Interventional procedure consultation document

Laparoscopic gastric plication for the treatment of severe obesity

Treating severe obesity by stitching folds in the stomach to make it smaller using keyhole surgery

Laparoscopic gastric plication reduces the size of the stomach to limit food intake. It is carried out using keyhole surgery through several (usually five or six) small cuts in the abdomen (belly). It involves folding the stomach in on itself and stitching it together to reduce its volume by about 70%. None of the stomach is removed and the procedure is potentially reversible.

The National Institute for Health and Clinical Excellence (NICE) is examining laparoscopic gastric plication for the treatment of severe obesity and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic gastric plication for the treatment of severe obesity.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 22 May 2012

Target date for publication of guidance: 25 August 2012

1   Provisional recommendations

1.1   The evidence on laparoscopic gastric plication for severe obesity raises no major safety concerns in the short term. There is inadequate evidence about safety in the long term, specifically with regard to the reversibility of the procedure and how it affects the safety of any further gastric surgery that may be necessary. There is limited evidence of efficacy in the short and medium term but  more evidence is needed about the long-term efficacy of the procedure. Therefore, laparoscopic gastric plication for the treatment of severe obesity should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake laparoscopic gastric plication for the treatment of severe obesity should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainties about the procedure’s long-term efficacy and about how the procedure may affect the safety of any further gastric surgery that they may need. Clinicians should provide patients with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/guidance/IPGXXX/publicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients having laparoscopic gastric plication for severe obesity (see section 3.1).

1.3   Laparoscopic gastric plication for severe obesity should only be carried out in units specialising in bariatric surgery that can offer the procedure as one of a range of treatment options.

1.4   NICE encourages further research and data collection on laparoscopic gastric plication for severe obesity, which should include information about long-term efficacy and safety, and specifically how the procedure influences further gastric surgery. Comparison with alternative procedures would be useful.

 

2   The procedure

2.1   Indications and current treatments

2.1.1   Severe obesity is defined as a body mass index (BMI) of 40 kg/m² or more, or between 35 kg/m² and 40 kg/m² in association with significant comorbidities such as hypertension or diabetes. Weight loss reduces the risk of comorbidities worsening and improves long-term survival.

2.1.2   Severe obesity is managed by dietary advice, exercise, lifestyle changes and medication. Bariatric surgery is considered as a treatment option in selected patients who have not lost enough weight using these measures.

2.1.3   Surgical procedures for severe obesity aim to enable the patient to reduce their weight and to maintain weight loss by restricting the size of the stomach and/or by decreasing the capacity to absorb food. Procedures that reduce the size of the stomach (gastric volume) limit the capacity for food intake by producing a feeling of satiety with a smaller ingested volume of food. They include laparoscopic gastric banding and sleeve gastrectomy. Procedures aimed at decreasing the capacity to absorb food include biliopancreatic diversion and duodenal switch. A patient may have more than one procedure at the same time. Patients are also advised to modify their eating behaviour by adhering to an explicit postoperative diet.

 

2.2   Outline of the procedure

2.2.1   Laparoscopic gastric plication aims to help patients’ lose weight by reducing the size of the stomach. It is usually done by plicating the greater curve of the stomach, although anterior plication has also been reported. Because none of the stomach is removed, it is potentially a reversible procedure.

2.2.2   The procedure is done with the patient under general anaesthesia, using several (usually 5 or 6) small incisions in the abdomen for the placement of a camera and ports for instruments. Greater curvature plication involves freeing the greater curve of the stomach by dissecting it from the greater omentum and short gastric vessels. Plication is done by folding the gastric wall inward along the greater curvature and securing this fold using rows of running sutures. Modifications of the technique may include a double or triple plication of the greater curve, and this may need extra rows of sutures.

2.2.3   Patients are placed on a postoperative diet that typically involves progression from fluids to semi-solid foods, avoiding intake of solid foods for approximately 6 weeks.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP/988/overview

 

2.3   Efficacy

2.3.1   A case series of 135 patients reported mean excess weight-loss of 65% at a mean follow-up of 23 months (the number of patients followed up was not given). The study reported a significantly higher mean excess weight-loss of 70% for patients with a BMI of < 45 kg/m² (110/135) compared with 56% for patients with a BMI of > 45 kg/m² (25/135) (p = 0.006). A case series of 100 patients reported mean excess weight-loss of 54% after 6 months and 60% after 24 months (72 and 50 patients respectively).

2.3.2   The case series of 135 patients reported inadequate excess weight-loss (defined as excess weight loss < 50%) in 21% (29/135) of patients and failure of the procedure (defined as excess weight loss < 30%) in 6% (8/135) of patients at a mean follow-up of 23 months.

2.3.3   A case series of 42 patients who had excess weight-loss of 20% at 1 month follow-up reported no regaining of weight at 18-month follow-up.

2.3.4   In the case series of 100 patients, 38 patients had comorbidities such as hypertension, diabetes, low back pain and sleep apnoea. Improvements were reported for 71% (15/21) of patients with low back pain, 61% (8/13) of patients with diabetes, 67% (6/9) of patients with hypertension, and 100% (3/3) of patients with sleep apnoea, 6 months after the operation.

2.3.5   A case series of 15 patients reported a significant improvement in the overall quality of life score (IWQOL [impact of weight on quality of life]-Lite; range 0–100, higher score indicating better quality of life) in 6 patients after greater curvature plication (p = 0.009) but not in 9 patients treated by anterior gastric plication (p = 0.38) at 12-month follow-up (numerical scores not reported).

2.3.6   The Specialist Advisers listed additional key efficacy outcomes as excess weight-loss at 3, 5 and 10 years and durability of plication as assessed by endoscopic evaluation or Gastrografin swallow at 12 months.

 

2.4   Safety

2.4.1   Partial jejunal necrosis due to portomesenteric thrombosis was reported in 1 patient in the case series of 135 patients 24 days after the procedure. This was treated by small bowel resection at laparotomy.

2.4.2   Gastric perforation in the prepyloric area was reported in 1 patient in the case series of 100 patients 3 days after the procedure (repaired at laparotomy).

2.4.3   Gastric obstruction due to herniation of the ‘gastric fundus between 2 distal fasteners of the suture line’ was reported in 1 patient in the case series of 135 patients 14 months after the procedure. This was treated by surgical reduction of the herniated fundus and reinforcement of the suture line using a laparoscopic approach.

2.4.4   Gastric leak at the suture line was reported in 2 patients in the case series of 135 patients (timing not stated). The patients were readmitted 7 days after the procedure and were treated conservatively. Gastric leak with pain secondary to forceful vomiting was reported in 1 patient in a case series of 100 patients 2 days after the procedure. This was treated by repairing the suture line and assessing the plication.

2.4.5   Intracapsular liver haematoma with abscess was reported in 1 patient in the case series of 100 patients 6 months after the procedure. This was treated by drainage of the abscess using a laparoscopic approach.

2.4.6   Intragastric seroma which resulted in gastric obstruction was reported in 2 patients in the case series of 135 patients 3 months after the procedure. This was treated by revision of plication.

2.4.7  Gastrointestinal bleeding was reported in 2 patients in the case series of 135 patients: the patients were readmitted 5 and 30 days after the procedure and were treated conservatively.

2.4.8   Non-obstructive jaundice was reported in 2 patients in the case series of 100 patients for more than 2 weeks after the procedure; it ‘disappeared spontaneously’.

2.4.9   Hypocalcaemia was reported in 1 patient in the case series of 100 patients (no further details reported).

2.4.10   Prolonged nausea and vomiting (attributed to mucosal oedema caused by venous stasis) was reported for 2–20 days in ‘most’ of the 93 patients treated with single plication but only for ‘a few hours’ in 42 patients treated with multiple plication (exact figures not reported) in the case series of 135 patients who had laparoscopic greater curvature plication.

2.4.1   ‘Permanent’ vomiting and discomfort due to adhesions between liver and stomach was reported in 1 patient in the case series of 100 patients: this resolved after an operation to separate the adhesions 8 months after the procedure.

2.4.12   The Specialist Advisers listed an anecdotal event as disruption of plication due to ‘broken suture causing weight regain’. They listed theoretical events as bleeding during dissection of omentum from the greater curvature of the stomach, peritonitis, injury to spleen, ischaemia or infarction of the plicated stomach and dysphagia.

 

3   Further information

3.1   This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing audit support (which is for use at local discretion), which will be available when the guidance is published.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

March 2012

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

_{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}