HaemorrhoidsNCT01342991
Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy
A study testing Laser Haemorrhoidectomy in people with Haemorrhoids and Haemorrhoidectomy, run by Northern Lincolnshire and Goole Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a randomised trial to compare both the procedures and the difference in their immediate postoperative pain, recovery and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoids, Haemorrhoidectomy, Milligan-Morgan Haemorrhoidectomy
- What is being tested?
- Laser Haemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Nov 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are fit enough to undergo general anaesthesia
- Are between the age of 18 and 80 years
- Are able and willing to provide informed consent
- Show no preference to either operative procedure and agree to randomization
- No contra-indications to receiving laser treatment
Who cannot join
- Are not fit enough to undergo a general anaesthesia
- Are not over the age of 18 years
- Are unable or unwilling to provide informed consent
- Have stated their operation preference
- Have any contra-indication preventing them from receiving laser treatment
- Have a history of non-compliance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern Linconshire & Goole NHS Foundation trust
Goole, North Lincolnshire, DN14 6RX
About this study
Official title: Randomised Controlled Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy
This is a randomised trial to compare both the procedures and the difference in their immediate postoperative pain, recovery and quality of life.
Read the detailed description
Haemorrhoidectomy (excision of haemorrhoids) is the procedure of choice for grade 3 \& 4 symptomatic haemorrhoids. The standard technique in the UK (open Milligan-Morgan) is to excise the haemorrhoids under general anaesthetic (typically using electrocautery) leaving raw areas in anal canal. As a result, patients often experience significant post operative pain which can impact on patient function for weeks following surgery. This would be considered as the gold standard for the operative treatment for haemorrhoids. Due to the difficult post operative recovery of this procedure, alternative techniques for performing haemorrhoidectomy have been explored. One approach, which is gaining some popularity, is stapled haemorrhoidectomy [1]. In this technique, a circular stapling device is used to excise proximal mucosa in order to disconnect the haemorrhoidal blood supply and to pull up the haemorrhoidal mass. The edges of the excised mucosa are simultaneously closed with a row of staples. In a recent meta-analysis of 29 randomised controlled trials including 2056 patients, stapled haemorrhoidectomy was associated with reduced postoperative pain and reduction in return to activity by nearly 12 days in comparison to open haemorrhoidectomy [2]. Although postoperative complication rates were similar, stapled haemorrhoidectomy was associated with significantly more recurrences in the longer term (relative risk 2.29). The stapled haemorrhoidectomy technique has not gained universal acceptance. This may be related to the cost and availability of stapling devices in many centres.
Unlike specialized stapling devices, lasers are widely available in the operating theatre and are used in many operations to cauterise tissue. The resulting burn is superficial in comparison to electrocautery. Consequently, lasers have been used to perform open haemorrhoidectomy with the expectation of reducing post operative pain. However, randomised trials comparing the use of lasers versus cold scalpel for open haemorrhoidectomy have shown no significant differences in post operative pain [3]. Although, the laser appears to offer no advantage in open haemorrhoidal procedures, an alternative technique for laser haemorrhoidectomy has been developed by Peter Thompson from Laser Haemorrhoid Centre in Phoenix, Arizona. In this alternative technique, a laser is used to seal the raw mucosal edges after excision of the piles. In common with stapled haemorrhoidectomy, the mucosa is sealed closed rather than left open. Consequently, patients appear to experience markedly less post operative pain. The technique is also simple and quick with a shallow learning curve. Due to the speed and relative comfort of the procedure, patients may be routinely operated on using sedation and local anaesthetic, rather than full general anaesthetic which is standard practice for most haemorrhoidectomies.
Over the last 2 years,the investigators have performed laser haemorrhoidectomy for 60 patients. The age range was 32 to 81 years .The ratio for male: female was 31:29. All were done under local anaesthesia with sedation except one (1.6%) which was converted to general anaesthesia. All patients except 2 (3.5%) were discharged within two hours of operation. One was delayed due to administration of general anaesthesia and the second one was admitted for post operative bleeding and was actively observed for three days, after which he was discharged. There were four re-admissions (6.6%), two had post operative oedema \& two had oedema and pain. All of them were actively observed and discharged later. Four patients (6.6%) also developed chronic anal fissures post operatively, two of them healed with six weeks course of Glyceryl Tri Nitrate (GTN) cream and the other two are on conservative management for non-healing fissures.
The investigators wish to objectively determine whether laser closed haemorrhoidectomy is associated with significantly less post operative pain and an earlier return to function in comparison to the Milligan-Morgan Haemorrhoidectomy which is the standard procedure performed across the trust.
- Conditions
- Haemorrhoids, Haemorrhoidectomy, Milligan-Morgan Haemorrhoidectomy, Open Haemorrhoidectomy
- Being tested
- Laser Haemorrhoidectomy
- Keywords
- Haemorrhoids, Haemorrhoidectomy, Laser Haemorrhoidectomy, Milligan-Morgan Haemorrhoidectomy, Open Haemorrhoidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser HaemorrhoidectomyProcedure or surgery
Also called Laser Seal Haemorrhoidectomy
The intervention comprises laser haemorrhoidectomy
This procedure will be performed under local anaesthetic with sedation as a day case
The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser.
Pre-operative local anaesthesia will be given
Laser HaemorrhoidectomyProcedure or surgery
The intervention comprises laser haemorrhoidectomy
This procedure will be performed under local anaesthetic with sedation as a day case
The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser.
Pre-operative local anaesthesia will be given
| Study group | Role | What they receive |
|---|---|---|
| Milligan-Morgan Haemorrhoidectomy | Active comparator | Control arm Receives: Procedure: Laser Haemorrhoidectomy |
| Laser Haemorrhoidectomy | Experimental | This new method of haemorrhoidectomy is being compared to the standard Milligan-Morgan Haemorrhoidectomy. Receives: Procedure: Laser Haemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain relief
Visual Analogue Score (1 to 10) willbe used to quantitatively assess pain outcomes.
Measured: 6 weeks post-operatively
Secondary outcomes (2)
Quality of life
SF12 forms will be filled by the patients pre-operatively and again at 6 weeks post-operatively to assess any change in the quality of life this procedure may provide and compare the results between the two procedures.
Measured: Immediately pre-operatively and again at 6 weeks post-operatively
analgesia consumption
patients maintain a pain medication diary in which they document the amount of analgesia they have consumed in the post-operative period.
They are all given a standard regime of analgesics post-operatively unless there are any contra-indications.
Measured: 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr PJ Moore, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
- Investigators
- Peter J Moore, MD, FRCS, Principal investigator, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342991
- Sponsor's protocol ID
- 09/H1305/59
- Status last verified
- Nov 2011
- First submitted
- 14 Apr 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Open Milligan-Morgan Haemorrhoidectomy Versus Laser Closed Haemorrhoidectomy
- ClinicalTrials.gov ID
- NCT01342991
- Acronym / sponsor ID
- 09/H1305/59
- Conditions
- Haemorrhoids, Haemorrhoidectomy, Milligan-Morgan Haemorrhoidectomy, Open Haemorrhoidectomy
- Keywords
- Haemorrhoids, Haemorrhoidectomy, Laser Haemorrhoidectomy, Milligan-Morgan Haemorrhoidectomy, Open Haemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern Lincolnshire and Goole Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Apr 2011 (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 is a randomised trial to compare both the procedures and the difference in their immediate postoperative pain, recovery and quality of life.
Detailed description
Haemorrhoidectomy (excision of haemorrhoids) is the procedure of choice for grade 3 \& 4 symptomatic haemorrhoids. The standard technique in the UK (open Milligan-Morgan) is to excise the haemorrhoids under general anaesthetic (typically using electrocautery) leaving raw areas in anal canal. As a result, patients often experience significant post operative pain which can impact on patient function for weeks following surgery. This would be considered as the gold standard for the operative treatment for haemorrhoids. Due to the difficult post operative recovery of this procedure, alternative techniques for performing haemorrhoidectomy have been explored. One approach, which is gaining some popularity, is stapled haemorrhoidectomy [1]. In this technique, a circular stapling device is used to excise proximal mucosa in order to disconnect the haemorrhoidal blood supply and to pull up the haemorrhoidal mass. The edges of the excised mucosa are simultaneously closed with a row of staples. In a recent meta-analysis of 29 randomised controlled trials including 2056 patients, stapled haemorrhoidectomy was associated with reduced postoperative pain and reduction in return to activity by nearly 12 days in comparison to open haemorrhoidectomy [2]. Although postoperative complication rates were similar, stapled haemorrhoidectomy was associated with significantly more recurrences in the longer term (relative risk 2.29). The stapled haemorrhoidectomy technique has not gained universal acceptance. This may be related to the cost and availability of stapling devices in many centres.
Unlike specialized stapling devices, lasers are widely available in the operating theatre and are used in many operations to cauterise tissue. The resulting burn is superficial in comparison to electrocautery. Consequently, lasers have been used to perform open haemorrhoidectomy with the expectation of reducing post operative pain. However, randomised trials comparing the use of lasers versus cold scalpel for open haemorrhoidectomy have shown no significant differences in post operative pain [3]. Although, the laser appears to offer no advantage in open haemorrhoidal procedures, an alternative technique for laser haemorrhoidectomy has been developed by Peter Thompson from Laser Haemorrhoid Centre in Phoenix, Arizona. In this alternative technique, a laser is used to seal the raw mucosal edges after excision of the piles. In common with stapled haemorrhoidectomy, the mucosa is sealed closed rather than left open. Consequently, patients appear to experience markedly less post operative pain. The technique is also simple and quick with a shallow learning curve. Due to the speed and relative comfort of the procedure, patients may be routinely operated on using sedation and local anaesthetic, rather than full general anaesthetic which is standard practice for most haemorrhoidectomies.
Over the last 2 years,the investigators have performed laser haemorrhoidectomy for 60 patients. The age range was 32 to 81 years .The ratio for male: female was 31:29. All were done under local anaesthesia with sedation except one (1.6%) which was converted to general anaesthesia. All patients except 2 (3.5%) were discharged within two hours of operation. One was delayed due to administration of general anaesthesia and the second one was admitted for post operative bleeding and was actively observed for three days, after which he was discharged. There were four re-admissions (6.6%), two had post operative oedema \& two had oedema and pain. All of them were actively observed and discharged later. Four patients (6.6%) also developed chronic anal fissures post operatively, two of them healed with six weeks course of Glyceryl Tri Nitrate (GTN) cream and the other two are on conservative management for non-healing fissures.
The investigators wish to objectively determine whether laser closed haemorrhoidectomy is associated with significantly less post operative pain and an earlier return to function in comparison to the Milligan-Morgan Haemorrhoidectomy which is the standard procedure performed across the trust.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milligan-Morgan Haemorrhoidectomy | Active comparator | Procedure: Laser HaemorrhoidectomyControl arm |
| Laser Haemorrhoidectomy | Experimental | Procedure: Laser HaemorrhoidectomyThis new method of haemorrhoidectomy is being compared to the standard Milligan-Morgan Haemorrhoidectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are fit enough to undergo general anaesthesia
- Are between the age of 18 and 80 years
- Are able and willing to provide informed consent
- Show no preference to either operative procedure and agree to randomization
- No contra-indications to receiving laser treatment
Key exclusion criteria (6 listed)
- Are not fit enough to undergo a general anaesthesia
- Are not over the age of 18 years
- Are unable or unwilling to provide informed consent
- Have stated their operation preference
- Have any contra-indication preventing them from receiving laser treatment
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 |
|---|---|---|
| Laser HaemorrhoidectomyAlso: Laser Seal HaemorrhoidectomyThe intervention comprises laser haemorrhoidectomy This procedure will be performed under local anaesthetic with sedation as a day case The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser. Pre-operative local anaesthesia will be given | Procedure or surgery | Milligan-Morgan Haemorrhoidectomy |
| Laser HaemorrhoidectomyThe intervention comprises laser haemorrhoidectomy This procedure will be performed under local anaesthetic with sedation as a day case The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser. Pre-operative local anaesthesia will be given | Procedure or surgery | Laser Haemorrhoidectomy |
Primary outcome
Post operative pain relief
Time frame: 6 weeks post-operatively
Visual Analogue Score (1 to 10) willbe used to quantitatively assess pain outcomes.
2 secondary outcomes
Quality of life
Time frame: Immediately pre-operatively and again at 6 weeks post-operatively
analgesia consumption
Time frame: 6 weeks post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
Related trials for Haemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
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.
Peter J Moore, MD, FRCS principal investigator
Northern Lincolnshire and Goole Hospitals NHS Foundation 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 Laser Haemorrhoidectomy in people with Haemorrhoids and Haemorrhoidectomy, run by Northern Lincolnshire and Goole Hospitals NHS Foundation 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 6 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: finished, as of the sponsor's last update on 29 Nov 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post operative pain relief (time frame: 6 weeks post-operatively). 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 29 Nov 2011.