Pain, Postoperative Clinical Trial
Official title:
Comparison Study: Ligasure Versus Conventional Hemorrhoidectomy in III and IV Degree Hemorrhoids.
Verified date | February 2019 |
Source | Services Hospital, Lahore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A comparison study was performed between Ligasure and Milligan morgan hemorrhoidectomy to find out the outcome between these two techniques in 3rd and 4th degree hemorrhoids.This advance vessel sealing device is used to seal the pedicle of the vessel and does not burn the surrounding tissues , so the outcome was monitored in terms of operative time, post operative pain pain, duration of wound healing in 3 weeks and return to normal activities
Status | Completed |
Enrollment | 100 |
Est. completion date | September 30, 2014 |
Est. primary completion date | September 30, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility |
Inclusion Criteria: - patients with III and IV degree hemorrhoids assessed on proctoscopy had been included in this study. Exclusion Criteria: - Patients with permanently prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy - Any other anorectal pathology on history and per rectal examination - Previous anal surgery assessed by history and per rectal examination - Inability to give informed consent - ASA(American Society of Anesthesiologists) grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic and renal profile and evidence of ischemic heart disease |
Country | Name | City | State |
---|---|---|---|
Pakistan | services Hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Services Hospital, Lahore |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | operative time | was measured from start of incision to the dressing in minutes | each participant was measured from the start of operation till the dressing i.e duration of 20 minutes to 60 minutes | |
Primary | mean postoperative pain | on Visual analogue scale,a scale to assess the post operative pain ,8-10 as maximum pain, 5-7 as moderate pain, 2-4 minimum pain, 1-0 as no pain and change in final outcome has been assessed after 48 hours | each participant was individually assessed after operation in 6 hours,24 hours and 48 hours post-operative and changes noted in 48 hours | |
Primary | wound healing | assessed in scheduled appointment every week and has been defined as complete epithelization on physical examination .Wound was graded as 1-sloughy, 2-no granulation, 3-granulation, 4-epithelizing , 5-completely epithelized | to assess change in the parameter in 3 weeks | |
Primary | Return to work | has been defined as day of discharge till resume of work that is patient is able to perform daily routine activities normally as before operation. | assessed individually from the day of surgery to resume of daily activities i.e 1 to 7 days |
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