Hemorrhoid PainTAUHEMORNCT06535269
Postoperative Pain in the Surgical Treatment of Hemorrhoids: Conventional Hemorrhoidectomy With a Monopolar Electric Scaler VS Bipolar Energy With Caiman® (Aesculap®)
A study testing Monopolar Hemorroidecotmy and Caiman Hemorroidectomy in people with Hemorrhoid Pain and Hemorrhoidectomy, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoid Pain, Hemorrhoidectomy
- What is being tested?
- Monopolar Hemorroidecotmy and Caiman Hemorroidectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2022to Jul 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy
- Voluntary participation.
- ASA I-II-III.
Who cannot join
- Failure to meet the inclusion criteria.
- ASA IV.
- Allergic to Paracetamol, derivatives of morphine.
- Allergic to NSAIDs.
- Synchronous colorectal neoplasia.
- Coagulation disorders.
Show all 11Show fewer
- Thrombosed hemorrhoid.
- Inflammatory bowel disease.
- Liver cirrhosis and/or portal hypertension.
- Pregnant women.
- Difficulty following up by phone and/or in person.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Laura Mora López
Sabadell, Barcelona, 08208
Laura Mora, Dr., mora.lopez.laura@gmail.com
About this study
Official title: Prospective Randomized Study on Postoperative Pain in the Surgical Treatment of Hemorrhoids Through Conventional Hemorrhoidectomy With a Monopolar Electric Scalpel or Bipolar Energy With Caiman® (Aesculap®)
To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.
Read the detailed description
In the treatment of coloproctological pathology, one of the most important problems is postoperative pain. Especially in the management of hemorrhoids treatment. There are different approaches but in all of them pain is the predominant symptom.
There are some less painful techniques but the gold standard continues to be hemmorrhoidectomy, which is associated with postoperative pain. Some actions have been taken to control pain to avoid the admission of patients, but there are still problems in this regard.
Our group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.
- Conditions
- Hemorrhoid Pain, Hemorrhoidectomy
- Being tested
- Monopolar Hemorroidecotmy, Caiman Hemorroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar HemorroidecotmyProcedure or surgery
Hemorrhoidectomy with monopolar diathermy
Caiman HemorroidectomyProcedure or surgery
Hemorrhoidectomy with Caiman® bipolar energy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization. Receives: Procedure: Monopolar Hemorroidecotmy |
| Experimental | Experimental | conventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge. Receives: Procedure: Caiman Hemorroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Postoperative pain: value 0 (no pain) - 10 (maximum pain)
Measured: 6 hours of post-operative period (before hospital discharge performed); within 2 days with telephone control; at 7 days control at external consultations; at 30 days control at external consultations
Secondary outcomes (5)
Wound healing time
A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized
Measured: 7 days postoperative control at external consultations; 30 days postoperative control at external consultations
Post-surgery satisfaction survey
Phone checklist survey
Measured: 30 days postoperative control at external consultations
Wexner scale
Assessment of fecal incontinence o a scale from 0 (never incontinence) to 4 (always), obtaining a score between 0 and 20.
Measured: in pre-operative visit, on the 7th and 30th postoperative clinical control
Number of emergency consultations
revision of Database
Measured: in 30 days post-surgery
Collection of adverse effects from patients
revision of Database
Measured: in 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start2 Nov 2022
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoid PainStudies 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
- Model description
- Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mora-Lopez, Corporacion Parc Tauli
- Investigators
- Laura Mora, Principal investigator, Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535269
- Sponsor's protocol ID
- TAUHEMOR
- Acronym
- TAUHEMOR
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3.
PubMed 22895941Alonso-Coello P, Guyatt G, Heels-Ansdell D, Johanson JF, Lopez-Yarto M, Mills E, Zhou Q. Laxatives for the treatment of hemorrhoids. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD004649. doi: 10.1002/14651858.CD004649.pub2.
PubMed 16235372Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD005034. doi: 10.1002/14651858.CD005034.pub2.
PubMed 16034963Medina-Gallardo A, Curbelo-Pena Y, De Castro X, Roura-Poch P, Roca-Closa J, De Caralt-Mestres E. Is the severe pain after Milligan-Morgan hemorrhoidectomy still currently remaining a major postoperative problem despite being one of the oldest surgical techniques described? A case series of 117 consecutive patients. Int J Surg Case Rep. 2017;30:73-75. doi: 10.1016/j.ijscr.2016.11.018. Epub 2016 Nov 15.
PubMed 27960130Nienhuijs S, de Hingh I. Conventional versus LigaSure hemorrhoidectomy for patients with symptomatic Hemorrhoids. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006761. doi: 10.1002/14651858.CD006761.pub2.
PubMed 19160300Gentile M, De Rosa M, Carbone G, Pilone V, Mosella F, Forestieri P. LigaSure Haemorrhoidectomy versus Conventional Diathermy for IV-Degree Haemorrhoids: Is It the Treatment of Choice? A Randomized, Clinical Trial. ISRN Gastroenterol. 2011;2011:467258. doi: 10.5402/2011/467258. Epub 2010 Nov 21.
PubMed 21991510World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.
PubMed 27440100
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on Postoperative Pain in the Surgical Treatment of Hemorrhoids Through Conventional Hemorrhoidectomy With a Monopolar Electric Scalpel or Bipolar Energy With Caiman® (Aesculap®)
- ClinicalTrials.gov ID
- NCT06535269
- Acronym / sponsor ID
- TAUHEMOR / TAUHEMOR
- Conditions
- Hemorrhoid Pain, Hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 2 Aug 2024 (actual)
- 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.
To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with Caiman® (AESCULAP®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.
Detailed description
In the treatment of coloproctological pathology, one of the most important problems is postoperative pain. Especially in the management of hemorrhoids treatment. There are different approaches but in all of them pain is the predominant symptom.
There are some less painful techniques but the gold standard continues to be hemmorrhoidectomy, which is associated with postoperative pain. Some actions have been taken to control pain to avoid the admission of patients, but there are still problems in this regard.
Our group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Monopolar HemorroidecotmyConventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization. |
| Experimental | Experimental | Procedure: Caiman Hemorroidectomyconventional haemorrhoidectomy with Caiman® bipolar energy (AESCULAP®) + oral conventional analgesia + conventional home discharge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with 2 or 3 bundles of grade III-IV hemorrhoids (Goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy
- Voluntary participation.
- ASA I-II-III.
Key exclusion criteria (11 listed)
- Failure to meet the inclusion criteria.
- ASA IV.
- Allergic to Paracetamol, derivatives of morphine.
- Allergic to NSAIDs.
- Synchronous colorectal neoplasia.
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 |
|---|---|---|
| Monopolar HemorroidecotmyHemorrhoidectomy with monopolar diathermy | Procedure or surgery | Control |
| Caiman HemorroidectomyHemorrhoidectomy with Caiman® bipolar energy | Procedure or surgery | Experimental |
Primary outcome
Visual analogue scale (VAS)
Time frame: 6 hours of post-operative period (before hospital discharge performed); within 2 days with telephone control; at 7 days control at external consultations; at 30 days control at external consultations
Postoperative pain: value 0 (no pain) - 10 (maximum pain)
5 secondary outcomes
Wound healing time
Time frame: 7 days postoperative control at external consultations; 30 days postoperative control at external consultations
Post-surgery satisfaction survey
Time frame: 30 days postoperative control at external consultations
Wexner scale
Time frame: in pre-operative visit, on the 7th and 30th postoperative clinical control
Number of emergency consultations
Time frame: in 30 days post-surgery
Collection of adverse effects from patients
Time frame: in 30 days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 22895941Perera N, Liolitsa D, Iype S, Croxford A, Yassin M, Lang P, Ukaegbu O, van Issum C. Phlebotonics for haemorrhoids. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD004322. doi: 10.1002/14651858.CD004322.pub3.
- Background: PubMed 16235372Alonso-Coello P, Guyatt G, Heels-Ansdell D, Johanson JF, Lopez-Yarto M, Mills E, Zhou Q. Laxatives for the treatment of hemorrhoids. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD004649. doi: 10.1002/14651858.CD004649.pub2.
- Background: PubMed 16034963Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD005034. doi: 10.1002/14651858.CD005034.pub2.
- Background: PubMed 27960130Medina-Gallardo A, Curbelo-Pena Y, De Castro X, Roura-Poch P, Roca-Closa J, De Caralt-Mestres E. Is the severe pain after Milligan-Morgan hemorrhoidectomy still currently remaining a major postoperative problem despite being one of the oldest surgical techniques described? A case series of 117 consecutive patients. Int J Surg Case Rep. 2017;30:73-75. doi: 10.1016/j.ijscr.2016.11.018. Epub 2016 Nov 15.
- Background: PubMed 19160300Nienhuijs S, de Hingh I. Conventional versus LigaSure hemorrhoidectomy for patients with symptomatic Hemorrhoids. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006761. doi: 10.1002/14651858.CD006761.pub2.
- Background: PubMed 21991510Gentile M, De Rosa M, Carbone G, Pilone V, Mosella F, Forestieri P. LigaSure Haemorrhoidectomy versus Conventional Diathermy for IV-Degree Haemorrhoids: Is It the Treatment of Choice? A Randomized, Clinical Trial. ISRN Gastroenterol. 2011;2011:467258. doi: 10.5402/2011/467258. Epub 2010 Nov 21.
- Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Background: PubMed 27440100Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.
- Individual participant dataSharing planned: No
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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.
Laura Mora principal investigator
Parc Tauli University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar Hemorroidecotmy and Caiman Hemorroidectomy in people with Hemorrhoid Pain and Hemorrhoidectomy, run by Corporacion Parc Tauli 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 3 inclusion and 11 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 2 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Mora (34 937211010 ext. 21490, mora.lopez.laura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 6 hours of post-operative period (before hospital discharge performed); within 2 days with telephone control; at 7 days control at external consultations; at 30 days control at external consultations). 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 NCT06535269, which also lists 8 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 2 Aug 2024.