[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655346":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":72,"studyPopulation":61,"armGroups":73,"interventions":86,"overallOfficials":99,"centralContacts":103,"locations":110,"responsibleParty":126,"collaborators":61,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":61,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":161,"whyStopped":61,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Minia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical success at 12 months","Proportion of participants with clinical success, defined as a total Eckardt symptom score of 3 or less and no retreatment for achalasia between the index procedure and the 12-month assessment. Retreatment includes pneumatic dilation, repeat or rescue myotomy by either modality, or surgical revision. The Eckardt symptom score is the sum of four component scores-dysphagia, regurgitation, retrosternal pain, and weight loss-with each component scored from 0 to 3; total scores range from 0 to 12, with higher scores indicating more severe symptoms. Participants who undergo retreatment or have an Eckardt symptom score greater than 3 at 12 months will be classified as treatment failures.","12 months after the index procedure",[14,18,22,26,29,32,35,39,42,46,50,54,57],{"measure":15,"description":16,"timeFrame":17},"Gastroesophageal reflux symptoms measured by the GERD-HRQL total score","Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire total score. The total score ranges from 0 to 50, with higher scores indicating worse reflux-related quality of life. The presence of troublesome reflux symptoms will also be reported according to the prespecified questionnaire or protocol definition.","3, 6, and 12 months after the index procedure",{"measure":19,"description":20,"timeFrame":21},"Erosive reflux esophagitis of Los Angeles grade B or worse","Proportion of participants with reflux esophagitis graded B, C, or D according to the Los Angeles classification on protocol-specified upper endoscopy. Endoscopic findings will be assessed by a masked assessor.","3 and 12 months after the index procedure",{"measure":23,"description":24,"timeFrame":25},"Pathological esophageal acid exposure on 24-hour pH-impedance monitoring","Proportion of participants with pathological esophageal acid exposure, defined as acid exposure time greater than 6% of the 24-hour recording with esophageal pH below 4. Monitoring will be performed off proton-pump inhibitor therapy, and results will be reported by a masked assessor.","3 months after the index procedure; repeated at 12 months for participants in the prespecified objective-reflux substudy or when clinically indicated",{"measure":27,"description":28,"timeFrame":17},"Eckardt symptom score and component scores","Total Eckardt symptom score and the four component scores for dysphagia, regurgitation, retrosternal pain, and weight loss. The total score ranges from 0 to 12, with higher scores indicating more severe symptoms. The total score and component scores will be analyzed as continuous measures.",{"measure":30,"description":31,"timeFrame":21},"Esophagogastric junction relaxation measured by integrated relaxation pressure","Median 4-second integrated relaxation pressure (IRP), measured in mmHg by high-resolution esophageal manometry and reported by a masked assessor. Lower IRP values indicate better esophagogastric junction relaxation.",{"measure":33,"description":34,"timeFrame":21},"Esophageal emptying measured by timed barium esophagram","Height of the retained barium column, measured in centimeters at 1, 2, and 5 minutes during a timed barium esophagram and reported by a masked radiologist. Lower retained-column heights indicate better esophageal emptying.",{"measure":36,"description":37,"timeFrame":38},"Technical success of the index procedure","Proportion of participants in whom the intended myotomy is completed without conversion to an alternative approach or abandonment of the allocated procedure.","During the index procedure on Day 0",{"measure":40,"description":41,"timeFrame":38},"Index-procedure duration","Duration of the index procedure, reported in minutes. For laparoscopic Heller myotomy with Dor fundoplication, duration will be measured from skin incision to skin closure. For peroral endoscopic myotomy, duration will be measured from scope insertion to scope removal.",{"measure":43,"description":44,"timeFrame":45},"Length of post-procedure hospital stay","Number of days from completion of the index procedure to discharge from the index hospitalization. The same prespecified discharge criteria will be applied in both treatment groups.","From the index procedure through discharge from the index hospitalization, assessed up to 30 days",{"measure":47,"description":48,"timeFrame":49},"Time to resumption of oral liquid intake","Time in hours from completion of the index procedure to the first tolerated oral liquid intake, using the common prespecified stepwise diet-advancement pathway.","From completion of the index procedure through 72 hours after the procedure",{"measure":51,"description":52,"timeFrame":53},"Adverse events according to the Clavien-Dindo classification","Number and severity of intra-procedural and post-procedural adverse events, graded from I to V according to the Clavien-Dindo classification of surgical complications. Adverse events of special interest include mucosal perforation or leak, bleeding requiring intervention, capnoperitoneum or capnomediastinum requiring decompression, aspiration pneumonia, and reintervention. Events will be summarized by type, severity, and timing.","From the index procedure through 30 days after the procedure",{"measure":55,"description":56,"timeFrame":53},"Endoscopic adverse events according to the AGREE classification","Number and severity of endoscopy-related adverse events graded according to the Adverse events in GastroIntestinal Endoscopy (AGREE) classification. Events will be summarized by type, severity, and timing relative to the index procedure.",{"measure":58,"description":59,"timeFrame":60},"Retreatment-free survival","Time from the index procedure to the first occurrence of clinical failure, defined as an Eckardt symptom score greater than 3, or any retreatment for achalasia. Retreatment includes pneumatic dilation, repeat or rescue myotomy by either modality, or surgical revision. Retreatment-free survival will be summarized using Kaplan-Meier estimates.","From the index procedure through 12 months after the procedure",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":61,"timePerspective":61,"maskingInfo":67},"RANDOMIZED","PARALLEL","Two-arm, parallel-group, 1:1 randomized non-inferiority trial with a pre-specified margin of 12.5 percentage points, stratified by achalasia subtype (Chicago Classification type I or II versus type III) and, if more than one centre participates, by centre.","TREATMENT",{"masking":68,"maskingDescription":69,"whoMasked":70},"SINGLE","Single (Outcomes Assessor)\u002F Masking of participants and operators is not feasible because one intervention is endoscopic and the other laparoscopic. Outcome assessors performing and reporting high-resolution manometry, upper endoscopy with esophagitis grading, timed barium esophagram and 24-hour pH-impedance, together with the trial statistician and the endpoint adjudication committee, are masked to allocation. Participant-reported instruments are collected by masked coordinators using standardized scripts. Any unmasking is documented with justification.",[71],"OUTCOMES_ASSESSOR","BACKGROUND AND RATIONALE Achalasia is a primary esophageal motility disorder characterized by failure of the lower esophageal sphincter to relax appropriately and by absent or abnormal esophageal body peristalsis. Diagnosis is established by high-resolution manometry (HRM) and classified by the Chicago Classification version 4.0 into type I (no contractility), type II (panesophageal pressurization in at least 20% of swallows) and type III (spastic), with an elevated integrated relaxation pressure (IRP) supporting the diagnosis after exclusion of mechanical obstruction.\n\nAll available treatments are palliative and aim to reduce esophagogastric junction (EGJ) resistance; none restores peristalsis. Laparoscopic Heller myotomy (LHM) with a partial fundoplication has been a durable surgical standard for two decades. Peroral endoscopic myotomy (POEM), introduced in 2010, achieves myotomy through a submucosal tunnel, avoids cutaneous incisions and permits a tailored longer myotomy, but includes no anti-reflux procedure and is associated with more frequent post-procedural gastroesophageal reflux disease (GERD). Randomized evidence indicates that POEM is non-inferior to LHM with partial fundoplication for clinical success at short- and medium-term follow-up, at the cost of more reflux. Questions persist about comparative durability, the burden and management of post-treatment reflux, the influence of achalasia subtype and resource use outside high-volume Western referral centers.\n\nTRIAL DESIGN This is a prospective, single-center (with provision for multicenter expansion), two-arm, parallel-group, randomized, assessor-blinded, non-inferiority trial with 1:1 allocation. Randomization uses a computer-generated sequence with random permuted blocks of varying size prepared by an independent statistician, stratified by achalasia subtype (Chicago type I\u002FII versus type III) and by center if more than one site participates. Allocation is concealed using a secure central web-based system, or sequentially numbered opaque sealed envelopes, accessed only after eligibility confirmation and written informed consent. Enrollment, sequence generation and assignment are performed by separate individuals.\n\nINTERVENTIONS Both interventions are performed under general anesthesia with endotracheal intubation. Each surgical operator must have performed at least 20 prior LHM procedures and each endoscopist at least 20 prior POEM procedures. Procedures are video-recorded where feasible for quality assurance and adjudication.\n\nPOEM: after a clear-liquid diet for 48 hours and an overnight fast, with on-table esophageal lavage and CO2 insufflation throughout, a longitudinal mucosal incision is made approximately 10 to 12 cm proximal to the EGJ after submucosal lift. A submucosal tunnel is dissected distally across the EGJ and 2 to 3 cm onto the gastric cardia, confirmed by landmarks and a retroflexion check. A selective circular-muscle or full-thickness myotomy (operator discretion, recorded) is performed from approximately 7 to 10 cm above the EGJ to 2 to 3 cm below it, giving a total myotomy length of approximately 8 to 12 cm, which may be lengthened for type III disease. The mucosal entry is closed with endoscopic clips or an equivalent device. No anti-reflux procedure is performed.\n\nLHM + Dor: a standard laparoscopic approach with 4 to 5 ports is used, with retraction of the left lobe of the liver and limited hiatal dissection preserving the posterior attachments. An anterior longitudinal myotomy of the circular and longitudinal muscle layers extends approximately 6 cm onto the distal esophagus and 2 to 3 cm onto the gastric cardia. Mucosal integrity is confirmed by intraoperative endoscopy and\u002For an air-leak submersion test. A Dor anterior (180 to 200 degrees) partial fundoplication is constructed over the exposed mucosa. Conversion to open surgery, if required for safety, is recorded as a protocol deviation, and the participant remains in the assigned arm for the intention-to-treat analysis.\n\nCommon peri-operative care is standardized across arms: a contrast study or endoscopic check before resuming oral intake where clinically indicated, a stepwise diet advanced by tolerance, and a shared enhanced-recovery pathway for analgesia, thromboprophylaxis and discharge criteria. Routine proton-pump inhibitor therapy at standard once-daily dose is offered to all participants for the first 8 weeks and continued thereafter on the basis of symptoms and objective reflux testing, applying identical decision rules in both arms. Calcium-channel blockers and nitrates are discouraged during follow-up.\n\nMASKING Masking of participants and operators is not feasible. Outcome assessors performing and reporting HRM, upper endoscopy (esophagitis grading), timed barium esophagram and pH-impedance, the trial statistician and the endpoint adjudication committee are masked to allocation. Participant-reported instruments are collected by masked coordinators using standardized scripts. Any unmasking is documented with justification.\n\nSAMPLE SIZE Assuming clinical success of 90% in both arms, a non-inferiority margin of 12.5 percentage points, one-sided alpha of 0.025 and 80% power, approximately 90 evaluable participants per arm are required. Inflating for 15% attrition or non-evaluability gives an enrollment target of 110 per arm, or 220 in total. A blinded review of the pooled clinical-success rate and attrition will be undertaken at the midpoint to confirm that design assumptions remain plausible; the margin and target will not be altered on the basis of unblinded effect estimates.\n\nSTATISTICAL ANALYSIS The primary estimand is the difference in clinical-success proportions (POEM minus LHM + Dor) at 12 months. The difference and its two-sided 95% confidence interval are estimated using the Miettinen-Nurminen method or a Wald interval with continuity adjustment. Non-inferiority is concluded if the lower bound of the 95% confidence interval lies above -12.5 percentage points. Non-inferiority must be supported in both the intention-to-treat and per-protocol populations. If non-inferiority is established, a pre-specified hierarchical test for superiority is performed at the two-sided 0.05 level. The primary analysis is adjusted for the stratification factor(s) using a generalized linear model with a binomial family.\n\nBinary secondary outcomes are compared by risk difference and relative risk with 95% confidence intervals and logistic regression adjusted for stratification factors. Repeated continuous outcomes are analyzed with mixed-effects models for repeated measures including fixed effects for arm, time, arm-by-time interaction, baseline value and stratification factors, with a random participant effect. Procedure duration, length of stay and time to oral intake are compared with t-tests or Mann-Whitney tests as appropriate. Retreatment-free survival is summarized by Kaplan-Meier curves and compared by log-rank test and Cox proportional-hazards regression. Adverse events are summarized descriptively by arm, severity grade and timing. A pre-specified exploratory subgroup analysis examines effect modification of the primary outcome by achalasia subtype through an arm-by-subtype interaction term and is interpreted as hypothesis-generating. Sensitivity analyses include a tipping-point\u002Fbest-worst-case analysis and multiple imputation under a missing-at-random assumption. A detailed statistical analysis plan is finalized and signed before database lock and unmasking.",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"Peroral endoscopic myotomy (POEM)","EXPERIMENTAL","Participants undergo peroral endoscopic myotomy under general anesthesia. No anti-reflux procedure is performed. Routine proton-pump inhibitor therapy at standard once-daily dose is offered for the first 8 weeks and continued thereafter on the basis of symptoms and objective reflux testing.",[79],"Procedure: Peroral endoscopic myotomy",{"label":81,"type":82,"description":83,"interventionNames":84},"Laparoscopic Heller myotomy with Dor fundoplication","ACTIVE_COMPARATOR","Participants undergo laparoscopic Heller myotomy with a Dor anterior partial fundoplication under general anesthesia. Routine proton-pump inhibitor therapy at standard once-daily dose is offered for the first 8 weeks and continued thereafter under identical decision rules to those applied in the experimental arm.",[85],"Procedure: Laparoscopic Heller myotomy with Dor fundoplication",[87,94],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"PROCEDURE","Peroral endoscopic myotomy","Under general anesthesia with endotracheal intubation and CO2 insufflation, after 48 hours of clear-liquid diet, an overnight fast and on-table esophageal lavage, a longitudinal mucosal incision is made approximately 10 to 12 cm proximal to the esophagogastric junction following submucosal lift. A submucosal tunnel is dissected distally across the junction and 2 to 3 cm onto the gastric cardia, confirmed by palisade vessels, junctional narrowing and a retroflexion check. A selective circular-muscle or full-thickness myotomy, recorded as performed, extends from approximately 7 to 10 cm above the junction to 2 to 3 cm below it, giving a total myotomy length of approximately 8 to 12 cm, and may be lengthened for type III spastic disease. The mucosal entry is closed with endoscopic clips or an equivalent closure device. Endoscopists must have performed at least 20 prior POEM procedures.",[75],[93],"POEM Endoscopic \u002Fmyotomy Submucosal tunneling \u002Fendoscopic myotomy",{"type":88,"name":81,"description":95,"armGroupLabels":96,"otherNames":97},"Under general anesthesia with endotracheal intubation, a standard laparoscopic approach with 4 to 5 ports is used, the left lobe of the liver retracted and the esophagogastric junction exposed with limited hiatal dissection preserving the posterior attachments. An anterior longitudinal myotomy of the circular and longitudinal muscle layers extends approximately 6 cm onto the distal esophagus and 2 to 3 cm onto the gastric cardia. Mucosal integrity is confirmed by intraoperative endoscopy and\u002For an air-leak submersion test. A Dor anterior partial fundoplication of 180 to 200 degrees is constructed over the exposed mucosa. Conversion to open surgery for safety is recorded as a protocol deviation, and the participant remains in the assigned arm for the intention-to-treat analysis. Surgeons must have performed at least 20 prior laparoscopic Heller myotomy procedures.",[81],[98],"LHM plus Dor \u002FLaparoscopic Heller cardiomyotomy\u002F Heller-Dor procedure",[100],{"name":101,"affiliation":5,"role":102},"Saleh K Saleh, MD","PRINCIPAL_INVESTIGATOR",[104],{"name":105,"role":106,"phone":107,"phoneExt":108,"email":109},"Saleh Khairy K Saleh, MD","CONTACT","01201765401","+2","salehkhairy@mu.edu.eg",[111],{"facility":112,"status":61,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University","Minya","Minya Governorate","61519","Egypt","EG",{"type":119,"coordinates":120},"Point",[121,122],30.75813,28.09193,{"lat":122,"lon":121},[125],{"name":101,"role":106,"phone":107,"phoneExt":108,"email":109},{"type":102,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"Saleh Khairy Saleh MD","Lecturer of General Surgery, Department of Surgery, Faculty of Medicine","100655346","poem-versus-laparoscopic-heller-myotomy-with-dor-fundoplication-for-esophageal-achalasia-100655346",false,"NCT07814027","POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia","Peroral Endoscopic Myotomy (POEM) Versus Laparoscopic Heller Cardiomyotomy With Dor Fundoplication for the Treatment of Oesophageal Achalasia: A Randomized Controlled Trial","POEM-HD","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* New diagnosis of primary achalasia confirmed by high-resolution manometry according to the Chicago Classification version 4.0 (elevated median integrated relaxation pressure with 100% failed peristalsis), of any subtype (I, II or III).\n* Eckardt symptom score of 4 or more at baseline.\n* Upper endoscopy excluding mechanical obstruction, malignancy and pseudoachalasia.\n* Treatment-naive with respect to definitive therapy (no prior Heller myotomy, prior POEM or prior pneumatic dilation). Prior botulinum-toxin injection is permitted if administered at least 6 months before enrollment.\n* Fit for general anesthesia (American Society of Anesthesiologists physical status I to III).\n* Able to provide written informed consent and to comply with the follow-up schedule.\n\nExclusion Criteria:\n\n* Prior esophageal or gastric surgery, prior myotomy (surgical or endoscopic), or prior pneumatic dilation.\n* Secondary (pseudo-) achalasia, suspected or confirmed esophagogastric malignancy, or eosinophilic esophagitis.\n* Sigmoid or end-stage megaesophagus (tortuous, dilated greater than 7 cm) considered unsuitable for myotomy.\n* Severe esophageal varices, significant coagulopathy, or therapy with anticoagulants that cannot be safely interrupted.\n* Significant cardiopulmonary disease precluding general anesthesia or capnoperitoneum \u002F capnomediastinum.\n* Pregnancy or breastfeeding.\n* Body mass index below 18.5 kg\u002Fm2 with severe malnutrition requiring prior nutritional optimization (may be re-screened after optimization).\n* Inability to provide informed consent or anticipated non-compliance with follow-up.","ALL","18 Years","75 Years",{"count":141,"type":142},220,"ESTIMATED","INTERVENTIONAL",[145],"NA","Achalasia is a disorder of the esophagus in which the muscular valve between the esophagus and the stomach fails to relax, and the body of the esophagus loses its normal coordinated squeezing movement. People with achalasia have difficulty swallowing both solids and liquids, bring up undigested food, may have chest pain, and often lose weight. None of the available treatments cures the disease; all of them work by reducing the resistance at the junction between the esophagus and the stomach so that food and liquid can pass more easily.\n\nTwo established treatments do this by cutting the muscle of the valve (a myotomy). Laparoscopic Heller myotomy with a Dor anterior partial fundoplication (LHM + Dor) is performed through small abdominal incisions and includes a wrap of the stomach designed to limit acid reflux afterwards. Peroral endoscopic myotomy (POEM) achieves the same muscle division from inside the esophagus through a tunnel created under the lining, with no skin incisions and no anti-reflux wrap. POEM allows a longer, tailored myotomy, which may be an advantage in the spastic (type III) form of the disease, but reflux after the procedure is more common because no wrap is performed.\n\nThis trial will randomly assign 220 adults with newly diagnosed, previously untreated achalasia, in equal numbers, to receive either POEM or LHM + Dor. Randomization will be stratified by achalasia subtype (Chicago Classification type I or II versus type III). The main question is whether POEM controls symptoms about as well as LHM + Dor, so the trial is designed as a non-inferiority study with a pre-specified margin of 12.5 percentage points.\n\nThe primary outcome is clinical success at 12 months, defined as an Eckardt symptom score of 3 or less without any further treatment for achalasia. Participants will be assessed before treatment and again at 30 days and at 3, 6 and 12 months. Assessments include the Eckardt symptom score, reflux symptoms and quality of life, upper endoscopy, high-resolution manometry, timed barium esophagram and, at 3 months, 24-hour pH-impedance testing to measure acid reflux objectively. Complications will be graded using the Clavien-Dindo classification for surgical events and the AGREE classification for endoscopic events.\n\nBecause one treatment is endoscopic and the other is laparoscopic, neither the participants nor the operators can be masked. To protect against biased outcome assessment, the investigators reporting manometry, endoscopy, barium studies and pH-impedance, the trial statistician and the endpoint adjudication committee will all be masked to treatment allocation.\n\nThe trial will be conducted at Minia University Hospital, Faculty of Medicine, Minia University, Minia, Egypt, with provision for expansion to additional tertiary centers under a common standard-operating-procedure manual.",[148,149,150],"Esophageal Achalasia","Esophageal Motility Disorders","Gastroesophageal Reflux",[89,152,153,154,155,156,157,158,159,160],"POEM","Heller myotomy","Dor fundoplication","Achalasia","Eckardt score","High-resolution manometry","Chicago Classification v4.0","Gastroesophageal reflux disease","Minimally invasive esophageal surgery","NOT_YET_RECRUITING","2026-09-08",{"date":164,"type":165},"2026-09-10","ACTUAL",{"date":167,"type":142},"2026-09-20",{"date":169,"type":142},"2028-12-20",{"name":5,"class":6},1]