Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate that postoperative pain secondary to Milligan and Morgan hemorrhoidectomy with CaimanĀ® (AESCULAPĀ®) 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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Conventional hemorrhoidectomy with monopolar diathermy + intravenous analgesia with elastomeric pump + discharge with home hospitalization. |
|
| Experimental | Experimental | conventional haemorrhoidectomy with CaimanĀ® bipolar energy (AESCULAPĀ®) + oral conventional analgesia + conventional home discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monopolar Hemorroidecotmy | Procedure | Hemorrhoidectomy with monopolar diathermy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) | Postoperative pain: value 0 (no pain) - 10 (maximum pain) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing time | A healed wound is considered when all post-hemorrhoidectomy wounds of 2-3 bundles are epithelialized | 7 days postoperative control at external consultations; 30 days postoperative control at external consultations |
| Post-surgery satisfaction survey |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Mora | Contact | 34 937211010 | 21490 | mora.lopez.laura@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Laura Mora | Parc Tauli University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Mora López | Recruiting | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22895941 | Background | 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. | |
| 16235372 | Background | Alonso-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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Non-inferiority, prospective, randomized, single-center, parallel-group clinical trial.
Not provided
Not provided
Not provided
Not provided
| Caiman Hemorroidectomy |
| Procedure |
Hemorrhoidectomy with CaimanĀ® bipolar energy |
|
Phone checklist survey |
| 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. | in pre-operative visit, on the 7th and 30th postoperative clinical control |
| Number of emergency consultations | revision of Database | in 30 days post-surgery |
| Collection of adverse effects from patients | revision of Database | in 30 days post-surgery |
| 16034963 | Background | Shanmugam 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. |
| 27960130 | Background | Medina-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. |
| 19160300 | Background | Nienhuijs 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. |
| 21991510 | Background | Gentile 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. |
| 24141714 | Background | World 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. |
| 27440100 | Background | Chan 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. |