Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503269
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2007-07-16
Brief Title:
Local Anaesthetic Day-care Haemorrhoidectomy Challenges Traditional Concepts - a Randomised Controlled Trial
Sponsor:
East Kent Hospitals University NHS Foundation Trust
Organization:
East Kent Hospitals University NHS Foundation Trust
Study Overview
Official Title:
Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Local anaesthetic day-care open haemorrhoidectomy LH is feasible cheap and may be the cost-effective surgical approach to third degree haemorrhoids This prospective randomised controlled trial compares patients evaluation of LH with general anaesthetic day-care Parks modified Milligan-Morgan haemorrhoidectomy GH
Methods 41 patients with third degree haemorrhoids were randomised to LH 19 cases and GH 22 cases Demographics were comparable Independent assessment by a research nurse and clinical evaluation ran parallel for 6 months Outcome measures were average and expected pain scores for 10 days satisfaction scores at 10 days 6 weeks and 6 months Secondary outcomes were journey time and cost in day surgery
Methods 41 patients with third degree haemorrhoids were randomised to LH 19 cases and GH 22 cases Demographics were comparable Independent assessment by a research nurse and clinical evaluation ran parallel for 6 months Outcome measures were average and expected pain scores for 10 days satisfaction scores at 10 days 6 weeks and 6 months Secondary outcomes were journey time and cost in day surgery
Detailed Description:
INTRODUCTION
Open haemorrhoidectomy is a commonly performed painful operation In 1998-99 26514 haemorrhoidectomies were performed in the UK of which 14373 were day cases A further 5342 could have been performed as day surgery1 Improvements in multimodal2 and pre-emptive analgesia3 introduction of stapled anopexy4 and improvements in patient counselling5 have led to increasing number of day surgical treatment of haemorrhoids Technique of LH is described6-11 but with the paucity of randomised controlled trials this is rarely offered as a routine choice to patients with third degree haemorrhoids
AIM
This randomised controlled trial compares patient-evaluation of postoperative pain and expected pain scores for 10 days and satisfaction scores at 10 days 6 weeks and 6 months between local and general anaesthetic day surgical open haemorrhoidectomy Clinical outcomes for 6 months cost comparison and evaluation of total journey time in day surgical unit formed part of the study
PATIENTS AND METHODS
This randomised controlled trial was approved by the Research and Development department and the Local Research Ethics committee We performed a pilot evaluation of ten-day average pain and expectation scores after LH in 7 patients Based on the data from this pilot study and the average pain scores from the literature for GH we calculated a requirement of 40 patients to give a 90 power to the study at the 5 significance level students t-test to detect a 22 difference in 10 day average pain scores with a standard deviation of 1712 Null hypothesis was that there was no difference in the pain scores between the two groups
Forty two patients with third degree haemorrhoids had full explanation of the trial verbal and written with copies sent to their GP and were randomised Figure 1 on the day of surgery after consent Patients unfit for day-surgery were excluded Computer generated random numbers with opaque envelopes produced by the principal researcher GNR were opened by the research nurse WH after obtaining the research consent
Verbal and written information of the expected postoperative course following open haemorrhoidectomy were given to all patients This leaflet detailed the measures to take in the event of constipation or difficulty in passing urine if such a problem arose They were given the research nurses contact number in the event of a problem and were advised to contact out-of-hours GP service or the research nurse
Research nurse WH assessed their pain and expectation scores in the post operative period on the day of surgery and spoke to all the patients on the day after surgery to record their comments and reinforce the importance of accurate scoring Patients then recorded their pain and expectation scores at home for 10 days This was the average of the pain that the patients experienced before during and after defecation or the average of the pain during the course of the day Two patients failed to return their 10 day pain scores 7
Pain scores were recorded on a ten-point Visual-analogue scale with scores from 1 to 10 with 1 being no pain and 10 being as bad as it could be Ten-point patient expectation score was -5 to 5 with -5 being much better than expected and 5 being much worse than expected Seven point satisfaction score was -3 to 3 with -3 being extremely dissatisfied and 3 being extremely satisfied
Clinical follow-up by the surgeon NGR at 10 days 6 weeks and 6 months evaluated the surgical outcome and recorded all surgical complications Patients sent their satisfaction scores directly to the research nurse at these time-points and were un-influenced by the surgical out-patient visit
All haemorrhoidectomies Parks modified Milligan-Morgan technique13 were performed by a single surgeon NGR Prone-Jacknife position with buttocks strapped apart was used for those randomised to local anaesthesia while Lithotomy-Trendelenburg position was used for those undergoing the procedure under general anaesthesia Those with Type B and C buttocks10 needed more Trendelenburg position
Perianal block was used for all patients irrespective of their randomisation GH were given the block prior to commencement of surgery This was performed with 20 ml of 1 Lignocaine with 1 in 10000 Adrenaline injected at four sites midline anterior and posterior left and right lateral fanning the needle in three directions at each of the four sites care being taken to inject outside the external sphincter to avoid pain Once the sphincter muscle relaxed with the perianal block a further 10 ml of the same anaesthetic was injected submucosally raising a bleb in each of sites corresponding to the sites of perianal block This bleb was massaged inferiorly No sedation was used with local anaesthetic haemorrhoidectomy
Following diathermy excision of haemorrhoids a tube of lignocaine gel Instillagel was instilled into the anal canal followed by insertion of a gram of metronidazole and 50 mg of voltarol unless a history of asthma contraindicated the use of Voltarol in which case that was omitted A soft sponge pack curisponge was subsequently inserted Patients were warned pre-operatively to expect the passage of the gelatinous curisponge in the post-operative period with their first defaecation
A package of medications was given to take home TTA TTA contained Co-codamol Ibuprofen Metronidazole Lactulose Dulcolax 5 lignocaine ointment and 2 Diltiazem cream with detailed instructions on its usage Message in the post-operative instruction leaflet was reiterated prior to discharge
Journey time was calculated as the time elapsed between the start of anaesthesia and patient going home
Infection was defined as presence of purulent discharge with heightened pain a visit to their general practitioner and use of antibiotics over and above the Metronidazole prescribed on discharge
Sum of the individual costs of the suture material anaesthesia cost of day surgery staff recovery room costs and post operative medications were the basis of cost analysis
Statistical analysis
Data collected on Microsoft Excel was analysed on Analyse-it for Microsoft Excel Analyse-it Software Ltd Leeds UK Chi-square test and Mann-Whitney U test were used Where the data was normally distributed as in the comparison of age students t-test was used Serial measurements on linear analogue pain score were summarised by calculating the average pain over the 10-day time period for each patient as a summary measure14
Open haemorrhoidectomy is a commonly performed painful operation In 1998-99 26514 haemorrhoidectomies were performed in the UK of which 14373 were day cases A further 5342 could have been performed as day surgery1 Improvements in multimodal2 and pre-emptive analgesia3 introduction of stapled anopexy4 and improvements in patient counselling5 have led to increasing number of day surgical treatment of haemorrhoids Technique of LH is described6-11 but with the paucity of randomised controlled trials this is rarely offered as a routine choice to patients with third degree haemorrhoids
AIM
This randomised controlled trial compares patient-evaluation of postoperative pain and expected pain scores for 10 days and satisfaction scores at 10 days 6 weeks and 6 months between local and general anaesthetic day surgical open haemorrhoidectomy Clinical outcomes for 6 months cost comparison and evaluation of total journey time in day surgical unit formed part of the study
PATIENTS AND METHODS
This randomised controlled trial was approved by the Research and Development department and the Local Research Ethics committee We performed a pilot evaluation of ten-day average pain and expectation scores after LH in 7 patients Based on the data from this pilot study and the average pain scores from the literature for GH we calculated a requirement of 40 patients to give a 90 power to the study at the 5 significance level students t-test to detect a 22 difference in 10 day average pain scores with a standard deviation of 1712 Null hypothesis was that there was no difference in the pain scores between the two groups
Forty two patients with third degree haemorrhoids had full explanation of the trial verbal and written with copies sent to their GP and were randomised Figure 1 on the day of surgery after consent Patients unfit for day-surgery were excluded Computer generated random numbers with opaque envelopes produced by the principal researcher GNR were opened by the research nurse WH after obtaining the research consent
Verbal and written information of the expected postoperative course following open haemorrhoidectomy were given to all patients This leaflet detailed the measures to take in the event of constipation or difficulty in passing urine if such a problem arose They were given the research nurses contact number in the event of a problem and were advised to contact out-of-hours GP service or the research nurse
Research nurse WH assessed their pain and expectation scores in the post operative period on the day of surgery and spoke to all the patients on the day after surgery to record their comments and reinforce the importance of accurate scoring Patients then recorded their pain and expectation scores at home for 10 days This was the average of the pain that the patients experienced before during and after defecation or the average of the pain during the course of the day Two patients failed to return their 10 day pain scores 7
Pain scores were recorded on a ten-point Visual-analogue scale with scores from 1 to 10 with 1 being no pain and 10 being as bad as it could be Ten-point patient expectation score was -5 to 5 with -5 being much better than expected and 5 being much worse than expected Seven point satisfaction score was -3 to 3 with -3 being extremely dissatisfied and 3 being extremely satisfied
Clinical follow-up by the surgeon NGR at 10 days 6 weeks and 6 months evaluated the surgical outcome and recorded all surgical complications Patients sent their satisfaction scores directly to the research nurse at these time-points and were un-influenced by the surgical out-patient visit
All haemorrhoidectomies Parks modified Milligan-Morgan technique13 were performed by a single surgeon NGR Prone-Jacknife position with buttocks strapped apart was used for those randomised to local anaesthesia while Lithotomy-Trendelenburg position was used for those undergoing the procedure under general anaesthesia Those with Type B and C buttocks10 needed more Trendelenburg position
Perianal block was used for all patients irrespective of their randomisation GH were given the block prior to commencement of surgery This was performed with 20 ml of 1 Lignocaine with 1 in 10000 Adrenaline injected at four sites midline anterior and posterior left and right lateral fanning the needle in three directions at each of the four sites care being taken to inject outside the external sphincter to avoid pain Once the sphincter muscle relaxed with the perianal block a further 10 ml of the same anaesthetic was injected submucosally raising a bleb in each of sites corresponding to the sites of perianal block This bleb was massaged inferiorly No sedation was used with local anaesthetic haemorrhoidectomy
Following diathermy excision of haemorrhoids a tube of lignocaine gel Instillagel was instilled into the anal canal followed by insertion of a gram of metronidazole and 50 mg of voltarol unless a history of asthma contraindicated the use of Voltarol in which case that was omitted A soft sponge pack curisponge was subsequently inserted Patients were warned pre-operatively to expect the passage of the gelatinous curisponge in the post-operative period with their first defaecation
A package of medications was given to take home TTA TTA contained Co-codamol Ibuprofen Metronidazole Lactulose Dulcolax 5 lignocaine ointment and 2 Diltiazem cream with detailed instructions on its usage Message in the post-operative instruction leaflet was reiterated prior to discharge
Journey time was calculated as the time elapsed between the start of anaesthesia and patient going home
Infection was defined as presence of purulent discharge with heightened pain a visit to their general practitioner and use of antibiotics over and above the Metronidazole prescribed on discharge
Sum of the individual costs of the suture material anaesthesia cost of day surgery staff recovery room costs and post operative medications were the basis of cost analysis
Statistical analysis
Data collected on Microsoft Excel was analysed on Analyse-it for Microsoft Excel Analyse-it Software Ltd Leeds UK Chi-square test and Mann-Whitney U test were used Where the data was normally distributed as in the comparison of age students t-test was used Serial measurements on linear analogue pain score were summarised by calculating the average pain over the 10-day time period for each patient as a summary measure14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None