Laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss: Two RCTs

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A discussion in December included gastric bypass versus sleeve gastrectomy.

References: Peterli R, et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss patients with morbid obesity: the SM-BOSS randomized clinical trial. JAMA. 2018 Jan 16;319(3):255-265. doi:10.1001/jama.2017.20897

Salminen P, et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss at 5 years among patients with morbid obesity: the SLEEVEPASS randomized clinical trial. JAMA. 2018 Jan 16;319(3):241-254. doi:10.1001/jama.2017.20313

Summary: Published in the same issue of JAMA, these two trials – one in Switzerland, one in Finland – provide thorough insight into comparing the sleeve and gastric bypass for weight loss in morbidly obese patients. To be consice, the study designs, results, and conclusions are quoted below.

SM-BOSS trial – clinicaltrials.gov Identifier: NCT00356213

DESIGN, SETTING, AND PARTICIPANTS: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period.

RESULTS: Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, −7.18%; 95% CI, −14.30% to −0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass.

CONCLUSIONS AND RELEVANCE: Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery.

SLEEVEPASS trial – clinicaltrials.gov Identifier: NCT00793143

DESIGN, SETTING, AND PARTICIPANTS: The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015).

RESULTS: Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19).

CONCLUSIONS AND RELEVANCE: Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins.

Early versus delayed cholecystectomy

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A discussion in December compared early versus delayed cholecystectomy.

References: Ackerman J, et al. Beware of the interval cholecystectomy. The Journal of Trauma and Acute Care Surgery. 2017 Jul;83(10):55-60. Full-text for Emory users.

Gurusamy KS, Davidson C, Gludd C, Davidson BR. Early versus delayed laparoscopic cholecystectomy for people with acute cholecystitis (Review). Cochrane Database of Systematic Reviews. 2013 Jun 30;(6):CD005440. Full-text for Emory users.

Summary: Cochrane’s review on early vs delayed cholecystectomy included 6 trials and 488 individuals. Of those, 244 received laparoscopic cholecystectomy early (within 7 days of presentation), while the remaining 244 received it at least 6 weeks after index admission with acute cholecystitis. The primary conclusion is that “based on information from a varied number of participants as well as trials at high risk of bias, early laparoscopic cholecystectomy during acute cholecystitis appears safe and shortens the total hospital stay [by 4 days]” (p.2).

There was no significant difference in operating time. Only one of the trials measured time to return to work, nothing that patients in the early group returned to work an average of 11 days earlier than the delayed group. Four trials did not report any gallstone-related complications; one trial reported five, including two people with cholangitis. In five trials, one-sixth of people in the delayed group had either non-resolution or recurrence of symptoms before their planned operation and had to have emergency laparoscopic cholecystectomy (p.6).

Using the terms immediate and interval, Ackerman et al (2017) conducted a retrospective cohort analysis to quantify the morbidity and mortality associated with a delayed, or interval cholecystectomy (IC). Of all patients admitted to 7 hospitals within the same healthcare system, 337 had percutaneous cholecystostomy (PC), 177 (52.5%) of those also had an interval cholecystectomy (IC). The table below illustrates the outcomes:

ic outcomes

(Ackerman et al, 2017, p.57)

Simultaneous vs staged colorectal and hepatic resections

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One discussion this week involved the comparison of simultaneous and staged resections of colorectal cancer and synchronous colorectal liver metastases (SCRLM).

Reference: Reddy SK, et al. Simultaneous resections of colorectal cancer and synchronous liver metastases: a multi-institutional analysis. Annals of Surgical Oncology. 2007 Dec;14(12):3481-3491. doi:10.1245/s10434-007-9522-5

Summary: In a retrospective study of 610 patients at three institutions between 1985 and 2006, the authors compared postoperative morbidity and mortality after simultaneous and staged resections of colorectal cancer and SCRLM.

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Neoadjuvant chemotherapy for initially unresectable intrahepatic cholangiocarcinoma

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One discussion this week included using chemotherapy to enable initially unresectable intrahepatic cholangiocarcinoma (ICC) to be resectable.

Reference: Le Roy B, et al. Neoadjuvant chemotherapy for initially unresectable intrahepatic cholangiocarcinoma. The British Journal of Surgery. 2018 Jun;105(7):839-847. doi: 10.1002/bjs.10641

Summary: Surgical resection is the standard treatment for ICC, with a 5-year survival rate of 25-35% for those presenting with potentially resectable disease. Those with initially unresectable ICC are treated with chemotherapy alone and have a poor prognosis (p.839). The strategy of conversion to secondary resectability through chemotherapy regimens has resulted in good long-term survival for other tumors (colorectal liver and neuroendocrine liver metastases).  The authors state there is no published data on the use of neoadjuvant chemotherapy to achieve secondary resectability in locally advanced ICC.

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Small bowel obstruction: clinical and radiographic predictors for surgical intervention

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One discussion this week included the clinical and radiographic signs for operation or nonoperation in the setting of adhesive small bowel obstruction (ASBO).

Reference: Kulvatunyou N, et al. A multi-institution prospective observational study of small bowel obstruction: Clinical and computerized tomography predictors of which patients may require early surgery. The Journal of Trauma and Acute Care Surgery. 2015. 79(3);393-398. doi:10.1079/TA.0000000000000759.

Summary: The absence of flatus and the CT finding of free fluid and high-grade obstruction have been identified by Kulvatunyou et al (2015) as predictors that early operative intervention would be beneficial. This prospective observational study involved 200 patients at three academic and tertiary referral medical centers; 148 in the nonoperative group, 52 in the operative group.

Clinical signs: The only clinical sign identified as a predictor for surgical intervention, “no flatus” was listed in 58% of the operative group, 34% of the nonoperative group. Too large to include here, Table 3 in the text (p.397) lists the univariate analysis of all clinical signs.

CT findings: Individual CT signs listed include transition point, free fluid, multiple fluid locations, small bowel fecalization, mesenteric edema, closed loop, and high-grad obstruction. All had low PPVs, ranging 21-41%. Using the three predictors identified, the PPV improved but remained low at 37-56% (p.397).

The table below (p.397) illustrates the utility of the three variables in a few combinations.

predictors

In the article, the authors state that they are currently (2015) pursuing a study applying the predictors to a different ASBO patient population so as to cross-validate this predictor model. A search for such a study in the published literature was not successful.

Additional Reading: Catena F, et al. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2010 evidence-based guidelines of the World Society of Emergency Surgery. World Journal of Emergency Surgery. 2011 Jan 21;6:5. doi: 10.1186/1749-7922-6-5.

Lynch Syndrome: Surgical Management

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One discussion this week included the surgical management of lynch syndrome.

Reference: DynaMed Plus [Internet]. Ipswich (MA): EBSCO Information Services. 1995 – . Record No. 115317, Lynch syndrome – Surgery and procedures; [updated 2018 Sept 26, cited 2018 Nov 16];. Emory login required. (Click on link and search for “lynch syndrome”).

Summary: Surgery considerations for Lynch syndrome patients with colorectal cancer (DynaMed Plus, 2018):

  • full colectomy with ileorectal anastomosis recommended rather than segmental/partial colonic resection due to increased risk for metachronous cancers
  • National Comprehensive Cancer Network (NCCN) recommends considering segmental vs. extended colectomy for colorectal adenocarcinoma based on clinical scenario, individual considerations, and discussion of risk
  • European Society for Medical Oncology (ESMO) recommends discussing option of extended colectomy vs. intensive surveillance after standard surgery at time of colorectal cancer diagnosis, particularly in young patients
  • American College of Gastroenterology (ACG) recommends
    • colectomy with ileorectal anastomosis as preferred treatment option for Lynch syndrome patients with colon cancer or colonic neoplasia not controllable by endoscopy
    • segmental colectomy with regular surveillance after surgery as an option in patients not suitable for total colectomy
  • United States Multi-Society Task Force (USMSTF) on Colorectal Cancer recommends colectomy with ileorectal anastomosis for Lynch syndrome patients with colon cancer or colorectal neoplasia not removable by endoscopy
  • segmental colectomy may increase risk of metachronous colorectal cancer compared to extended colectomy in patients with Lynch syndrome
    • based on systematic review of observational studies
    • systematic review of 6 observational studies comparing segmental vs. extended colectomy in 871 patients with Lynch syndrome being treated for colorectal cancer
    • 705 patients (81%) had segmental colectomy and 166 patients (19%) had extended colectomy
    • mean follow-up 91 months
    • 161 patients (22.8%) receiving segmental colectomy and 10 patients (6%) receiving extended colectomy had metachronous colorectal cancer during mean follow-up of 91 months
    • compared to extended colectomy, segmental colectomy associated with increased metachronous colorectal cancer in analysis of 5 studies with 792 patients
      • odds ratio 4.02, 95% CI 2.01-8.04
      • NNH 3-18 with metachronous colorectal cancer in 6% of extended colectomy group
    • adverse events not reported

What is the operative management of diverticulitis?

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One discussion this week included the operative management of diverticulitis.

Reference: Nally DM and Kavanagh DO. Current controversies in the management of diverticulitis: a review. Digestive Surgery. 2018 Apr 19. doi:10.1159/000488216.

Summary: A treatment algorithm is illustrated below (Nally and Kavanagh, 2018, p.7).

fig2

Laparoscopic Lavage

Nally and Kavanagh highlight three RCTs comparing laparoscopic lavage and resection (Table 4, p.8): SCANDIV (2015), LOLA (2015), and DILALA (2016).  The main differences in the RCTs were the re-intervention rate, which varied according to when results were reports (prior to the time of expected stoma closure) or if stoma closure is specifically excluded. Surgical reinterventions accounted for a majority of adverse events.

table4

Surgical Resection

Originally a 3-stage operation, it was condensed into a 2-stage Harman’s procuedure in which the diseased segment was removed during initial laparotomy. This became the standard of care, yet the mortality rate is cited as 15% according to the SCANDIV study. Additionally, a Hartman’s procedure is limited by the morbidity and mortality of colostomy reversal or lifestyle implications of a permanent stoma for up to 60% of patients (p.8). A one-stage resection with restoration of continuity avoids some challenges but also creates concern about performing an anastomosis in a contaminated environment for a critically unwell patient.

A 2004 systematic review found an overall mortality rate of 9.9% for primary anastomosis  (n=568) and 18.8% for Hartman’s (n=1,051), with overall anastomotic leak rate for a primary anastomosis of 13.9% (p.8).

Elective Surgery for Diverticulitis

Approximately 15-30% of patients have recurrent episodes of diverticulities. Up to 30% have ongoing pain. There are 2 indications for elective surgery:

  1. Prophylaxis against recurrent attacks and complications
  2. Surgery for ongoing symptoms that impact quality of life.

Guidelines from the American Society of Surgeons of Colon and Rectal surgeons from 2000 recommended an elective resection after one or two episodes of acute uncomplicated diverticulitis (p.9). Currently, professional bodies included the AGA advise again routine resection and instead propose an individualized approach (p.9). Morbidity and mortality of elective procedures for diverticulitis can be significant.

Conversely, elective surgery to improve quality of life is coming more to the fore (p.9). A systematic review of 21 studies and more than 1,800 patients and an RCT – the DIRECT trial – with 109 patients seem to provide evidence in favor of resection. It must be noted that the RCT was terminated early.

Nally and Kavanagh (2018) conclude that diverticulitis is a common yet challenging topic that demands clinicians to provide an individualized yet evidence-based approach (p.1).