Impacto del handover sobre la aplicación de VoIP

During initial enrolment onto the trial, patients presenting with GORD were interviewed by an experienced Consultant Surgeon (RA or CJS), both of whom had extensive operative experience of performing all four variants of fundoplication. Questions were asked using a standard, structured questionnaire. Subsequent clinical appointments were undertaken by an experienced clinician (RA or CJS) at 1, 3, 6 and 12 months after the procedure using the same questionnaire format. At each visit, it was determined whether the individual was still convalescent or had returned to full activity. The presence or absence of a detailed list of symptoms was sought. Patients ranked the outcome of surgery on a modified Visick grading (Table 2.3.1), and were asked to score the outcome ranging from excellent to poor.

Table 2.3.1: Modified Visick grading

1 No symptoms

2 Mild symptoms easily controlled by simple measures such as avoiding certain

foods or small meals etc.

3 Moderate symptoms not controlled by simple measures but not interfering with

social or economic life

4 Moderate symptoms interfering with social or economic life

5 Symptoms as bad or worse than before operation

Stationary oesophageal manometry including response to several swallows of water and ambulatory pH monitoring was undertaken prior to operative intervention, and approximately 3 months post-procedure. A standardised procedure was closely followed; patients were fasted for 6 hours prior to the pH and manometry studies. A single use antimony crystal probe (Mediplus, High Wycombe, UK) was positioned 5cm above the lower oesophageal sphincter and connected to a FlexilogTM 2000

datalogger (Oakfield Instruments, Whitney, UK) [86]. The total number of reflux episodes and the percentage of time the pH was less then 4 recorded.

Prior to manometry being performed, all individuals were asked to cease medication known to affect oesophageal motility for 48 hours prior to the test. An eight lumen water-perfused catheter was used in 4 of the lumens placed concentrically at the region of the sphincter and amplified signals recorded using a PhoenixTM recording system (Albyn Medical, Dingwall, UK). The location and resting pressure of the lower oesophageal sphincter (or high pressure zone post-fundoplication) was located by the station pull through technique. Oesophageal wave amplitude and propagation were measured by ten 10 ml water bolus swallowing 30 seconds apart.

For the intra-operative manometry study, after establishing anaesthesia, an eight- lumen water perfused catheter (Oakfield Instruments Limited, Oxford, England) was placed into the oesophagus of the patient via the nose. The catheter was attached to a flexiolog 3000 datalogger (Oakfield Instruments Limited, Oxford, England) that in turn was connected to a portable pneumohydrolic pump (Oakfield Instruments Limited, Oxford, England). Gastric pressure, the location and resting pressure of the lower oesophageal sphincter (or high pressure zone post-fundoplication) and oesophageal body pressure was obtained using the station pull through technique. Manometry readings were then undertaken at pre-determined intervals i.e. post- anaesthethetic with no pneumoperitoneum, post-anaesthetic with pneumoperitoneum, post-fundoplication with pneumoperitoneum and post- fundoplication with no pneumoperitoneum

Laparoscopic anterior and posterior fundoplications were carried out as described previously [87, 88]. After introduction of the laparoscope, a brief inspection was performed to identify any hiatus hernia or the presence of adhesions; these were then subsequently graded. Intra-operative problems and the requirement to convert to open surgery were then noted. A standardised procedure was followed and any reason for variation was documented.

Operative procedures were undertaken by one of two experienced Upper GI Consultant Surgeons (RA and CJS). The operation began with dissection of the hiatal pillars, followed by full oesophageal mobilisation and posterior hiatal repair using a median of 2 nylon sutures. A tape was placed around the oesophagus to assist with oesophageal retraction and the short gastric vessels were not divided. In the anterior fundoplication, the fundus of the stomach was brought across the front of the lower oesophagus and was sutured to the right side of the oesophagus using 2 nylon sutures and then to the right crus with a further 2 nylon sutures. If necessary, the fundus was sutured to the apex of the crura. In the posterior fundoplication, the fundus of the stomach was wrapped behind the lower oesophagus and was again anchored to the right side of the oesophagus and the right crus.

Laparoscopic Nissen and Lind fundoplications were performed as described previously [89] by one of two experienced Consultant Upper Gastro-Intestinal Surgeons (RA and CJS). After introduction of the laparoscope, a brief inspection was performed to identify any hiatus hernia or the presence of adhesions; these were then subsequently graded. Intra-operative problems and the requirement to convert

to open surgery were then noted. A standardised procedure was followed and any reason for variation was documented.

Both procedures began with dissection of the hiatal pillars, followed by full oesophageal mobilisation and posterior hiatal repair. A tape was placed around the oesophagus to assist with oesophageal retraction and the short gastric vessels were not divided. In the Nissen fundoplication, a bougie was used in all cases, with the size used depending on the observed diameter of the oesophagus. Then the posterior fundus of the stomach was wrapped behind the lower oesophagus and the anterior fundus of the stomach was brought across the front of the lower oesophagus and 3 sutures were placed fundus to fundus (one suture incorporating the oesophagus).

In the Lind fundoplication, no bougie was used. A similar operation to the Nissen was undertaken, however, a ‘bare’ area was left between the anterior and posterior fundal wraps resulting in a 270-300O wrap being formed using six sutures (3 on each side). The operation was given a difficulty grading of 1-10 (1=easy; 10=difficult). This was an analogue qualitative assessment, with a value of 1 correlating with an operation that was undertaken with no difficulty, and a value of 10 correlating with a near impossible operation with extensive adhesions. The length of post-operative hospital stay and symptoms at discharge were noted.