HemorrhoidsLDHLANCT00617448
Ligasure Versus Diathermy Haemorrhoidectomy Under Local Anesthesia
A study testing diathermy haemorrhoidectomy under espinal anesthesia, diathermy haemorrhoidectomy under local anesthesia and Ligasure haemorrhoidetomy under spinal anestesia in people with Hemorrhoids, run by Hospital de Viladecans at 1 site in Spain.
Trial summary
The objective of this prospective randomised trial was to compare the short- and long-term efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to assess the short-term outcome of each procedure performed either under spinal anaesthesia or local anaesthesia with pudendal block with… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- diathermy haemorrhoidectomy under espinal anesthesia, diathermy haemorrhoidectomy under local anesthesia and Ligasure haemorrhoidetomy under spinal anestesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- May 2005to Jun 2007
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a long-standing history of symptomatic grade III or IV haemorrhoids
Who cannot join
- previous anal surgery, concomitant anal disease (fissure, fistula, incontinence and inflammatory bowel disease), use of anticoagulants or analgesics, known hypersensitivity to local anaesthetics and the inability to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de Viladecans (Departement of surgery: coloproctology)
Viladecans, Barcelona, 08840
About this study
Official title: Ligasure™ Versus Diathermy Haemorrhoidectomy Under Spinal or Local Anaesthesia With Ropivacaine. A Randomized Study With One Year Follow-up
The objective of this prospective randomised trial was to compare the short- and long-term efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to assess the short-term outcome of each procedure performed either under spinal anaesthesia or local anaesthesia with pudendal block with ropivacaine combined with intravenous sedation.
We think, Ligasure haemorrhoidectomy under local anesthesia can be performed as day-case procedure and with equal results at long-term than conventional diathermy (considered goal standar of haemorrhoidectomy).
Read the detailed description
Seventy-four consecutive patients with a long-standing history of symptomatic grade III or IV haemorrhoids were assigned randomly by means of a computer-generated list to conventional diathermy haemorrhoidectomy under spinal anaesthesia (group I); conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II); Ligasure™ under spinal anaesthesia (group III) and Ligasure™ with local anaesthesia combined with intravenous sedation (group IV). Allocations were sealed in opaque numbered envelopes. All patients were operated on electively and by the same surgical team (two colorectal surgeons) and variables were collected after operation by an independent observer who was unaware of the operation performed.
The intraoperative time was measured. Intraoperative and early (within the first 48 h) postoperative complications associated with the surgical procedure and complications related to the anaesthetic technique (headache, vomiting, nausea, acute urinary retention, bleeding and hypotension) were recorded. A 100-mm visual analogue scale (VAS) was used to assess the intensity of pain, which was measured at 2, 6 and 24 hours postoperatively and during the first bowel movement. Seven days after surgery, patients were contacted by phone and the following data were recorded: VAS score at rest and during bowel movements, bleeding (categorised as 0 = none, 1 = occasional with defecation, 2 = with each defecation, 3 = with and without defecation) and pruritus (categorised as 0 = none, 1 = occasional, 2 = frequent) and tenesmus (categorised as 0 = none, 1 = occasional, 2 = frequent). These variables were collected at 4 and 12 months after operation by an independent observer who was unaware of the operation performed. Clinical evaluation at 1 year included relapse, continence according to the incontinence score system of Jorge and Wexner19, anal stenosis, presence of skin tags, patient's degree of satisfaction (where 0 corresponded to a unsatisfactory result and 10 an excellent result) and days of sick leave.
- Conditions
- Hemorrhoids
- Being tested
- diathermy haemorrhoidectomy under espinal anesthesia, diathermy haemorrhoidectomy under local anesthesia, Ligasure haemorrhoidetomy under spinal anestesia, Ligasure haemorrhoidectomy under local anesthesia
- Keywords
- diathermy hemorrhoids, Ligasure, randomized controlled trial, Postoperative pain, Surgical Procedure, Ambulatory, Local Anesthesia, Safety procedure long term, Day Surgery
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diathermy haemorrhoidectomy under espinal anesthesiaProcedure or surgery
Also called diathermy excision haemorrhoids regional, open haemorrhoidectomy, regional anesthesia
For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.
diathermy haemorrhoidectomy under local anesthesiaProcedure or surgery
Also called diathermy excision haemorrhoids regional, open haemorrhoidectomy, perianal anesthetics infiltration, pudendal block
For surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan). For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
Ligasure haemorrhoidetomy under spinal anestesiaProcedure or surgery
Also called regional anesthesia, Ligasure for prolapsed piles
For surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia.
Ligasure haemorrhoidectomy under local anesthesiaProcedure or surgery
Also called Ligasure for prolapsed piles, Pudendal block
For surgery: haemorrhoidectomy with Ligasure For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | conventional diathermy haemorrhoidectomy under spinal anaesthesia Receives: Procedure: diathermy haemorrhoidectomy under espinal anesthesia |
| II | Active comparator | conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II) Receives: Procedure: diathermy haemorrhoidectomy under local anesthesia |
| III | Active comparator | Ligasure haemorrhoidectomy under spinal anesthesia Receives: Procedure: Ligasure haemorrhoidetomy under spinal anestesia |
| IV | Active comparator | Ligasure haemorrhoidectomy under local anesthesia Receives: Procedure: Ligasure haemorrhoidectomy under local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause morbility within the first 7 days after surgery (consequence of surgery and anesthesia) and results sintomatology since 12 months
Measured: at 2, 6, 24 horus, 7 days, 4 and 12 monts after surgery
Secondary outcomes (1)
intraoperative time, postoperative complications, pain (VAS), bleeding, pruritus and tenemus, continence ( score system of Jorge and Wexner), anal stenosis, presence of skin tags, degree of satisfaction and days of sick leave.
Measured: Intraoperative, at 2,6,24 hours and 7 days after surgery and 4 and 12 monts after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startMay 2005
- Primary completionJun 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies 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
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Viladecans
- Sponsor type
- University, hospital or other
- Investigators
- Pi F Siques, Professor, Principal investigator, Barcelona university of Medicine (Departement Ciencies Cliniques)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617448
- Sponsor's protocol ID
- 05/0008
- Acronym
- LDHLA
- Status last verified
- Feb 2008
- First submitted
- 5 Feb 2008
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jayne DG, Botterill I, Ambrose NS, Brennan TG, Guillou PJ, O'Riordain DS. Randomized clinical trial of Ligasure versus conventional diathermy for day-case haemorrhoidectomy. Br J Surg. 2002 Apr;89(4):428-32. doi: 10.1046/j.0007-1323.2002.02056.x.
PubMed 11952582Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of Ligasure versus open haemorrhoidectomy. Br J Surg. 2002 Feb;89(2):154-7. doi: 10.1046/j.0007-1323.2001.01993.x.
PubMed 11856126Peters CJ, Botterill I, Ambrose NS, Hick D, Casey J, Jayne DG. Ligasure trademark vs conventional diathermy haemorrhoidectomy: long-term follow-up of a randomised clinical trial. Colorectal Dis. 2005 Jul;7(4):350-3. doi: 10.1111/j.1463-1318.2005.00817.x.
PubMed 15932557Basdanis G, Papadopoulos VN, Michalopoulos A, Apostolidis S, Harlaftis N. Randomized clinical trial of stapled hemorrhoidectomy vs open with Ligasure for prolapsed piles. Surg Endosc. 2005 Feb;19(2):235-9. doi: 10.1007/s00464-004-9098-0. Epub 2004 Dec 2.
PubMed 15573239Masoni L, La Torre F, Otti M, Pascarella G, Gasparrini M, Riso V, Cottini F, Montori A. [Hemorrhoidectomy with ropivacaine (Naropin) local anesthesia. Preliminary experience]. Minerva Chir. 2000 May;55(5):383-7. Italian.
PubMed 10953578Lohsiriwat D, Lohsiriwat V. Outpatient hemorrhoidectomy under perianal anesthetics infiltration. J Med Assoc Thai. 2005 Dec;88(12):1821-4.
PubMed 16518980Vinson-Bonnet B, Coltat JC, Fingerhut A, Bonnet F. Local infiltration with ropivacaine improves immediate postoperative pain control after hemorrhoidal surgery. Dis Colon Rectum. 2002 Jan;45(1):104-8. doi: 10.1007/s10350-004-6121-4.
PubMed 11786772Kim J, Lee DS, Jang SM, Shim MC, Jee DL. The effect of pudendal block on voiding after hemorrhoidectomy. Dis Colon Rectum. 2005 Mar;48(3):518-23. doi: 10.1007/s10350-004-0798-2.
PubMed 15875295Haveran LA, Sturrock PR, Sun MY, McDade J, Singla S, Paterson CA, Counihan TC. Simple harmonic scalpel hemorrhoidectomy utilizing local anesthesia combined with intravenous sedation: a safe and rapid alternative to conventional hemorrhoidectomy. Int J Colorectal Dis. 2007 Jul;22(7):801-6. doi: 10.1007/s00384-006-0242-2. Epub 2006 Nov 22.
PubMed 17119982
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligasure™ Versus Diathermy Haemorrhoidectomy Under Spinal or Local Anaesthesia With Ropivacaine. A Randomized Study With One Year Follow-up
- ClinicalTrials.gov ID
- NCT00617448
- Acronym / sponsor ID
- LDHLA / 05/0008
- Conditions
- Hemorrhoids
- Keywords
- diathermy hemorrhoids, Ligasure, randomized controlled trial, Postoperative pain, Surgical Procedure, Ambulatory, Local Anesthesia, Safety procedure long term, Day Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospital de ViladecansUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Feb 2008 (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.
The objective of this prospective randomised trial was to compare the short- and long-term efficacy of conventional diathermy haemorrhoidectomy versus Ligasure™ diathermy, and to assess the short-term outcome of each procedure performed either under spinal anaesthesia or local anaesthesia with pudendal block with ropivacaine combined with intravenous sedation.
We think, Ligasure haemorrhoidectomy under local anesthesia can be performed as day-case procedure and with equal results at long-term than conventional diathermy (considered goal standar of haemorrhoidectomy).
Detailed description
Seventy-four consecutive patients with a long-standing history of symptomatic grade III or IV haemorrhoids were assigned randomly by means of a computer-generated list to conventional diathermy haemorrhoidectomy under spinal anaesthesia (group I); conventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II); Ligasure™ under spinal anaesthesia (group III) and Ligasure™ with local anaesthesia combined with intravenous sedation (group IV). Allocations were sealed in opaque numbered envelopes. All patients were operated on electively and by the same surgical team (two colorectal surgeons) and variables were collected after operation by an independent observer who was unaware of the operation performed.
The intraoperative time was measured. Intraoperative and early (within the first 48 h) postoperative complications associated with the surgical procedure and complications related to the anaesthetic technique (headache, vomiting, nausea, acute urinary retention, bleeding and hypotension) were recorded. A 100-mm visual analogue scale (VAS) was used to assess the intensity of pain, which was measured at 2, 6 and 24 hours postoperatively and during the first bowel movement. Seven days after surgery, patients were contacted by phone and the following data were recorded: VAS score at rest and during bowel movements, bleeding (categorised as 0 = none, 1 = occasional with defecation, 2 = with each defecation, 3 = with and without defecation) and pruritus (categorised as 0 = none, 1 = occasional, 2 = frequent) and tenesmus (categorised as 0 = none, 1 = occasional, 2 = frequent). These variables were collected at 4 and 12 months after operation by an independent observer who was unaware of the operation performed. Clinical evaluation at 1 year included relapse, continence according to the incontinence score system of Jorge and Wexner19, anal stenosis, presence of skin tags, patient's degree of satisfaction (where 0 corresponded to a unsatisfactory result and 10 an excellent result) and days of sick leave.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: diathermy haemorrhoidectomy under espinal anesthesiaconventional diathermy haemorrhoidectomy under spinal anaesthesia |
| II | Active comparator | Procedure: diathermy haemorrhoidectomy under local anesthesiaconventional diathermy haemorrhoidectomy with local anaesthesia combined with intravenous sedation (group II) |
| III | Active comparator | Procedure: Ligasure haemorrhoidetomy under spinal anestesiaLigasure haemorrhoidectomy under spinal anesthesia |
| IV | Active comparator | Procedure: Ligasure haemorrhoidectomy under local anesthesiaLigasure haemorrhoidectomy under local anesthesia |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a long-standing history of symptomatic grade III or IV haemorrhoids
Key exclusion criteria (1 listed)
- previous anal surgery, concomitant anal disease (fissure, fistula, incontinence and inflammatory bowel disease), use of anticoagulants or analgesics, known hypersensitivity to local anaesthetics and the inability to give written informed consent.
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 |
|---|---|---|
| diathermy haemorrhoidectomy under espinal anesthesiaAlso: diathermy excision haemorrhoids regional, open haemorrhoidectomy, regional anesthesiaFor surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan).For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia. | Procedure or surgery | I |
| diathermy haemorrhoidectomy under local anesthesiaAlso: diathermy excision haemorrhoids regional, open haemorrhoidectomy, perianal anesthetics infiltration, pudendal blockFor surgery: conventional haemorrhoidectomy with diathermy (Milligan-Morgan). For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1 | Procedure or surgery | II |
| Ligasure haemorrhoidetomy under spinal anestesiaAlso: regional anesthesia, Ligasure for prolapsed pilesFor surgery: ligasure haemorrhoidectomy For anesthesia: lidocaine 2% at doses of 50-70 mg was used for spinal anaesthesia. | Procedure or surgery | III |
| Ligasure haemorrhoidectomy under local anesthesiaAlso: Ligasure for prolapsed piles, Pudendal blockFor surgery: haemorrhoidectomy with Ligasure For anesthesia: pudendal nerve block, infiltration of the right and left pararectal spaces, anterior and presacral regions with ropivacaine (150 mg of ropivacaine [20 mL, 7.5 mg/mL] diluted in 50 mL of 0.9% physiological saline). Ten minutes before local anaesthesia, patients were sedated with i.v. remifentanil 0.05-0.15 μg·kg-1 | Procedure or surgery | IV |
Primary outcome
all cause morbility within the first 7 days after surgery (consequence of surgery and anesthesia) and results sintomatology since 12 months
Time frame: at 2, 6, 24 horus, 7 days, 4 and 12 monts after surgery
1 secondary outcome
intraoperative time, postoperative complications, pain (VAS), bleeding, pruritus and tenemus, continence ( score system of Jorge and Wexner), anal stenosis, presence of skin tags, degree of satisfaction and days of sick leave.
Time frame: Intraoperative, at 2,6,24 hours and 7 days after surgery and 4 and 12 monts after surgery
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 18 Feb 2008.
- Results publication: PubMed 11952582Jayne DG, Botterill I, Ambrose NS, Brennan TG, Guillou PJ, O'Riordain DS. Randomized clinical trial of Ligasure versus conventional diathermy for day-case haemorrhoidectomy. Br J Surg. 2002 Apr;89(4):428-32. doi: 10.1046/j.0007-1323.2002.02056.x.
- Results publication: PubMed 11856126Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of Ligasure versus open haemorrhoidectomy. Br J Surg. 2002 Feb;89(2):154-7. doi: 10.1046/j.0007-1323.2001.01993.x.
- Results publication: PubMed 15932557Peters CJ, Botterill I, Ambrose NS, Hick D, Casey J, Jayne DG. Ligasure trademark vs conventional diathermy haemorrhoidectomy: long-term follow-up of a randomised clinical trial. Colorectal Dis. 2005 Jul;7(4):350-3. doi: 10.1111/j.1463-1318.2005.00817.x.
- Results publication: PubMed 15573239Basdanis G, Papadopoulos VN, Michalopoulos A, Apostolidis S, Harlaftis N. Randomized clinical trial of stapled hemorrhoidectomy vs open with Ligasure for prolapsed piles. Surg Endosc. 2005 Feb;19(2):235-9. doi: 10.1007/s00464-004-9098-0. Epub 2004 Dec 2.
- Results publication: PubMed 10953578Masoni L, La Torre F, Otti M, Pascarella G, Gasparrini M, Riso V, Cottini F, Montori A. [Hemorrhoidectomy with ropivacaine (Naropin) local anesthesia. Preliminary experience]. Minerva Chir. 2000 May;55(5):383-7. Italian.
- Results publication: PubMed 16518980Lohsiriwat D, Lohsiriwat V. Outpatient hemorrhoidectomy under perianal anesthetics infiltration. J Med Assoc Thai. 2005 Dec;88(12):1821-4.
- Results publication: PubMed 11786772Vinson-Bonnet B, Coltat JC, Fingerhut A, Bonnet F. Local infiltration with ropivacaine improves immediate postoperative pain control after hemorrhoidal surgery. Dis Colon Rectum. 2002 Jan;45(1):104-8. doi: 10.1007/s10350-004-6121-4.
- Results publication: PubMed 15875295Kim J, Lee DS, Jang SM, Shim MC, Jee DL. The effect of pudendal block on voiding after hemorrhoidectomy. Dis Colon Rectum. 2005 Mar;48(3):518-23. doi: 10.1007/s10350-004-0798-2.
- Results publication: PubMed 17119982Haveran LA, Sturrock PR, Sun MY, McDade J, Singla S, Paterson CA, Counihan TC. Simple harmonic scalpel hemorrhoidectomy utilizing local anesthesia combined with intravenous sedation: a safe and rapid alternative to conventional hemorrhoidectomy. Int J Colorectal Dis. 2007 Jul;22(7):801-6. doi: 10.1007/s00384-006-0242-2. Epub 2006 Nov 22.
Related trials for Hemorrhoids
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.
Pi F Siques, Professor principal investigator
Barcelona university of Medicine (Departement Ciencies Cliniques)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diathermy haemorrhoidectomy under espinal anesthesia, diathermy haemorrhoidectomy under local anesthesia and Ligasure haemorrhoidetomy under spinal anestesia in people with Hemorrhoids, run by Hospital de Viladecans at 1 site in Spain.
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 1 inclusion and 1 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 18 Feb 2008. 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 Spain. 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?
all cause morbility within the first 7 days after surgery (consequence of surgery and anesthesia) and results sintomatology since 12 months (time frame: at 2, 6, 24 horus, 7 days, 4 and 12 monts after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00617448, which also lists 9 linked publications.
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 18 Feb 2008.