於病患之前,需證明新手術有效果。
  
  Medscape General Surgery與會議主持人、紐約大學醫學院減重計畫醫療主任、外科助理教授Marina S. Kurian醫師討論此一調查,Kurian醫師表示,這特殊手術與特殊領域有許多人感到興趣,減重學會試著瞭解哪些人會進行、人們的期望為何、以及人們尋找的又是什麼。
  
  Kurian醫師表示,這是所有減重外科要進行的更大型手術,或者是胃腸科醫師要做的?我認為,下一步是探討不同醫師的實際成功率,以釐清手術的效益。
  
  她認為,腔內手術應屬於減重外科的領域,因為我們可以追蹤;我們提供飲食和營養諮商給病患,這是我們對病患可以實際控制的結果;追蹤相當重要,我們需要對我們的手術負責,我們的確必須檢視結果如何,但是病患本身需要對我們負責。
  
  Brethauer醫師接受Ethicon Endo-Surgery, Bard Davol與Tyco US Surgical 公司之資金或研究贊助 。Kurian 醫師接受Inamed/Allergan之獎助金、資金、教研補助。
  
  美國代謝與減重外科學會(ASMBS)第25屆年會:摘要 PL-44。發表於2008年6月20日。
  
  
  

Survey Assesses Bariatric Surgeons' Expectations and Risk Tolerance for Endoluminal Procedures

By Jacquelyn K. Beals, PhD
Medscape Medical News

June 23, 2008 (Washington, DC) — Bariatric surgeons might be willing to accept less weight loss and more risk in revisional than in primary endoluminal procedures, according to a survey distributed here at the American Society for Metabolic & Bariatric Surgery (ASMBS) 25th Annual Meeting. The results indicate the levels of weight loss and risk considered acceptable for currently developing bariatric endoluminal procedures.

The questionnaire was developed by the ASMBS Emerging Technologies Committee and was distributed to society members; 16% were completed and returned (n?= 214). Risk was assessed for 5 common procedures: diagnostic endoscopy (considered low risk), endoscopic polypectomy, endoscopic retrograde cholangiopancreatography, laparoscopic adjustable gastric banding, and laparoscopic Roux-en-Y gastric bypass (considered high risk).

"In general, I think concern about the risk of these [endoluminal] procedures is pretty low," said presenter Stacy A. Brethauer, MD, from the section of advanced laparoscopic and bariatric surgery in the department of general surgery at the Cleveland Clinic, in Ohio, who spoke with Medscape General Surgery. "So we did assess risk, but mainly to compare what people would tolerate in terms of the risk–benefit ratio for the primary and revisional procedures."

Survey questions about risk included:

  • What level of risk would you be willing to accept for a revisional endoluminal procedure that achieves 10% to 20% excess weight loss (EWL) at 1 year? What about 30% to 40% EWL at 1 year?
  • What level of risk would you be willing to accept for a primary endoluminal bariatric procedure that achieves 10% to 20% EWL at 1 year? What about 30% to 40% EWL at 1 year?

Benefit questions assessed the percent excess weight loss (%EWL) that would be acceptable:

  • What %EWL would you accept as a good outcome 1 year after an endoscopic anastomotic-reduction procedure for weight regain after gastric bypass?
  • What %EWL would you accept as a good outcome 1 year after a primary endoscopic bariatric procedure?

When patient benefit was relatively low (10%–20% EWL), the majority of respondents selected a risk tolerance similar to that for a therapeutic endoscopic procedure (i.e., the 3 lowest risk categories) for primary (82%) and revisional (77%) procedures.

When patient benefits were higher (30%–40% EWL), 47% of respondents were willing to accept a risk equivalent to laparoscopic adjustable gastric banding for primary procedures, and 35% of were willing to accept this degree of risk for revisional procedures (P?= .04). Risk equivalent to Roux-en-Y gastric bypass was acceptable to only 7% of respondents for primary procedures but to 22% of respondents for revisional procedures (P?= .0002).

"Revisional procedures are performed on patients who have already had a gastric bypass and have weight regain.... Right now, the only alternative for weight regain is another surgery, a revisional surgery, which carries a very high risk," explained Dr. Brethauer. "I think people were willing to accept a higher degree of risk for the revisional endoscopic procedures because the alternative is not good."

Acceptable %EWL outcomes differed significantly for primary and revisional procedures: 62% of respondents considered 10% to 30% EWL a good outcome for revisional procedures, but only 34% found this a good outcome for primary procedures (P?< .0001 for %EWL >30%). "We know that people are willing to accept lower weight loss for the revisional procedures; in our experience, it's hard to induce further weight loss when somebody's had weight regain without being fairly invasive," said Dr. Brethauer.

The survey also determined that primary endoluminal bariatric procedures should be performed only on patients who meet current National Institutes of Health (NIH) criteria (23%), those with a body mass index (BMI) >30?kg/m2 (27%), or those at high risk (22%). Only 18% of respondents favored the procedures for patients with a BMI of 30?kg/m2 to 35?kg/m2 (the remaining 10% checked "other"). The greatest concerns of respondents were the unproven efficacy and durability of endoluminal bariatric procedures; 68% agreed that "the effectiveness of a new procedure needs to be proven before...using it on patients."

Medscape General Surgery discussed the survey with session moderator Marina S. Kurian, MD, FACS, assistant professor of surgery, and medical director of the program for surgical weight loss at New York University School of Medicine, in New York. "With this particular procedure and particular area being so interesting to so many different people..., the Bariatric Society is truly trying to measure who is doing it, what people are expecting, and what people are finding," said Dr. Kurian.

"Is this something that's going to become a bigger procedure for all bariatric surgeons to do, or for gastroenterologists to do?" Dr. Kurian asked. "I think the next step is to find out what the actual success rate is among the different surgeons to clearly validate the procedure."

She feels that the endoluminal procedure should stay in the realm of bariatric surgeons "because we have a follow-up. We provide dietary and nutritional counseling for the patients, and that's how we can really control what the outcomes are for our patients. The follow-up is incredibly important.... We need to be accountable for our procedures, we obviously have to...check what our outcomes are. But the patients themselves need to be accountable to us," Dr. Kurian said.

Dr. Brethauer has received grant or research support from Ethicon Endo-Surgery, Bard Davol, and Tyco US Surgical corporations. Dr. Kurian has received honoraria, grant, teaching, and research support from Inamed/Allergan.

American Society for Metabolic & Bariatric Surgery 25th Annual Meeting: Abstract PL-44. Presented June 20, 2008.

    
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