Haemorrhoidectomy by Ligasure and Conventional Surgery
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|ClinicalTrials.gov Identifier: NCT03265990|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ligature; Hemorrhage||Procedure: ligasure haemroidectomy Procedure: Conventional haemorrhoidectomy||Not Applicable|
Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture which may lead to some postoperative complications mostly pain, bleeding and wound infection which ultimately cause prolonged stay in hospital.
A number of surgeons believe that by avoiding vascular pedicle ligation the chances of secondary bleeding can be decreased .This stimulated the researchers to develop new techniques with a less severe course and faster recovery . Recent advances in instrumental technology including the bipolar electrothermal device, ultrasonic scalpel, and circular stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these instruments, the LigaSure vessel sealing system has been recently introduced as a tool conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast healing . .Thus this operation can be recommended as the ideal technique. Many trials were performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although an overall favorable trend exists toward LigaSure, conclusions are not univocal and definitive; this creates some uncertainty, also considering the increasing cost for this disposable device: thus it is essential to keep on experimenting to determine whenever an actual advantage exists.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||February 1, 2019|
Experimental: Group A
Conventional haemrrhoidectomy,Ferguson technique
Procedure: Conventional haemorrhoidectomy
According to the Ferguson technique
After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed.
Experimental: Group B
Procedure: ligasure haemroidectomy
In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.
- Post operative pain [ Time Frame: 1 month ]pain will be evaluated with visual analogue scale
- Intra operative blood loss [ Time Frame: 1 day ]Amount of blood loss by cc during surgery
- Wound healing [ Time Frame: 2 months ]the healing of mucosa and skin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265990
|Contact: Abdel Rhman Refaie Kamel||01097722233||Refaay120@gmail.com|