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Post-POEM GERD in Patients Undergoing Conventional Versus Oblique Fibers Sparing Posterior Myotomy for Achalasia Cardia

2020-01-20 11:44:31 | BioPortfolio

Summary

AIM

Post-POEM GERD in Patients undergoing Conventional versus Oblique fibers sparing Posterior Myotomy for Achalasia Cardia - Single Blind Randomized Clinical Study.

Outcomes

A. Primary Outcome :

Assessment of GERD - 1. Symptoms - GERD HRQL Questionnaire ( at 8 weeks post procedure) 2.Upper GI Endoscopy (at 8 weeks post procedure) 3.pH manometry (at 8 weeks post procedure)

1. Secondary Outcomes:

1. Total procedure time

2. Operative and post-operative complications

3. Clinical success with reference to improvement in Eckardt score (Assessed at pre procedure & 8 weeks).

4. Change in barium column height on timed barium oesophagogram (Assessed at pre procedure & 8 weeks).

5. Change in IRP pressure by Manometry ( Assessed at pre procedure & 8 weeks).

Description

Achalasia cardia patients admitted in Asian institute of gastroenterology for POEM procedure will undergo randomization in 1:1 ratio (after they meet the inclusion criteria)- Conventional Group and Oblique sling fiber sparing Group.

Conventional Group will be those who have undergone standard Posterior myotomy by cutting of circular muscle fibers in lower esophagus while in Oblique sling fiber sparing group; Posterior myotomy with cutting of circular muscle fibers but spring of sling fibers will be included.

Surgical Technique:

Patients placed on a clear liquid diet until 12 hours before the procedure. And kept NPO 12 hours before procedure. Prophylactic antibiotic - single dose of a Cefoperzone 0.5g + Sulbactam 0.5g, IV was given 30 minutes before mucosostomy.

An Upper GI endoscopy was first performed under light sedation with the patient placed in supine position. Gastroesophageal junction (GEJ) identified on endoscopy and esophageal residue, if any was cleared. Length of myotomy was around 6-8 cm from Gastroesophageal junction extending 2-3 cm into gastric cardia and site for mucosostomy was posterior (5 - 6 o clock position).

General anesthesia was given and was followed by endotracheal intubation with a cuffed endotracheal tube. Patient was placed on positive pressure ventilation.

Standard EGD endoscope (Olympus GIF HQ 190; Olympus Corp, Tokyo, Japan) was used for the procedure. A tapered tip transparent cap (DH- 28GR; Fujifilm, Tokyo, Japan) was fitted onto the distal end of the scope to facilitate submucosal dissection.

Approximately 10-15 cm proximal to the GEJ, the mucosa is injected with a mixture of by methylene blue, saline, and epinephrine to create a mucosal bleb using 23-gauge sclerotherapy needle. Subsequently a small (3-4 mm) mucosal incision was made using a needle knife, which was further enlarged up to 2 cm in length by an insulated tip knife (KD-611L; Olympus Corp).

The endoscope was inserted to create a submucosal tunnel with a combination of blunt dissection, carbon dioxide insufflation (UCR; Olympus Corp), hydro dissection and careful electrocautery.

In all the cases, low flow gas tube (MAJ 1742; Olympus Corp) attached to CO2 insufflator (UCR; Olympus Corp) was used. The triangular tip knife (KD-640L; Olympus Corp) with spray coagulation mode was used for submucosal dissection and myotomy. The settings on electrosurgical unit (VIO300D; ERBE, Tübingen, Germany) during dissection and myotomy were identical i.e., ENDO CUT Q at 50 W, effect 3.

The tunnel was extended past the GEJ, 2 -3 cm onto the gastric cardia. Intervening blood vessels or bleeding during dissection were managed by coagulation forceps (Coagrasper G, FD-412LR, Olympus, Japan) using soft coagulation mode (80W, effect 5).

Circular muscle only myotomy was performed in upper esophagus, taking care to preserve the longitudinal muscle layers. Two penetrating vessels are identified at the lower end of esophagus. Oblique sling fibers seen lateral to these vessels are preserved in Oblique fiber sparing group while full thickness myotomy was performed at the lower end of esophagus and cardia in conventional group.. Length of cardiac myotomy was fixed to 3 cm while that of esophageal was variable depending on randomization. Adequacy of the myotomy was established by smooth passage of endoscope through the GEJ and a retroflexed evaluation of the LES.

The mucosal incision was then closed from distal to proximal end using standard endoscopic clips (EZ Clip, HX-610-090L; Olympus Corp)

Study Design

Conditions

GERD

Intervention

PER ORAL ENDOSCOPY MYOTOMY

Location

Asian institute of Gastroenterology/AIG Hospitals
Hyderabad
Telangana
India
500082

Status

Recruiting

Source

Asian Institute of Gastroenterology, India

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-20T11:44:31-0500

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