Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia.

BACKGROUND: Pneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results. METHODS: In a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux. RESULTS: A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%. CONCLUSIONS: In this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).

Transvaginal specimen removal after laparoscopic distal pancreatic resection.

PURPOSE: Transvaginal specimen removal has been introduced 20 years ago but then abandoned. With the advent of transvaginal interventions following the introduction of natural orifice transluminal endoscopic surgery, renewed interest was generated for hybrid procedures with minimal access for the intervention and use of transvaginal (TV) specimen removal. We present the first such series after laparoscopic distal pancreatectomy. METHODS: In seven subsequent women (median age 48 years) with body and tail pancreatic tumors undergoing laparoscopic distal pancreatectomy, the new method of TV specimen removal was applied. The patients' data and the technical successes as well as intra- and postprocedural complications were recorded prospectively. The patients were followed after discharge for gynecological examination. RESULTS: Specimen removal consisting of the pancreas and spleen in five and the pancreas only in two cases was technically successful; no intraoperative complications were encountered. Postoperative complications consisted of one case of intra-abdominal hemorrhage and one case of pancreatic fistula, attributable to the resection and not to TV specimen removal. Gynecological follow-up was normal in all seven patients. CONCLUSIONS: The technique of TV specimen removal is feasible and safe also after laparoscopic distal pancreatectomy. It may help to further diminish the access trauma of laparoscopic pancreatic surgery.

Is the transvaginal route appropriate for intra-abdominal NOTES procedures? Experience and follow-up of 222 cases.

BACKGROUND: Since 2007, natural orifice transluminal endoscopic surgery (NOTES) has been applied in humans. We performed this prospective study to evaluate the transvaginal route in terms of risks, complication rate, and long-term side effects such as dyspareunia. METHODS: From June 2007 to September 2011, we performed 222 transvaginal hybrid NOTES procedures: 220 transvaginal cholecystectomies (TVC) and 2 transvaginal appendectomies (TVA). All patients were asked to present to our associated gynecologists within 1 week for an examination. After at least 3 months, the patients were interviewed using a standard questionnaire. RESULTS: All operations could be successfully performed in this technique except two cases, which were converted to conventional laparoscopic cholecystectomy. The only intraoperative complication was the puncture of the urine bladder. We observed two postoperative complications: one biliary fistula 3 days after TVC, and one abscess in the Douglas pouch 3 weeks after TVC. The gynecological examinations revealed no abnormalities. The interview (median postoperative time, 6 months) with a follow-up rate of 93 % revealed no pain in the pelvis, dyspareunia, or sexual dysfunction after TVC. CONCLUSIONS: The transvaginal route is appropriate for NOTES procedures; there is only a minor and acceptable rate of intra- and postoperative morbidity.

NOTES cholecystectomy: matched-pair analysis comparing the transvaginal hybrid and conventional laparoscopic techniques in a series of 216 patients.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is currently a very important topic for both gastroenterologists and surgeons. We have developed a technique of transvaginal hybrid NOTES cholecystectomy (TVC) that leaves no visible scar and is applicable to daily use. This technique is compared to the conventional laparoscopic cholecystectomy (CLC) in a matched-pair analysis. METHODS: From June 2007 until February 2009, 108 NOTES cholecystectomies were performed. For a matched-pair analysis we first selected a group of 192 female patients who had undergone CLC and who were operated on by the same group of surgeons in the same time period. Then 108 pairs who had TVC were matched according to the degree of inflammation of the gallbladder and age. We were able to contact 208 patients at least 3 months after surgery. Hence, the study analysis was performed with 100 complete pairs. RESULTS: All 200 cholecystectomies were performed successfully without conversion. The TVC procedure was significantly longer than CLC (52 vs. 35 min, p<0.001). There were no intraoperative complications in either group. There were no significant differences with respect to reoperations, wound infections, consumption of analgesic drugs, length of hospital stay, and sick leave. Seventy-five TVC and 73 CLC patients had sexual intercourse after the operation without any complaints. CONCLUSION: We present here the largest series of NOTES for cholecystectomy published to date and the first comparative study with the gold standard. The TVC technique is as successful as the CLC, it causes no more complications than CLC, especially with respect to the vaginal approach, it is more time-consuming to perform, but has an ideal cosmetic result, i.e., no visible scar.