ObeseNCT01950052
Pre-operative Diet: Effect of Wound Healing After Bariatric Surgery
A study testing Diet group 800 Kcal diet in people with Obese, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study is a randomised control trial comparing the effects of a pre-operative very low calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric surgery. The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obese
- What is being tested?
- Diet group 800 Kcal diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have given written informed consent
- Patients who are able to understand and comply with protocol requirements
- Patients 18-70 years old
- Patients scheduled for Laparoscopic Roux En Y Gastric Bypass
- Patients with BMI > 40 and < 60
Who cannot join
- Unable or unwilling to give an informed written consent
- Cognitive impairment or mental retardation
- Patient who do not understand or follow protocol requirements
- Severe hepatic impairment or portal hypertension
- Pregnancy and lactation
- Diabetes
Show all 14Show fewer
- Pre-existing chronic inflammatory disease
- Overt psychosis
- Porphyria
- Advanced renal disease
- Acute cerebrovascular or cardiovascular disease
- Patients with alcohol or drug addiction
- Patients taking medication known to impact wound healing (eg glucocorticosteroids, chemotherapy, immunosuppressant)
- Patients who lose less than 5% of body weight after 4 weeks of the diet
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: Randomised Controlled Trial to Study the Effects of Preoperative Very Low Calorie Diet on Wound Healing in Morbidly Obese Patients Undergoing Bariatric Surgery
This study is a randomised control trial comparing the effects of a pre-operative very low calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric surgery.
The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of shrinking the liver to make surgery easier. Studies have shown that after this diet the liver does shrink and therefore operating may be easier but this did not necessary translate into significant lesser operative times. The effects of operating during a catabolic phase have not been evaluated. Theoretically a low calorie diet before surgery is similar to starving a patient and can potentially create a state of malnutrition. This is rarely advisable before surgery and can lead to poor wound healing and poor healing of bowel anastomosis.
This study will ascertain if there is any difference in wound healing rates in these morbidly obese patients (BMI>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in groups who have taken the preoperative diet compared to those who were not on a special diet. Skin wounds will be evaluated. This will potentially reflect the general state of healing of the patient which includes the healing of bowel anastomosis. Surrogate markers will be employed to evaluate the pre-morbid nutritional state, effectiveness of dieting, subsequent wound healing (collagen production, markers for the different aspects of wound healing) and impact on liver cell death .This study will be able to tell us how safe this calorie deficient diet is in these morbidly obese patients before surgery.
Read the detailed description
Study Design:
Prospective single blinded randomised controlled study
Null hypothesis: There is no difference in wound healing between patients on a very low calorie diet and those not on a diet prior to a Laparoscopic Roux en Y gastric bypass (LRYGB)
Participants:
All patients referred to King's College Hospital for weight loss surgery who are morbidly obese (BMI>40) who undergo LRYGB will be eligible. All patients undergo an introductory group education session after which they are counselled one to one where the patient and the clinician decide on the most appropriate bariatric procedure. Only those who will undergo a laparoscopic roux en y gastric bypass will be offered the opportunity to participate in the study by a member of the research team. The study is open to all irrespective of age, sex, ethnicity and religion.
Written information will be given in the appropriate language.
Interventions:
Diet:
Patients who meet the eligibility criteria will be placed in 2 broad groups based on whether they smoke or not. In each group, patients will be randomly chosen in two subgroups:
Group I:taking the pre operative diet Group II:no special diet. A preoperative, low energy diet will be used for 4 weeks. The diet contains 3 pints of semiskimmed milk. This is equivalent to 1704 ml and provides a total intake of 800kcal, 82 g carbohydrate, 61 g protein and 30g fat in a day. Each patient will also take multivitamin and mineral supplementation. This will further be supplemented with a minimum of 2 litres of energy free liquids (water, diet fizzy drinks, mineral water, black tea / coffee or squash (no added sugar)) per day. The longterm safety and success of VLCD has been demonstrated.It does cause shrinkage of the liver and can decrease the patients weight prior to surgery.
Data collection:
Patient characteristics and medical history will be taken
Pre diet, post diet and prior to surgery:
- Anthropometric measurements: Height, Weight, BMI, Hip:Waist ratio
- Routine prediet blood tests and for routine preoperative evaluation: This includes full blood count,Lipid profile,Renal profile,Bone profile,Liver Function Tests
- Serum CK 18 (M30 and M65) levels before and after the diet, which is a marker of liver apoptosis.
- Imaging:
- Dual-energy X-ray absorptiometry (DEXA) scan - body composition (prediet,post diet and at 3 months)
- Ultrasound before and after the diet: The length and breadth of the liver will be measured, which will allow an estimate of the cross-section of the liver at a well defined constant point on each patient
- Two punch biopsies (4mm) from the abdominal wall where the patient is likely to have a laparoscopic port, before start of the diet
Per operatively:
- Elliptical excision of skin of the operating ports during the operation
- Operative difficulty score assessed by blinded surgeon and independent observer
Post operatively:
Follow up:
Patient will be followed at 1 week, 8 weeks, 3 months and then will continue to be followed according to our usual bariatric protocol.
Wound Healing Assessment:
- Examine all wounds and define presence of wound infection
- Two 4 mm punch biopsies of one of the healing wounds will be taken under local anaesthesia, at 7 days and 90 days postoperatively
- Conditions
- Obese
- Being tested
- Diet group 800 Kcal diet
- Keywords
- VLCD, Low calorie diet, very low calorie diet, pre-operative diet, liver shrinking diet, bariatric surgery, gastric bypass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet group 800 Kcal dietDietary supplement
Also called VLCD
Pre-operative liver shrinking diet of 800 kcal is administered for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No special diet, patients will continue with a normal diet |
| Diet group | Experimental | Pre-operative liver shrinking diet of 800 Kcal diet is administered for 4 weeks Receives: Dietary Supplement: Diet group 800 Kcal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen 1/3 ratio after diet and surgery
Special immunostains for collagen 1 and 3 will be utilised and their ratio will be calculated by an independent blinded operator
Measured: 7 days following surgery
Secondary outcomes (2)
Is there any difference in wound healing between patients undergoing aggressive calorie restriction and those without a dietary intervention prior to bariatric surgery?
Changes in elastin,fibrinogen,myofibroblasts and angiogenesis (formation of new blood vessels) will be evaluated using special immunostains
Measured: 7 days following surgery
Change in body composition between control group and patients with diet
DEXA scans will be performed for body composition analysis
Measured: At one moth after the diet and 3 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ameet G Patel, MS FRCS, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950052
- Sponsor's protocol ID
- KCH12-109
- Status last verified
- Feb 2016
- First submitted
- 18 Sep 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Study the Effects of Preoperative Very Low Calorie Diet on Wound Healing in Morbidly Obese Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01950052
- Acronym / sponsor ID
- KCH12-109
- Conditions
- Obese
- Keywords
- VLCD, Low calorie diet, very low calorie diet, pre-operative diet, liver shrinking diet, bariatric surgery, gastric bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomised control trial comparing the effects of a pre-operative very low calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric surgery.
The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of shrinking the liver to make surgery easier. Studies have shown that after this diet the liver does shrink and therefore operating may be easier but this did not necessary translate into significant lesser operative times. The effects of operating during a catabolic phase have not been evaluated. Theoretically a low calorie diet before surgery is similar to starving a patient and can potentially create a state of malnutrition. This is rarely advisable before surgery and can lead to poor wound healing and poor healing of bowel anastomosis.
This study will ascertain if there is any difference in wound healing rates in these morbidly obese patients (BMI>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in groups who have taken the preoperative diet compared to those who were not on a special diet. Skin wounds will be evaluated. This will potentially reflect the general state of healing of the patient which includes the healing of bowel anastomosis. Surrogate markers will be employed to evaluate the pre-morbid nutritional state, effectiveness of dieting, subsequent wound healing (collagen production, markers for the different aspects of wound healing) and impact on liver cell death .This study will be able to tell us how safe this calorie deficient diet is in these morbidly obese patients before surgery.
Detailed description
Study Design:
Prospective single blinded randomised controlled study
Null hypothesis: There is no difference in wound healing between patients on a very low calorie diet and those not on a diet prior to a Laparoscopic Roux en Y gastric bypass (LRYGB)
Participants:
All patients referred to King's College Hospital for weight loss surgery who are morbidly obese (BMI>40) who undergo LRYGB will be eligible. All patients undergo an introductory group education session after which they are counselled one to one where the patient and the clinician decide on the most appropriate bariatric procedure. Only those who will undergo a laparoscopic roux en y gastric bypass will be offered the opportunity to participate in the study by a member of the research team. The study is open to all irrespective of age, sex, ethnicity and religion.
Written information will be given in the appropriate language.
Interventions:
Diet:
Patients who meet the eligibility criteria will be placed in 2 broad groups based on whether they smoke or not. In each group, patients will be randomly chosen in two subgroups:
Group I:taking the pre operative diet Group II:no special diet. A preoperative, low energy diet will be used for 4 weeks. The diet contains 3 pints of semiskimmed milk. This is equivalent to 1704 ml and provides a total intake of 800kcal, 82 g carbohydrate, 61 g protein and 30g fat in a day. Each patient will also take multivitamin and mineral supplementation. This will further be supplemented with a minimum of 2 litres of energy free liquids (water, diet fizzy drinks, mineral water, black tea / coffee or squash (no added sugar)) per day. The longterm safety and success of VLCD has been demonstrated.It does cause shrinkage of the liver and can decrease the patients weight prior to surgery.
Data collection:
Patient characteristics and medical history will be taken
Pre diet, post diet and prior to surgery:
- Anthropometric measurements: Height, Weight, BMI, Hip:Waist ratio
- Routine prediet blood tests and for routine preoperative evaluation: This includes full blood count,Lipid profile,Renal profile,Bone profile,Liver Function Tests
- Serum CK 18 (M30 and M65) levels before and after the diet, which is a marker of liver apoptosis.
- Imaging:
- Dual-energy X-ray absorptiometry (DEXA) scan - body composition (prediet,post diet and at 3 months)
- Ultrasound before and after the diet: The length and breadth of the liver will be measured, which will allow an estimate of the cross-section of the liver at a well defined constant point on each patient
- Two punch biopsies (4mm) from the abdominal wall where the patient is likely to have a laparoscopic port, before start of the diet
Per operatively:
- Elliptical excision of skin of the operating ports during the operation
- Operative difficulty score assessed by blinded surgeon and independent observer
Post operatively:
Follow up:
Patient will be followed at 1 week, 8 weeks, 3 months and then will continue to be followed according to our usual bariatric protocol.
Wound Healing Assessment:
- Examine all wounds and define presence of wound infection
- Two 4 mm punch biopsies of one of the healing wounds will be taken under local anaesthesia, at 7 days and 90 days postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No special diet, patients will continue with a normal diet |
| Diet group | Experimental | Dietary Supplement: Diet group 800 Kcal dietPre-operative liver shrinking diet of 800 Kcal diet is administered for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have given written informed consent
- Patients who are able to understand and comply with protocol requirements
- Patients 18-70 years old
- Patients scheduled for Laparoscopic Roux En Y Gastric Bypass
- Patients with BMI > 40 and < 60
Key exclusion criteria (14 listed)
- Unable or unwilling to give an informed written consent
- Cognitive impairment or mental retardation
- Patient who do not understand or follow protocol requirements
- Severe hepatic impairment or portal hypertension
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet group 800 Kcal dietAlso: VLCDPre-operative liver shrinking diet of 800 kcal is administered for 4 weeks | Dietary supplement | Diet group |
Primary outcome
Collagen 1/3 ratio after diet and surgery
Time frame: 7 days following surgery
Special immunostains for collagen 1 and 3 will be utilised and their ratio will be calculated by an independent blinded operator
2 secondary outcomes
Is there any difference in wound healing between patients undergoing aggressive calorie restriction and those without a dietary intervention prior to bariatric surgery?
Time frame: 7 days following surgery
Change in body composition between control group and patients with diet
Time frame: At one moth after the diet and 3 months following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ameet G Patel, MS FRCS principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet group 800 Kcal diet in people with Obese, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen 1/3 ratio after diet and surgery (time frame: 7 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.